The main purpose of this research study is to find out if de-escalation of chemotherapy before surgery followed by a selective escalation of adjuvant targeted therapies are efficacious and tolerable in early-stage HER2 positive breast cancer.

Start Date11 Aug 2025

Sponsor / Collaborator

University of Rochester

NCT06881017

/ Not yet recruitingPhase 2IIT

Establishment of Precision Targeted Therapy Strategies for Advanced Gastric Cancer Based on Novel Molecular Subtyping: an Umbrella Phase II Exploratory Clinical Study

This study is a prospective, umbrella-design, Phase II clinical trial. Eligible participants with advanced or metastatic gastric cancer who are treatment-naïve for advanced-stage systemic therapy will undergo biomarker profiling (HER2, CLDN18.2, and PD-L1) via next-generation sequencing (NGS) or immunohistochemistry (IHC). Participants will be stratified into distinct molecular subtypes and assigned subtype-specific therapeutic regimens. The primary objectives are to assess treatment efficacy (e.g., objective response rate) and safety profiles across molecularly defined cohorts.

Start Date01 May 2025

Sponsor / Collaborator

China Medical University

NCT06086132

/ Not yet recruitingNot ApplicableIIT

Detection and Prevention of Cancer-Related Cardiovascular Toxicity Registry (ISACS CARDIONCO-PREDICT)

This study is being done in order to assess the cardiovascular events known as cardiovascular toxicity of chemotherapy agents and radiotherapy protocols in cancer subjects to identify risk prediction, prevention and treatment of cancer therapy-related cardiovascular toxicity and cancer therapy-related cardiac dysfunction

Start Date01 Apr 2025

Sponsor / Collaborator

Alma Mater Studiorum - Università di Bologna

[+1]

100 Clinical Results associated with Trastuzumab

100 Translational Medicine associated with Trastuzumab

100 Patents (Medical) associated with Trastuzumab

13,941

Literatures (Medical) associated with Trastuzumab

31 Dec 2025·Human Vaccines & Immunotherapeutics

Discussion on the mechanism of HER2 resistance in esophagogastric junction and gastric cancer in the era of immunotherapy

Review

Author: Li, Weiling ; Zhao, Jun ; Fan, Wenxuan ; Gao, Yangjun ; Su, Fei ; Zhang, Yan ; Hu, Wenqing ; Zhang, Xiaoling ; Du, Yunyi

Human epidermal growth factor receptor 2 (HER2) is a critical biomarker and therapeutic target in gastric/gastroesophageal junction (G/GEJ) cancers, despite the initial success of HER2-targeted therapies, such as trastuzumab, resistance to these drugs has emerged as a major impediment to effective long-term treatment. This review examines the mechanisms of drug resistance in HER2-positive G/GEJ cancer, the primary mechanisms of resistance explored include alterations in the HER2 receptor itself, such as mutations and changes in expression levels, as well as downstream signaling pathways, and interactions with the tumor microenvironment (TME). Furthermore, the review discusses the Novel therapeutic approaches, including the use of antibody-drug conjugates (ADCs) and combination therapies are assessed for their potential to enhance outcomes. By integrating recent research findings and clinical trials, this review aims to provide oncologists and researchers with insights into developing more effective treatments for patients with drug-resistant HER2-positive G/GEJ cancer.

01 Dec 2025·CANCER CHEMOTHERAPY AND PHARMACOLOGY

HER-2 SMASH

Article

Author: Şahin İnan, Zeynep Deniz ; Özkaraca, Mustafa ; Yulak, Fatih ; Altun, Ahmet ; Öztürk, Ayşegül ; Lacın, Burak Batuhan ; Alandağ, Celal

PURPOSE:

Human epidermal growth factor-2 (HER-2) targeted drugs are used in only HER-2 overexpressed cancers. However, only a small portion of these cancer types are HER-2 overexpressed. In this study, we aimed to upregulate HER-2 receptors in MCF-7 breast cancer and HT-29 colon cancer cell cultures, which these cells are not HER-2 upregulated in natural status.

METHODS:

We used a 10-day non-cytotoxic lapatinib dose to upregulate HER-2 receptors. HER-2 levels of these cell lines were tested with ELISA and immunofluorescence tests before and after 10 days of lapatinib administration. After upregulation of HER-2, we administered trastuzumab, and T-DM1 to these cell lines to observe whether there is an increase in anticancer activity. We used a cell viability test to show the cytotoxicity of trastuzumab and T-DM1. Also, we used ELISA and immunofluorescence for HER-2 pathway proteins to understand the mechanism of increased anti-cancer activity.

RESULTS:

We showed that administration of lapatinib for 10 days leads to overexpression of HER-2 receptors on both MCF-7 and HT-29 cells. A significant increase in the cytotoxicity of trastuzumab or T-DM1 was observed after 10 days of lapatinib administration.

CONCLUSION:

We named this method the smash method, which is the volleyball term. In volleyball, the ball is raised while low and quickly hits the ground again, just like we do with the HER-2 receptor. The smash method can switch HER-2 negative or HER-2 low tumors into HER-2 overexpressed, iatrogenically. Thus, we can use her2-targeted therapies in all cancer patients instead of a small portion.

01 Jun 2025·BREAST

A composite 18F-FDG PET/CT and HER2 tissue-based biomarker to predict response to neoadjuvant pertuzumab and trastuzumab in HER2-positive breast cancer (TBCRC026)

Article

Author: Vaklavas, Christos ; Kachergus, Jennifer M ; Ma, Yaohua ; Winer, Eric ; Valero, Vincente ; Solnes, Lilja B ; Rimawi, Mothaffar ; Denbow, Rita ; Huang, Chiung-Yu ; Storniolo, Anna Maria ; Abramson, Vandana G ; Carter, Jodi M ; Cimino-Mathews, Ashley ; Thompson, E Aubrey ; Stearns, Vered ; Leal, Jeffrey P ; Krop, Ian ; Hennessy, Maeve A ; Wahl, Richard L ; Wolff, Antonio C ; Specht, Jennifer ; Connolly, Roisin M ; Carey, Lisa A

BACKGROUND:

Early metabolic change on PET/CT was predictive of response to neoadjuvant trastuzumab/pertuzumab (HP) in TBCRC026. We hypothesized that a composite biomarker incorporating PET/CT and HER2 tissue-based biomarkers could improve biomarker performance.

METHODS:

83 patients with estrogen receptor-negative/HER2-positive breast cancer received neoadjuvant HP alone [pathologic complete response (pCR) 22 %]. PET/CT was performed at baseline and 15 days post initiation of therapy (C1D15). Promising imaging biomarkers included ≥40 % SULmax decline between baseline and C1D15, and C1D15 SULmax ≤3. Baseline tissue-based biomarkers included HER2-enriched intrinsic subtype (72 %, 46/64; NanoString), tumor HER2 protein abundance (median log2 13.5, range log2 7.1-15.9; NanoString DSP), and HER2 3+ (83 %, 64/77; immunohistochemistry). Logistic regressions were fitted to predict pCR with HER2/PET-CT biomarkers. The C statistic assessed overall prediction power. The optimal composite score cut-off was determined by maximizing Youden's index.

