Classical Hodgkin's Lymphoma

KEYNOTE-689 marks the first positive trial in more than two decades for patients with resected locally advanced head and neck squamous cell carcinoma (LA-HNSCC) Results to be presented at American Association for Cancer Research (AACR) Annual Meeting 2025 during a Plenary Session and included in official meeting press program RAHWAY, NJ, USA I April 27, 2025 I Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced results from the Phase 3 KEYNOTE-689 trial evaluating KEYTRUDA ® (pembrolizumab), Merck’s anti-PD-1 therapy, as a perioperative treatment regimen for patients with stage III or IVA, resected, locally advanced head and neck squamous cell carcinoma (LA-HNSCC). Results at the first interim analysis of the trial showed KEYTRUDA significantly improved event-free survival (EFS) as part of a perioperative treatment regimen with adjuvant standard of care (SOC) radiotherapy with or without cisplatin compared to adjuvant standard of care (SOC) radiotherapy with or without cisplatin alone in patients with resectable LA-HNSCC. These data are being presented for the first time today during a Plenary Session at the American Association for Cancer Research (AACR) Annual Meeting 2025 (Abstract #CT001) and were selected for the AACR press program. After a median follow-up of 38.3 months (range, 9.0-66.5), treatment with KEYTRUDA before surgery (neoadjuvant), then continued in combination with standard of care radiotherapy (with or without cisplatin) after surgery followed by KEYTRUDA alone (adjuvant), reduced the risk of EFS events by 34% (HR=0.66 [95% CI, 0.49-0.88]; p=.0022) in the combined positive score (CPS) ≥10 population, by 30% (HR=0.70 [95% CI, 0.55-0.89; p=.0014) in the CPS ≥1 population and by 27% (HR=0.73 [95% CI 0.58-0.92]; p=.0041) in the intent-to-treat (ITT) population, compared to adjuvant radiotherapy (with or without cisplatin) alone in the ITT population. Among the CPS ≥10 population, median EFS was 59.7 months in the KEYTRUDA plus SOC group (95% CI, 41.1-not reached) versus 26.9 months (95% CI, 18.3-51.5) in the SOC group. Among the CPS ≥1 population, median EFS was 59.7 months (95% CI, 37.9-not reached) in the KEYTRUDA plus SOC group versus 29.6 months (95% CI, 19.5-41.9) in the SOC group. In the ITT population, median EFS was 51.8 months (95% CI, 37.5-not reached) in the KEYTRUDA plus SOC group versus 30.4 months (95% CI, 21.8-50.1) in the SOC group. The safety profile of KEYTRUDA was consistent with that observed in previously reported studies; no new safety signals were identified. “As the first positive trial in over two decades for patients with resectable, locally advanced head and neck squamous cell carcinoma, the presentation of these landmark results marks an important moment for these patients and those who care for them,” said Dr. Ravindra Uppaluri, the study’s co-principal investigator, director of Head and Neck Surgical Oncology, Brigham and Women’s Hospital and Dana-Farber Cancer Institute. “KEYNOTE-689 represents a meaningful development with a potential to provide an option that helps certain patients with LA-HNSCC reduce the risk of recurrence and disease progression earlier in their treatment journey.” “The addition of immunotherapy using KEYTRUDA to standard of care surgery and adjuvant (chemo)radiotherapy resulted in a significant reduction in the risk of event-free survival events by 27%, compared with standard of care therapy alone,” said study co-principal investigator Dr. Douglas Adkins, Professor, Division of Oncology, Washington University School of Medicine in St. Louis. “These results are notable as they mark the first time an anti-PD-1 therapy has demonstrated a statistically significant and clinically meaningful improvement in event-free survival in the neoadjuvant and adjuvant setting in earlier stages of head and neck squamous cell carcinoma.” The study also showed a statistically significant improvement in major pathological response (mPR) rate, a key secondary endpoint, in patients with CPS ≥10 (difference in mPR rates: 13.7% [95% CI, 9.7-18.7]; p<0.00001), CPS ≥1 (9.8% [95% CI, 7.0-13.3]; p<0.00001) and in the ITT population (9.3% [95% CI, 6.7–12.8, P<.00001), compared to adjuvant radiotherapy alone. A trend toward improvement in overall survival (OS), another key secondary endpoint, was observed in patients with CPS ≥10 (HR=0.72 [95% CI, 0.52-0.98])at the time of this interim analysis for the KEYTRUDA plus standard of care regimen versus standard of care alone. The OS results did not reach statistical significance at the time of this interim analysis. Due to the statistical testing hierarchy, formal testing was not performed in the CPS ≥1 and ITT populations. OS will be evaluated at the next interim analysis. “As the 12 th positive pivotal trial for a KEYTRUDA-based regimen in earlier-stage cancers, the results from KEYNOTE-689 are a testament to our commitment to address an unmet need in this important area of research,” said Dr. Marjorie Green, senior vice president and head of oncology, global clinical development, Merck Research Laboratories. “These compelling results illustrate the potential of this regimen to change the landscape of care for certain patients facing this challenging disease. We are working with the FDA and other global authorities to bring this new option to patients as quickly as possible.” A supplemental Biologics License Application (sBLA) for KEYTRUDA based on data from KEYNOTE-689 is under priority review with the U.S. Food and Drug Administration (FDA), with a Prescription Drug User Fee Act (PDUFA), or target action, date of June 23, 2025. KEYTRUDA is currently approved as monotherapy and in combination regimens