RESULTS:

Factors most predictive for pCR in single predictor models included C1D15 SULmax (OR 0.43; p = 0.007, c = 0.77), % reduction in SULmax (OR 1.03, p = 0.006, c = 0.72) and tumor HER2 protein abundance (OR 1.75; p = 0.01, c = 0.76). The composite of C1D15 SULmax and % reduction in SULmax and their interaction term, had improved probability (c = 0.89 from c = 0.78), with high sensitivity (100 %) and negative predictive value (100 %). The addition of tumor HER2 protein did not further improve prediction power (c = 0.90).

CONCLUSION:

The HER2/PET-CT biomarker had high prediction power for pCR, however was not superior to the prediction power of PET/CT alone. Non-invasive PET/CT biomarkers may facilitate a response-guided approach to neoadjuvant therapy, allowing intensification and de-intensification of treatment, pending further evaluation.

681

News (Medical) associated with Trastuzumab

15 hours ago

·pipelinereview.com

Merck’s Investigational Subcutaneous Pembrolizumab With Berahyaluronidase Alfa Demonstrates Noninferior Pharmacokinetics Compared to Intravenous (IV) KEYTRUDA® (pembrolizumab) in Pivotal 3475A-D77 Trial

Subcutaneous pembrolizumab administered every six weeks with a median injection time of two minutes, in combination with chemotherapy, shows consistent results across reported efficacy and safety endpoints compared to IV KEYTRUDA in combination with chemotherapy A time and motion descriptive analysis shows nearly 50% reductions in patient chair and treatment room time, and in total active healthcare professional time related to treatment tasks, for subcutaneous pembrolizumab compared to IV KEYTRUDA Applications for subcutaneous pembrolizumab are under review in the U.S. and Europe RAHWAY, NJ, USA I March 27, 2025 I Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced the first data presentation from the pivotal 3475A-D77 Phase 3 trial, evaluating the subcutaneous administration of pembrolizumab, together with berahyaluronidase alfa (MK-3475A; from now on referred to as “subcutaneous pembrolizumab”). Berahyaluronidase alfa is a variant of human hyaluronidase developed and manufactured by Alteogen Inc. These results are being presented today at the European Lung Cancer Congress (ELCC) 2025 (Abstract #8MO) and published simultaneously in Annals of Oncology. The study met its primary endpoints, demonstrating noninferior pharmacokinetics (PK) for subcutaneous pembrolizumab administered with chemotherapy with a median injection time of two minutes, versus intravenous (IV) KEYTRUDA ® (pembrolizumab) administered with chemotherapy for the first-line treatment of adult patients with metastatic non-small cell lung cancer (NSCLC). The secondary endpoints of objective response rate (ORR), progression-free survival (PFS) and duration of response (DOR) and safety were consistent for subcutaneous pembrolizumab with chemotherapy compared to IV KEYTRUDA with chemotherapy. Median overall survival (OS) was not reached in either arm. Based on these data, the U.S. Food and Drug Administration (FDA) has accepted for review a Biologics License Application (BLA) seeking approval of subcutaneous pembrolizumab across all previously approved solid tumor indications for KEYTRUDA. The FDA has set a Prescription Drug User Fee Act (PDUFA), or target action, date of Sept. 23, 2025. Additionally, the European Medicines Agency (EMA) has validated an extension application to introduce a new pharmaceutical form and new route of administration for KEYTRUDA. In addition, results of a prospective, observational time and motion descriptive analysis conducted alongside study 3475A-D77 show that, compared to IV KEYTRUDA, subcutaneous pembrolizumab reduced time for patients spent in-chair and in the treatment room by 49.7% and 47.4%, respectively, and reduced the total active time spent by healthcare professionals (HCPs) on treatment preparation, administration process and patient monitoring by 45.7%. These results are being presented as a poster at ELCC (Poster #33P). Pharmacokinetic, efficacy, safety and time and motion results are described further below. “These study findings demonstrate subcutaneous pembrolizumab reduces time demands for both the patient and the healthcare provider, all while providing a consistent efficacy and safety profile with IV pembrolizumab,” said Dr. Enriqueta Felip, head of Thoracic Tumors Group, Vall d’Hebron Institute of Oncology. “As a physician, I am thrilled to see these data for subcutaneous pembrolizumab, which, if approved, have the potential to give patients valuable time back in their treatment day with results that are consistent with IV pembrolizumab.” In the 3475A-D77 trial, subcutaneous pembrolizumab, administered every six weeks with a median injection time of two minutes (4.8 mL) along with chemotherapy, demonstrated noninferiority of area under the curve (AUC) exposure of pembrolizumab during the first dosing cycle (geometric mean ratio of 1.14 [96% CI, 1.06-1.22]; p<0.0001) and model-based trough concentration (Ctrough) of pembrolizumab measured at steady state (geometric mean ratio of 1.67 [94% CI, 1.52-1.84]; p<0.0001), compared to IV KEYTRUDA administered every six weeks with chemotherapy. “KEYTRUDA has helped transform the treatment of certain cancers, and we continue to pursue innovations that build on this breakthrough medicine to give patients and those who treat them better experiences,” said Dr. Marjorie Green, senior vice president and head of oncology, global clinical development, Merck Research Laboratories. “If approved, we are excited about the potential of subcutaneous pembrolizumab to become a new meaningful treatment option that may increase access and save time needed for administration compared to IV KEYTRUDA. We look forward to working with global regulatory authorities to bring the first subcutaneous checkpoint inhibitor that can be administered in approximately two minutes to patients and providers.” In the prospective, observational time and motion study, patient time in chair during treatment with pembrolizumab was reduced by 49.7% (weighted means [WM]: 59.0 versus 117.2 minutes) for subcutaneous pembrolizumab with chemotherapy compared to IV KEYTRUDA with chemotherapy. Patients receiving subcutaneous pembrolizumab versus IV KEYTRUDA spent 47.4% less time in the treatment room (WM: 66.7 versus 126.9 minutes). Time associated with chemotherapy administration was removed from chair and treatment room duration. Results also show that subcutaneous pembrolizumab with chemotherapy reduced total active HCP time by 45.7% (WM: 14.0 versus 25.8 minutes;), including 44.6% less time on subcutaneous pembrolizumab preparation (WM: 5.1 versus 9.2 minutes) and 46.7% less time on subcutaneous pembrolizumab administration process and patient monitoring (WM: 8.9 versus 16.7 minutes) compared to IV KEYTRUDA with chemotherapy. The differences as measured by a linear mixed model were statistically significant (p<0.0001) for active HCP and patient time endpoints. In addition to the 3475A-D77 trial, Merck’s subcutaneous pembrolizumab clinical development program includes the 3475A-F84 Phase 3 trial evaluating subcutaneous pembrolizumab administered alone compared to IV KEYTRUDA alone for the first-line treatment of patients with metastatic NSCLC whose tumors have high PD-L1 expression (tumor proportion score [TPS] ≥50%), as well as the 3475A-F65 Phase 2 trial evaluating subcutaneous pembrolizumab administered alone in relapsed or refractory classical Hodgkin lymphoma and relapsed or refractory primary mediastinal large B-cell lymphoma. Merck is also conducting a patient preference Phase 2 study, 3475A-F11, evaluating participant-reported preference for subcutaneous pembrolizumab compared to IV KEYTRUDA. Study design and additional data from 3475A-D77 Study 3475A-D77 is a randomized, open-label Phase 3 trial (ClinicalTrials.gov, NCT05722015 ) evaluating the subcutaneous administration of pembrolizumab together with berahyaluronidase alfa administered every six weeks with chemotherapy compared to IV KEYTRUDA administered every six weeks in combination with chemotherapy for the first-line treatment of adult patients with metastatic NSCLC, regardless of PD-L1 TPS expression. The study is designed to assess the dual primary PK endpoints of the AUC of pembrolizumab exposure during the first dosing cycle and the Ctrough of pembrolizumab measured at steady state. Secondary endpoints include additional PK parameters as well as efficacy (ORR, DOR, PFS and OS) and safety. The trial enrolled 377 patients who were randomized (2:1) to receive either subcutaneous pembrolizumab administered with chemotherapy or IV KEYTRUDA in combination with chemotherapy. Secondary efficacy endpoints of the study, which were descriptive, showed: Among patients who received subcutaneous pembrolizumab with chemotherapy (n=251), Grade ≥3 adverse events (AEs) occurred in 47% of patients versus 47.6% of patients who received IV KEYTRUDA with chemotherapy (n=126). The incidence of local injection site reactions for subcutaneous pembrolizumab with chemotherapy was 2.4%, all of which were low grade. Treatment-related adverse events (TRAEs) led to discontinuation of subcutaneous pembrolizumab in 8.4% of patients in the subcutaneous pembrolizumab with chemotherapy arm and in 8.7% of patients in the IV KEYTRUDA with chemotherapy arm. Additionally, TRAEs led to discontinuation of chemotherapy in 15.1% of patients in the subcutaneous pembrolizumab with chemotherapy arm and 11.9% of patients in the IV KEYTRUDA with chemotherapy arm. Treatment-related deaths occurred in 3.6% of patients who received subcutaneous pembrolizumab with chemotherapy and 2.4% of patients who received IV KEYTRUDA with chemotherapy. Study design from time and motion study The global observational time and motion study enrolled 17 sites across eight countries in Europe (4), South America (3) and Asia (1) from the 3475A-D77 trial. Primary endpoints were patient time in chair during treatment, patient time in treatment room and total active HCP time for tasks related to subcutaneous pembrolizumab preparation, administration process and patient monitoring. Time was measured by trained observers using a stopwatch, and time associated with chemotherapy administration was removed from patient in-chair and treatment room duration. Descriptive statistics were calculated including WM to account for unequal sample sizes across countries in each group. Statistical differences between subcutaneous and IV arms were explored via a linear mixed model. About KEYTRUDA ® (pembrolizumab) injection for intravenous use, 100 mg KEYTRUDA is an anti-programmed death receptor-1 (PD-1) therapy that works by increasing the ability of the body’s immune system to help detect and fight tumor cells. KEYTRUDA is a humanized monoclonal antibody that blocks the interaction between PD-1 and its ligands, PD- L1 and PD-L2, thereby activating T lymphocytes which may affect both tumor cells and healthy cells. Merck has the industry’s largest immuno-oncology clinical research program. There are currently more than 1,600 trials studying KEYTRUDA across a wide variety of cancers and treatment settings. The KEYTRUDA clinical program seeks to understand the role of KEYTRUDA across cancers and the factors that may predict a patient’s likelihood of benefitting from treatment with KEYTRUDA, including exploring several different biomarkers. Selected KEYTRUDA ® (pembrolizumab) Indications in the U.S. Non-Small Cell Lung Cancer KEYTRUDA, in combination with pemetrexed and platinum chemotherapy, is indicated for the first-line treatment of patients with metastatic nonsquamous non-small cell lung cancer (NSCLC), with no EGFR or ALK genomic tumor aberrations. KEYTRUDA, in combination with carboplatin and either paclitaxel or paclitaxel protein-bound, is indicated for the first-line treatment of patients with metastatic squamous NSCLC. KEYTRUDA, as a single agent, is indicated for the first-line treatment of patients with NSCLC expressing PD-L1 [Tumor Proportion Score (TPS) ≥1%] as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations, and is: KEYTRUDA, as a single agent, is indicated for the treatment of patients with metastatic NSCLC whose tumors express PD-L1 (TPS ≥1%) as determined by an FDA-approved test, with disease progression on or after platinum-containing chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving KEYTRUDA. KEYTRUDA is indicated for the treatment of patients with resectable (tumors ≥4 cm or node positive) NSCLC in combination with platinum-containing chemotherapy as neoadjuvant treatment, and then continued as a single agent as adjuvant treatment after surgery. KEYTRUDA, as a single agent, is indicated as adjuvant treatment following resection and platinum-based chemotherapy for adult patients with Stage IB (T2a ≥4 cm), II, or IIIA NSCLC. Melanoma KEYTRUDA is indicated for the treatment of patients with unresectable or metastatic melanoma. KEYTRUDA is indicated for the adjuvant treatment of adult and pediatric (12 years and older) patients with Stage IIB, IIC, or III melanoma following complete resection. Malignant Pleural Mesothelioma KEYTRUDA, in combination with pemetrexed and platinum chemotherapy, is indicated for the first-line treatment of adult patients with unresectable advanced or metastatic malignant pleural mesothelioma (MPM). Head and Neck Squamous Cell Cancer KEYTRUDA, in combination with platinum and fluorouracil (FU), is indicated for the first-line treatment of patients with metastatic or with unresectable, recurrent head and neck squamous cell carcinoma (HNSCC). KEYTRUDA, as a single agent, is indicated for the first-line treatment of patients with metastatic or with unresectable, recurrent HNSCC whose tumors express PD-L1 [Combined Positive Score (CPS) ≥1] as determined by an FDA-approved test. KEYTRUDA, as a single agent, is indicated for the treatment of patients with recurrent or metastatic HNSCC with disease progression on or after platinum-containing chemotherapy. Classical Hodgkin Lymphoma KEYTRUDA is indicated for the treatment of adult patients with relapsed or refractory classical Hodgkin lymphoma (cHL). KEYTRUDA is indicated for the treatment of pediatric patients with refractory cHL, or cHL that has relapsed after 2 or more lines of therapy. Primary Mediastinal Large B-Cell Lymphoma KEYTRUDA is indicated for the treatment of adult and pediatric patients with refractory primary mediastinal large B-cell lymphoma (PMBCL), or who have relapsed after 2 or more prior lines of therapy. KEYTRUDA is not recommended for treatment of patients with PMBCL who require urgent cytoreductive therapy. Urothelial Cancer KEYTRUDA, in combination with enfortumab vedotin, is indicated for the treatment of adult patients with locally advanced or metastatic urothelial cancer. KEYTRUDA, as a single agent, is indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma: KEYTRUDA, as a single agent, is indicated for the treatment of patients with Bacillus Calmette-Guerin (BCG)-unresponsive, high-risk, non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors who are ineligible for or have elected not to undergo cystectomy. Microsatellite Instability-High or Mismatch Repair Deficient Cancer KEYTRUDA is indicated for the treatment of adult and pediatric patients with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) solid tumors, as determined by an FDA-approved test, that have progressed following prior treatment and who have no satisfactory alternative treatment options. Microsatellite Instability-High or Mismatch Repair Deficient Colorectal Cancer KEYTRUDA is indicated for the treatment of patients with unresectable or metastatic MSI-H or dMMR colorectal cancer (CRC) as determined by an FDA-approved test. Gastric Cancer KEYTRUDA, in combination with trastuzumab, fluoropyrimidine- and platinum-containing chemotherapy, is indicated for the first-line treatment of adults with locally advanced unresectable or metastatic HER2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumors express PD-L1 (CPS ≥1) as determined by an FDA-approved test. KEYTRUDA, in combination with fluoropyrimidine- and platinum-containing chemotherapy, is indicated for the first-line treatment of adults with locally advanced unresectable or metastatic HER2-negative gastric or gastroesophageal junction (GEJ) adenocarcinoma. Esophageal Cancer KEYTRUDA is indicated for the treatment of patients with locally advanced or metastatic esophageal or gastroesophageal junction (GEJ) (tumors with epicenter 1 to 5 centimeters above the GEJ) carcinoma that is not amenable to surgical resection or definitive chemoradiation either: Cervical Cancer KEYTRUDA, in combination with chemoradiotherapy (CRT), is indicated for the treatment of patients with FIGO 2014 Stage III-IVA cervical cancer. KEYTRUDA, in combination with chemotherapy, with or without bevacizumab, is indicated for the treatment of patients with persistent, recurrent, or metastatic cervical cancer whose tumors express PD-L1 (CPS ≥1) as determined by an FDA-approved test. KEYTRUDA, as a single agent, is indicated for the treatment of patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy whose tumors express PD-L1 (CPS ≥1) as determined by an FDA-approved test. Hepatocellular Carcinoma KEYTRUDA is indicated for the treatment of patients with hepatocellular carcinoma (HCC) secondary to hepatitis B who have received prior systemic therapy other than a PD-1/PD-L1-containing regimen. Biliary Tract Cancer KEYTRUDA, in combination with gemcitabine and cisplatin, is indicated for the treatment of patients with locally advanced unresectable or metastatic biliary tract cancer (BTC). Merkel Cell Carcinoma KEYTRUDA is indicated for the treatment of adult and pediatric patients with recurrent locally advanced or metastatic Merkel cell carcinoma (MCC). Renal Cell Carcinoma KEYTRUDA, in combination with axitinib, is indicated for the first-line treatment of adult patients with advanced renal cell carcinoma (RCC). KEYTRUDA is indicated for the adjuvant treatment of patients with RCC at intermediate-high or high risk of recurrence following nephrectomy or following nephrectomy and resection of metastatic lesions. Endometrial Carcinoma KEYTRUDA, in combination with carboplatin and paclitaxel, followed by KEYTRUDA as a single agent, is indicated for the treatment of adult patients with primary advanced or recurrent endometrial carcinoma. KEYTRUDA, as a single agent, is indicated for the treatment of adult patients with advanced endometrial carcinoma that is MSI-H or dMMR, as determined by an FDA-approved test, who have disease progression following prior systemic therapy in any setting and are not candidates for curative surgery or radiation. Tumor Mutational Burden-High Cancer KEYTRUDA is indicated for the treatment of adult and pediatric patients with unresectable or metastatic tumor mutational burden-high (TMB-H) [≥10 mutations/megabase (mut/Mb)] solid tumors, as determined by an FDA-approved test, that have progressed following prior treatment and who have no satisfactory alternative treatment options. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials. The safety and effectiveness of KEYTRUDA in pediatric patients with TMB-H central nervous system cancers have not been established. Cutaneous Squamous Cell Carcinoma KEYTRUDA is indicated for the treatment of patients with recurrent or metastatic cutaneous squamous cell carcinoma (cSCC) or locally advanced cSCC that is not curable by surgery or radiation. Triple-Negative Breast Cancer KEYTRUDA is indicated for the treatment of patients with high-risk early-stage triple-negative breast cancer (TNBC) in combination with chemotherapy as neoadjuvant treatment, and then continued as a single agent as adjuvant treatment after surgery. KEYTRUDA, in combination with chemotherapy, is indicated for the treatment of patients with locally recurrent unresectable or metastatic TNBC whose tumors express PD-L1 (CPS ≥10) as determined by an FDA-approved test. Merck’s focus on cancer Every day, we follow the science as we work to discover innovations that can help patients, no matter what stage of cancer they have. As a leading oncology company, we are pursuing research where scientific opportunity and medical need converge, underpinned by our diverse pipeline of more than 25 novel mechanisms. With one of the largest clinical development programs across more than 30 tumor types, we strive to advance breakthrough science that will shape the future of oncology. By addressing barriers to clinical trial participation, screening and treatment, we work with urgency to reduce disparities and help ensure patients have access to high-quality cancer care. Our unwavering commitment is what will bring us closer to our goal of bringing life to more patients with cancer. For more information, visit https://www.merck.com/research/oncology . About Merck At Merck, known as MSD outside of the United States and Canada, we are unified around our purpose: We use the power of leading-edge science to save and improve lives around the world. For more than 130 years, we have brought hope to humanity through the development of important medicines and vaccines. We aspire to be the premier research-intensive biopharmaceutical company in the world – and today, we are at the forefront of research to deliver innovative health solutions that advance the prevention and treatment of diseases in people and animals. We foster a diverse and inclusive global workforce and operate responsibly every day to enable a safe, sustainable and healthy future for all people and communities. For more information, visit www.merck.com and connect with us on X (formerly Twitter) , Facebook , Instagram , YouTube and LinkedIn . SOURCE: Merck

Clinical ResultPhase 3Phase 2

26 Mar 2025

·www.prnewswire.com

ANNOUNCEMENT OF ANNUAL RESULTS FOR 2024

Notable Progress in R&D and Commercialization Gross Profit Surging 68% CHENGDU, China, March 26, 2025 /PRNewswire/ -- Sichuan Kelun-Biotech Pharmaceutical Co., Ltd. (" Kelun-Biotech" or the " Company", Stock Code: 6990.HK) announced its audited consolidated results for the year ended December 31, 2024 (the " Reporting Period"). In 2024, the pharmaceutical and healthcare sector experienced significant turbulence amid multiple internal and external shocks. China's biopharmaceutical industry continued to advance through transformation and breakthroughs, with factors such as pharmaceutical innovation, overseas expansion of innovative drugs, a "wave of M&A" in capital market, and the deepening of anti-corruption campaigns in healthcare collectively driving the industry toward steady recovery and innovative development. Adhering to its innovation-driven development strategy, the Company has consistently expanded into new targets, technologies, payloads, and therapeutic areas while continuously unlocking the clinical value of its core programs. From rapid advancement of key projects and sustained exploration of novel technologies to the steady establishment of a commercialization framework and the approval of three innovative drugs for market launch, the Company has achieved new breakthroughs in its "Pin(品)"-shaped strategic operational framework, with business progress yielding highly encouraging results. As of the latest update, the Company is actively developing over 30 drug candidates, including its core product sac-TMT (approved for marketing in China) as well as key products Tagitanlimab and Cetuximab N01. The Company has 11 ADC and novel DC assets at clinical stage or above, Through focused recognition of projects with competitive advantages and market value, along with strategic allocation of existing R&D resources to these prioritized programs, the Company's pipeline mainly consists of oncology drug candidates as well as drug candidates for non-oncology diseases and conditions such as autoimmune, metabolism and other disease areas. Core ADC Programs Advance Rapidly with Enhanced Value Across Innovative Pipeline Sac-TMT (sacituzumab tirumotecan, TROP2 ADC) (also known as SKB264/MK-2870) TNBC. In March 2024, sac-TMT was granted Breakthrough Therapy Designation by the NMPA for the first-line treatment of unresectable locally advanced, recurrent or metastatic PD-L1 negative TNBC. The Company has initiated a Phase 3 registrational study of sac-TMT monotherapy versus investigator-choice chemotherapy for 1L advanced TNBC. The results from the Phase 3 study of sac-TMT in patients with previously treated locally recurrent or metastatic TNBC were presented at the ASCO Annual Meeting in May 2024. Sac-TMT demonstrated a significant statistically and clinically meaningful improvement in PFS (HR: 0.32, representing a 68% reduction in disease progression risk) and OS (HR: 0.53, representing a 47% reduction in mortality risk). In November 2024, the Company received marking authorization in China from the NMPA for sac-TMT in adult patients with unresectable locally advanced or metastatic TNBC who have received at least two prior systemic therapies (at least one of them for advanced or metastatic setting). Sac-TMT is the first domestically developed ADC with global intellectual property rights to receive complete marketing authorization in China. HR+/HER2- BC. A Phase 3 registrational study for 2L+ HR+/HER2- locally advanced or metastatic BC is in progress. EGFR-mutant NSCLC. In October 2024, the NDA for sac-TMT for the treatment of adult patients with EGFR-mutant locally advanced or metastatic NSCLC who progressed after treatment with EGFR-TKI therapy was accepted by the NMPA and was included in the priority review and approval process. In March 2025, the Company received marketing authorization in China from the NMPA for sac-TMT for the treatment of adult patients with EGFR mutant-positive locally advanced or metastatic non-squamous NSCLC following progression on EGFR-TKI therapy and platinum-based chemotherapy. Compared with docetaxel, sac-TMT monotherapy demonstrated a statistically significant and clinically meaningful improvement in ORR, PFS and OS. In addition, a Phase 3 registrational study of sac-TMT combined with osimertinib as first-line treatment of locally advanced or metastatic non-squamous EGFR-mutant NSCLC is in progress. EGFR-wild type NSCLC. Two Phase 3 registrational studies of sac-TMT, namely sac-TMT in combination with pembrolizumab (KEYTRUDA®) versus pembrolizumab for first-line treatment of patients with PD-L1 positive locally advanced or metastatic NSCLC, and sac-TMT in combination with pembrolizumab versus chemotherapy combined with pembrolizumab as first-line treatment for patients with PD-L1 negative locally advanced or metastatic non-squamous NSCLC are in progress. T rastuzumab Botidotin (HER2 ADC, also known as A166) ( 舒泰萊 ®) In January 2025, an NDA for the treatment of adult patients with HER2+ unresectable or metastatic BC who have received at least one prior anti-HER2 therapy was accepted by the CDE of the NMPA. At a pre-specified interim analysis, trastuzumab botidotin monotherapy demonstrated a statistically significant and clinically meaningful improvement in the primary endpoint of PFS as assessed by the BICR compared with T-DM1. Trastuzumab botidotin has met the primary endpoints of its pivotal Phase 2 trial for 3L+ advanced HER2+ BC based on results from the primary analysis, which the Company used to submit an NDA to the NMPA. The Company has also initiated an open, multicenter Phase 2 clinical study of trastuzumab botidotin in the treatment of HER2+ unresectable or metastatic BC that previously received a topoisomerase inhibitor ADC. Other ADCs and Novel Conjugate Drugs SKB315 (CLDN18.2 ADC). SKB315 is configured with a proprietary, in-house developed humanized CLDN18.2 mAb and a differentiated payload-linker design. The early-stage clinical data of SKB315 demonstrates promising efficacy and acceptable safety profile in GC with mid and high CLDN18.2 expression. The Company is conducting a Phase 1b clinical trial of SKB315. SKB410/MK-3120 (Nectin-4 ADC). SKB410 is a novel Nectin-4 ADC targeting advanced solid tumors and utilizing a differentiated payload-linker strategy. SKB410 has shown promising Phase 1 clinical data. MSD, as the sponsor, has launched the global Phase 1/2 clinical trial of SKB410. SKB571/MK-2750. SKB571 is a novel bsADC that primarily targets various solid tumors such as LC and CRC etc. being developed in collaboration with MSD. The Phase 1 clinical trial in China is ongoing. SKB518, SKB535/MK-6204 and SKB445. SKB518, SKB535 and SKB445 are novel ADC drugs with potential FIC targets. The Phase 1 clinical trials for each of them are ongoing in China. The Company has entered into a license and collaboration agreement with MSD to develop SKB535. It was announced on the official website of the NMPA that SKB535 is the first pilot project approved by the NMPA through the optimized clinical trial review scheme for innovative drugs, and the review and approval time is 21 days. SKB500 and SKB501. SKB500 and SKB501 are novel ADC drugs with verified targets but differentiated payload-linker strategies. In November and December 2024, the Company received a clinical trial notice approving the IND application of SKB501 and SKB500, respectively, for advanced solid tumors from the NMPA. SKB107. SKB107 is an RDC drug jointly developed by us and the Affiliated Hospital of Southwest Medical University (西南醫科大學附屬醫院) targeting tumor bone metastasis. In January 2025, an IND application for SKB107 was accepted by the NMPA. Three I nnovative D rugs A pproved for M arket L aunch, M arking a S uccessful C ommercialization M ilestone for the P roduct P ipeline Currently, the Company has received marketing authorization for sac-TMT, tagitanlimab (科泰萊®) and Cetuximab N01 (達泰萊®) and has commenced their commercialization. The Company expects to launch trastuzumab botidotin (舒泰萊®) in the China market and file an NDA for A400 in 2025. Sacituzumab tirumotecan sac-TMT is a China's first domestically developed original TROP2 ADC targeting drug and the first domestically developed ADC to receive complete marketing authorization in China. It provides a novel and superior treatment pathway for Chinese patients with advanced triple-negative breast cancer (TNBC). Tagitanlimab (PD-L1 mAb, also known as A167) (科泰萊®) is the first PD-L1 mAb globally to receive authorization for the first-line treatment of NPC. In December 2024, the Company received marketing authorization of tagitanlimab in China from NMPA for the treatment of patients with recurrent or metastatic NPC who have failed after prior 2L+ chemotherapy. In January 2025, the Company received marketing authorization of tagitanlimab used in combination with cisplatin and gemcitabine for the first-line treatment of patients with recurrent or metastatic NPC in China from NMPA. Cetuximab N01 (EGFR mAb, also known as A140) (達泰萊®). In February 2025, the Company received marketing authorization in China from the NMPA for Cetuximab N01 Injection used in combination with FOLFOX or FOLFIRI regimens for first-line treatment of RAS wild-type mCRC. As demonstrated by a large-scale domestic Phase 3 clinical study conducting a head-to-head comparison of Cetuximab N01 Injection with Cetuximab Solution for Injection (Erbitux®), the Cetuximab N01 combination chemotherapy was clinical equivalent in ORR (Cetuximab N01 vs. Cetuximab Solution for Injection (Erbitux®): 71.0% vs. 77.5%; ORR ratio is 0.93 [95% CI: 0.87, 0.99]), and Cetuximab N01 did not demonstrate any clinically meaningful or statistically significant differences in DoR and PFS compared with Cetuximab Solution for Injection (Erbitux®) (median PFS: 10.9 months vs 10.8 months, HR: 1.03 [95% CI: 0.83, 1.28]; median DoR: 10.2 months vs. 9.5 months). As for safety, this study has sufficiently proven that the Cetuximab N01 combination chemotherapy is comparable in safety, tolerance and immunogenicity compared with Cetuximab Solution for Injection (Erbitux®) combination chemotherapy. The Company has set up a fully-fledged commercialization team to prepare and implement the marketing and commercialization of its strategic products and established a departmental structure within the Company, consisting of various departments such as Marketing, Commercial and Marketing Access, Medical Affairs, Sales, and Strategic Planning and Commercial Excellence. The Company will continue to refine our commercialization strategies for each late-stage drug candidate, first prioritizing therapeutic areas with medical needs in China, such as BC, NSCLC and GI cancers, while offering synergistic treatment options enabled by our diverse pipeline to optimize patient outcome. Globally, the Company will continue to pursue a flexible strategy to capture the commercial value in major international market, through forging synergistic license and collaboration opportunities worldwide. Steady Advancement in International Collaboration and Capital Management, with Continuous Refinement of ESG Governance Structure In 2024, the Company upheld its international development strategy and, in collaboration with MSD, promoted multi-dimensional, multi-level, and various forms of interaction and exchange to deepen their strategic partnership. MSD exercised its exclusive option for the SKB571, and several other collaborative pipelines received milestone payments from partners, marking a solid step forward in the cooperation. The Company has entered into license and collaboration agreements with MSD to develop multiple ADC assets for cancer treatment. The Company has granted MSD an exclusive, royalty-bearing and sub-licensable license to develop, use, manufacture and commercialize sac-TMT outside Greater China. The Company retains the right to develop and commercialize sac-TMT within Greater China. As of 4 March 2024, MSD has initiated 12 ongoing Phase3 global clinical studies of sac-TMT as amonotherapy or with pembrolizumab or other agents for several types of cancer. These studies are sponsored and led by MSD. The Company is also collaborating with MSD on several global Phase 2 basket studies for sac-TMT as monotherapy or in combination with other agents for multiple solid tumors and those studies are ongoing. In addition to sac-TMT, the Company is also collaborating with MSD on certain ADC assets including SKB410/MK-3120, SKB571/MK-2750, SKB535/MK-6204, etc. to continuously explore favorable ADC pipeline portfolios. In the third quarter of 2024, the Company was informed by MSD regarding an exclusive option to exercise SKB571/MK-2750. MSD has paid US$37.5 million to the Company in connection with the option to exercise, and the Company is eligible to receive further milestone payments conditional upon the achievement of specified development and sales milestones and tiered royalties on net sales of SKB571/MK-2750 if commercialized. Regarding the collaboration with Ellipses Pharma, in March 2024, it was announced that A400/EP0031 was granted Fast Track designation by the FDA for the treatment of RET-fusion positive NSCLC. In April 2024, A400 was cleared by the FDA to progress into Phase 2 clinical development. As of December 31, 2024, a total of 33 clinical sites in the United States, Europe and UAE were set up for A400/EP0031. Regarding the collaboration with Windward Bio, in January 2025, the Company and Harbour BioMed had entered into an exclusive license agreement with Windward Bio, under which the Company and Harbour BioMed granted Windward Bio an exclusive license for the research, development, manufacturing and commercialization of SKB378/WIN378 globally (excluding Greater China and several Southeast and West Asian countries). The Company has received upfront and milestone payments totaling US$147.5 million from partners with regard to multiple collaborated pipelines in 2024 and up to now. During the Reporting Period, the Company maintained a steady and disciplined approach to capital operations. It successfully completed a Hong Kong placement and domestic share issuance, raising US$150 million, providing strong and sustained momentum for its growth. Additionally, the Company continued to improve its ESG governance structure, issuing its first ESG report to reaffirm its commitment to environmental protection, social responsibility, and corporate governance, demonstrating its dedication as a publicly listed enterprise. In 2024, the Company was awarded "Excellence in ESG Governance Performance Award" by Ming Pao, and the Emerging Innovation Power Award from the China National Pharmaceutical Industry Information Center. Outlook In 2025, the Company will continue to deepen its R&D innovation reforms. By focusing on its core strengths, the Company aims to enhance efficiency, strengthen external collaborations, benchmark against the highest industry standards, and improve its scientific decision-making capabilities—thus maintaining and expanding its leading position in pioneering projects and key technology areas such as ADCs. Simultaneously, the Company will cultivate a product market-oriented mindset and, in response to unmet clinical needs, develop innovative drugs with differentiated advantages and international potential. Leveraging big data and artificial intelligence, the Company will further bolster its research capabilities in biology and translational medicine to improve the efficacy and success rate of innovative drug development. In addition, it will intensify international collaboration in innovative drugs, accelerate the cultivation of new competitive advantages, and integrate more deeply into the global innovative drug network to realize greater value for its innovations across broader market. About Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. (referred to as "Kelun-Biotech" Stock Code: 6990.HK) is a subsidiary of Sichuan Kelun Pharmaceutical Co., Ltd., specializing in the R&D, production, commercialization, and international collaboration of innovative biotechnology and small-molecule drugs. The Company focuses on addressing unmet clinical needs both globally and in China, with a strategic emphasis on major disease areas such as oncology, autoimmune disorders, inflammation, and metabolic diseases. It is dedicated to building an international platform for drug R&D and industrialization, with the aim of becoming a global leader in the innovative drug sector. Currently, Kelun-Biotech has over 30 key innovative drug projects, including 3 projects that have received market approval, 1 project at the NDA stage, and more than 10 projects in clinical trials. The Company has also successfully established its internationally renowned proprietary ADC development platform, OptiDCTM, with 1 ADC project approved for market launch, 1 ADC project at the NDA stage, and several ADC or novel ADC projects in clinical or preclinical development. For more information, please visit the official website: . SOURCE Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Phase 1Phase 3Phase 2Clinical ResultDrug Approval

19 Mar 2025

·www.drugs.com

Henlius Receives Orphan-Drug Designation for HLX22 (Innovative anti-HER2 mAb) in the U.S. for Gastric Cancer

Shanghai, China, March 19, 2025 - Shanghai Henlius Biotech, Inc. (2696.HK) announced that the US Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) for HLX22, the company's innovative anti-HER2 monoclonal antibody (mAb) for the treatment of gastric cancer. According to the US FDA, the drug or biological product receives an ODD will be eligible for certain development incentives, including but not limited to: 1) tax credits for clinical trial costs; 2) waiver of application fees for new drugs; and 3) seven years of market exclusivity without being affected by patent, aiming to accelerate the development process so that patients can benefit from the products as soon as possible. Receiving an Orphan Drug Designation for HLX22 recognizes its potential to treat patients with gastric cancer and marks another milestone for HLX22, following the initiation of its multicenter phase 3 clinical trials in multiple countries and regions worldwide, and signifies a crucial step forward in its global presence. Until now, gastric cancer still constitutes a major global health problem. According to GLOBOCAN 2022, there were around 1 million new cases and over 660 thousand new deaths of gastric cancer in 2022 globally [1] . Gastric cancer is often diagnosed at an advanced stage, with a poor prognosis and a 5-year relative survival rate of only 6% [2,3] . Despite significant advancements in targeted therapies, such as anti-HER2 agents, and immune checkpoint inhibitors (anti-PD-1/PD-L1 mAbs) for gastric cancer treatment in recent years [4] <, the disease's high molecular heterogeneity leads to markedly varied responses to chemotherapy, targeted therapy, and immunotherapy across different subtypes [5] . This underscores the urgent unmet clinical needs in the overall management of gastric cancer. HLX22, an innovative anti-HER2 mAb, can bind to HER2 extracellular subdomain IV at a binding site different from that of trastuzumab via differentiated molecular design and mechanism of action, which allows simultaneous binding of HLX22 and trastuzumab to HER2 dimers (HER2 homodimer and HER2/EGFR heterodimer) on tumour cell surface, thereby promoting the internalization and HER2 dimer degradation. The phase 2 clinical data on the combination of HLX22 and HANQUYOU (trastuzumab, trade name: HERCESSI™ in the U.S., Zercepac ® in Europe) demonstrate that the addition of HLX22 to trastuzumab plus chemotherapy significantly improves survival and anti-tumour efficacy in first-line treatment of HER2-positive gastric/gastroesophageal junction cancer (GC/GEJC) patients, with manageable safety profiles[6-8]，expected to redefine the first-line standard treatment for advanced gastric cancer. At present, the Investigational New Drug (IND) applications for HLX22-GC-301, a phase 3 clinical study aims to evaluate the efficacy and safety of HLX22 in combination with trastuzumab and chemotherapy for the first-line treatment of patients with HER2-positive metastatic GC/GEJC, have been approved in China, the U.S, Japan and Australia, etc. This international study has been initiated in multiple countries and regions worldwide and has completed its first patient dosing globally. Apart from its exploration in HER2-positive gastric cancer, the therapeutic scope of HLX22 has been further expanded to the field of breast cancer, potentially providing new treatment options for more patients. Looking forward, Henlius will adhere to patient-centricity, accelerating the multi-regional clinical trials of HLX22 to deliver this innovative therapy to patients worldwide. Meanwhile, the company will continue to delve into the oncology field, driving the development of more innovative therapeautics to provide high-quality and affordable treatment options. References [1] Bray F, Laversanne M, Sung H, et al. CA Cancer J Clin. 2024: 1-35. [2] Ajani JA. et al. J Natl Compr Canc Netw 2022;20(2):167-92. [3] Alsina M. et al. Nat Rev Gastroenterol Hepatol 2023;20(3):155-70. [4] Miao, ZF.,et al. Progress and remaining challenges in comprehensive gastric cancer treatment. Holist Integ Oncol 1, 4 (2022). [5] Guan, WL.,et al. Gastric cancer treatment: recent progress and future perspectives. J Hematol Oncol 16, 57 (2023). [6] Jin Li et al., HLX22 plus HLX02 and XELOX for first-line treatment of HER2-positive locally advanced or metastatic gastric/gastroesophageal junction cancer: A randomized, double-blind, multicenter phase 2 study.. JCO 42, 354-354(2024).DOI:10.1200/JCO.2024.42.3_suppl.354 [7] J. Li et al., 422P HLX22 plus HLX02 and XELOX as first-line therapy for HER2-positive advanced gastric/gastroesophageal junction cancer: Updated results from a randomized, double-blind phase II study, Annals of Oncology,Annals of Oncology (2024) 35 (suppl_1): S162-S204. 10.1016/annonc/annonc1482 [8] Li N, et al. A randomized phase 2 study of HLX22 plus trastuzumab biosimilar HLX02 and XELOX as first-line therapy for HER2-positive advanced gastric cancer. Med. 2024;5(10):1255-1265.e2. Source: Shanghai Henlius Biotech, Inc. 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Phase 2ImmunotherapyOrphan DrugDrug ApprovalPhase 3

100 Deals associated with Trastuzumab

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KEGG	Wiki	ATC	Drug Bank
D03257	Trastuzumab	L01XC03	DB00072

R&D Status

Approved

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Indication	Country/Location	Organization	Date
HER2 Positive Colorectal Cancer	Japan	Chugai Pharmaceutical Co., Ltd.	28 Mar 2022
HER2 positive salivary gland cancer	Japan	Chugai Pharmaceutical Co., Ltd.	25 Nov 2021
HER2-positive gastric cancer	Japan	Chugai Pharmaceutical Co., Ltd.	10 Mar 2011
Stomach Cancer	United States	Genentech, Inc.	20 Oct 2010
Breast Cancer	Japan	Chugai Pharmaceutical Co., Ltd.	04 Apr 2001
Early Stage Breast Carcinoma	European Union	Roche Registration GmbH	28 Aug 2000
Early Stage Breast Carcinoma	Iceland	Roche Registration GmbH	28 Aug 2000
Early Stage Breast Carcinoma	Liechtenstein	Roche Registration GmbH	28 Aug 2000
Early Stage Breast Carcinoma	Norway	Roche Registration GmbH	28 Aug 2000
HER2 Positive Breast Cancer	European Union	Roche Registration GmbH	28 Aug 2000
HER2 Positive Breast Cancer	Iceland	Roche Registration GmbH	28 Aug 2000
HER2 Positive Breast Cancer	Liechtenstein	Roche Registration GmbH	28 Aug 2000
HER2 Positive Breast Cancer	Norway	Roche Registration GmbH	28 Aug 2000
HER2 positive Gastroesophageal Junction Adenocarcinoma	European Union	Roche Registration GmbH	28 Aug 2000
HER2 positive Gastroesophageal Junction Adenocarcinoma	Iceland	Roche Registration GmbH	28 Aug 2000
HER2 positive Gastroesophageal Junction Adenocarcinoma	Liechtenstein	Roche Registration GmbH	28 Aug 2000
HER2 positive Gastroesophageal Junction Adenocarcinoma	Norway	Roche Registration GmbH	28 Aug 2000
Metastatic Gastric Carcinoma	European Union	Roche Registration GmbH	28 Aug 2000
Metastatic Gastric Carcinoma	Iceland	Roche Registration GmbH	28 Aug 2000
Metastatic Gastric Carcinoma	Liechtenstein	Roche Registration GmbH	28 Aug 2000

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Bladder Cancer	Phase 3	United Kingdom	Hoffmann-La Roche, Inc.	07 Mar 2023
Colorectal Cancer	Phase 3	United Kingdom	Hoffmann-La Roche, Inc.	07 Mar 2023
Gallbladder Neoplasms	Phase 3	United Kingdom	Hoffmann-La Roche, Inc.	07 Mar 2023
Hematologic Neoplasms	Phase 3	United Kingdom	Hoffmann-La Roche, Inc.	07 Mar 2023
Lung Cancer	Phase 3	United Kingdom	Hoffmann-La Roche, Inc.	07 Mar 2023
Ovarian Cancer	Phase 3	United Kingdom	Hoffmann-La Roche, Inc.	07 Mar 2023
Pancreatic Cancer	Phase 3	United Kingdom	Hoffmann-La Roche, Inc.	07 Mar 2023
Prostatic Cancer	Phase 3	United Kingdom	Hoffmann-La Roche, Inc.	07 Mar 2023
Salivary Gland Neoplasms	Phase 3	United Kingdom	Hoffmann-La Roche, Inc.	07 Mar 2023
Skin Neoplasms	Phase 3	United Kingdom	Hoffmann-La Roche, Inc.	07 Mar 2023

Clinical Result

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT01897441 (CTgov)	Not Applicable	Metastatic breast cancer \| Breast Cancer 3 \| Advanced breast cancer	31	Cytology Specimen Collection Procedure+Trastuzumab+Doxorubicin Hydrochloride+cyclophosphamide+Paclitaxel (Stratum A: HER2-positive)	rvjcdtiapt(wnjcedcayx) = zsnrbsaenu odoxpsffnm (cqzxtkggxh, kdltvrbjvs - cdxvxuynbs) View more	-	25 Mar 2025
				Cytology Specimen Collection Procedure+Doxorubicin Hydrochloride+cyclophosphamide+Paclitaxel (Stratum B: HER2-negative)	rvjcdtiapt(wnjcedcayx) = xtjwprsrha odoxpsffnm (cqzxtkggxh, ldtoljvnji - ssbxsddowa) View more
JPRN-jRCTs031180006 (JCOG1301C \| Trigger, ASCO_GI2025) Manual	Phase 2	HER2-positive gastric cancer \| HER2 positive Gastroesophageal Junction Adenocarcinoma Adjuvant HER2 Positive	46	S-1/cisplatin	ghltwuwrxa(tazikoepor) = gwnwprugpa lypiwsssxg (ermxpkweyh ) View more	Positive	23 Jan 2025
				S-1/cisplatin + Trastuzumab	ghltwuwrxa(tazikoepor) = xeemrtazss lypiwsssxg (ermxpkweyh ) View more
NCT02205047 (INNOVATION, ASCO_GI2025) Manual	Phase 2	HER2-positive gastric cancer HER2 Positive	172	Chemotherapy alone	bglpidlytz(pqzmndwvlh) = sjmjhjuhrz ecmdcdvffs (fuufrvrmpc ) View more	Negative	23 Jan 2025
				Chemotherapy + Trastuzumab	bglpidlytz(pqzmndwvlh) = vzfoldohbk ecmdcdvffs (fuufrvrmpc ) View more
NCT05002127 (ASPEN-06, ASCO_GI2025) Manual	Phase 2/3	HER2 Positive Gastroesophageal Adenocarcinoma \| HER2-positive gastric cancer HER2+	127	EvorpaceptEvorpacept (ALX148) + Trastuzumab (T) + Ramucirumab (R) + Paclitaxel (P)	dwnjxarylv(wrhicbwmej) = rlxjazsqlv wswngrkbzc (xsdsuummzz ) View more	Positive	23 Jan 2025
				Trastuzumab (T) + Ramucirumab (R) + Paclitaxel (P)	dwnjxarylv(wrhicbwmej) = phzzkzlcvk wswngrkbzc (xsdsuummzz ) View more
NCT04579380 (SGNTUC-019, Pubmed \| Nat Med) Manual	Phase 2	Metastatic breast cancer HER2 Positive	31	Tucatinib + Trastuzumab	truxkofqmk(ohdzgedzah) = wtcfeozuqu acpofxsujt (fjoornbgkw, 26.9 - 58.2) View more	Positive	17 Jan 2025
NCT03365882 (S1613, Pubmed) Manual	Phase 2	RAS/BRAF Wild Type HER2 Positive Colorectal Cancer Second line \| Third line HER2 Positive	54	Trastuzumab plus Pertuzumab	gqmxcjvalz(uizljvzarp) = lgobpilsot yiclrptrsr (zrmkuujsbk, 1.9 - 7.6) View more	Positive	06 Jan 2025
				Cetuximab plus Irinotecan	gqmxcjvalz(uizljvzarp) = tzunoneaqs yiclrptrsr (zrmkuujsbk, 1.6 - 6.7) View more
ESMO_IO2024 Manual	Phase 2	Advanced gastric carcinoma \| Advanced Gastroesophageal Junction Adenocarcinoma First line	19	Cadonilimab+SOX (HER2-negative)	eqtkqdmrki(zaxwrthndb) = hhevcgujmu apmbbfszgb (eiifrfuiyc ) View more	Positive	12 Dec 2024
				Cadonilimab+Trastuzumab+SOX (HER2-positive)	eqtkqdmrki(zaxwrthndb) = tzyfhgdhsk apmbbfszgb (eiifrfuiyc ) View more
NCT05659056 (SABCS2024) Manual	Phase 2	HER2 Positive Breast Cancer Neoadjuvant HER2 Positive	52	pyrotinib + trastuzumab + nab-paclitaxel	xkvssqazti(glhmlknpax) = ovrecztzwe gmueusndaf (ojbudiyait, 29.0 - 56.7) View more	Positive	10 Dec 2024
				pyrotinib + trastuzumab + nab-paclitaxel (HER2-enriched subtype)	xkvssqazti(glhmlknpax) = kuuuupeetl gmueusndaf (ojbudiyait, 37.9 - 73.2)
NCT05275010 (CTgov)	Phase 1	-	151	Handheld Syringe+Fixed-Dose Combination of Pertuzumab and Trastuzumab SC (Arm 1: PH FDC SC Using a Handheld Syringe)	wuawisvhik(cpgjqqmspn) = nculbsolgy yybsnmmiot (lwbawjlklc, 27.5) View more	-	23 Sep 2024
				On-Body Delivery System (Arm 2: PH FDC SC Using the OBDS)	wuawisvhik(cpgjqqmspn) = bbncebtfsp yybsnmmiot (lwbawjlklc, 23.2) View more
ACTRN12620000767909 (ESMO2024) Manual	Phase 2	HER2 Positive Cancer ERBB2 Amplification \| ERBB2 Mutation (Activating)	31	Tucatinib trastuzumabumab	spifpikchy(trlrykxckn) = ylaasynvke ntpkjuzdce (wgxsbtzttx ) View more	Positive	14 Sep 2024
				Tucatinibtrastuzumab	spifpikchy(trlrykxckn) = aratlcjsoc ntpkjuzdce (wgxsbtzttx ) View more

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