for appropriate patients with metastatic or unresectable, recurrent HNSCC in the U.S., Europe, China, Japan and other countries around the world. For more information, please see the “Selected KEYTRUDA ® (pembrolizumab) Indications in the U.S.” section below. Study design and additional data from KEYNOTE-689 KEYNOTE-689 is a randomized, active-controlled, open-label Phase 3 trial (ClinicalTrials.gov, NCT03765918 ) evaluating KEYTRUDA as neoadjuvant treatment and KEYTRUDA in combination with standard of care radiotherapy (with or without cisplatin) as adjuvant treatment in treatment-naïve patients with newly diagnosed, stage III or IVA resectable, locally advanced head and neck squamous cell carcinoma (LA-HNSCC). Efficacy outcomes are classified by programmed cell death ligand 1 (PD-L1) combined positive score (CPS) status. The primary endpoint is EFS, which is defined as the time from randomization to the first occurrence of radiographic disease progression; local or distant progression or recurrence; or death due to any cause. The secondary endpoints include OS, mPR, pathological complete response and safety. The study enrolled 714 patients who were randomized 1:1 to receive: The safety profile of KEYTRUDA was consistent with that observed in previously reported studies. Grade ≥3 treatment-related adverse events (TRAEs) occurred in 44.6% of patients receiving KEYTRUDA plus standard of care radiotherapy versus 42.9% of patients receiving standard of care radiotherapy alone. TRAEs led to death in 1.1% of patients receiving the KEYTRUDA regimen (n=4) and 0.3% of patients receiving standard of care radiotherapy (n=1). No new safety concerns were identified. Immune-mediated adverse events (AEs) of any grade occurred in 43.2% of patients receiving the KEYTRUDA regimen, most commonly hypothyroidism (24.7%). About head and neck cancer Head and neck cancer describes a number of different tumors that develop in or around the throat, larynx, nose, sinuses and mouth. Most head and neck cancers are squamous cell carcinomas that begin in the flat, squamous cells that make up the thin surface layer of the structures in the head and neck. Locally advanced head and neck squamous cell carcinoma (LA-HNSCC) is cancer that has grown outside the original location, but has not yet spread to distant parts of the body. There are several factors that greatly increase the risk of developing head and neck cancer, including tobacco and alcohol use and human papillomavirus (HPV). It is estimated there were more than 947,200 new cases of head and neck cancer diagnosed and over 482,400 deaths from the disease in 2022 globally. In the U.S., it is estimated there will be approximately 72,680 new cases of head and neck cancer diagnosed and more than 16,680 deaths from the disease in 2025. About Merck’s early-stage cancer clinical program Finding cancer at an earlier stage may give patients a greater chance of long-term survival. Many cancers are considered most treatable and potentially curable in their earliest stage of disease. Building on the strong understanding of the role of KEYTRUDA in later-stage cancers, Merck is evaluating our portfolio of medicines and pipeline candidates in earlier disease states, with more than 30 ongoing registrational studies across multiple types of cancer. About KEYTRUDA ® (pembrolizumab) injection, 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. 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. 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. 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. 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). 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. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval of this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials. 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 http://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

SAN FRANCISCO and SUZHOU,China, April 23, 2025 /PRNewswire/ -- Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high quality medicines for the treatment of oncology, cardiovascular and metabolic, autoimmune, ophthalmology and other major diseases, announces that clinical data for its innovative bispecific antibodies and ADC molecules, including oral presentations for IBI363 (PD-1/IL-2α-bias) and IBI343 (CLDN18.2 ADC), will be presented at the American Society of Clinical Oncology (ASCO) Annual Meeting 2025 from May 30 to June 3, 2024, in Chicago, Illinois, U.S. Dr. Hui Zhou, Senior Vice President of Innovent, stated: "We are delighted to announce that at 2025 ASCO Annual Meeting, the first wave of three indications under development for IBI363—melanoma, colorectal cancer(CRC), and non-small cell lung cancer (NSCLC)—have all been accepted for oral presentations, highlighting the significant attention garnered by the next-generation bispecific antibodies, in particular PD-1-based immunotherapy. Additionally, following its oral presentation at ESMO Asia last December, the Phase 1b data of IBI343 in pancreatic cancer has once again secured an oral presentation at ASCO, further solidifying its potential in this challenging therapeutic area. The maturing PoC data for these innovative candidates has strengthened our confidence in advancing them into pivotal-stage development, with the goal of unlocking their clinical value for global unmet clinical needs. As one of the few biopharmaceutical companies with both the advanced technology platforms and robust pipeline in "IO+ADC" areas, Innovent will continue to make breakthroughs in the field of cancer treatment, and is committed to providing physicians and patients with more innovative, effective and safe treatment options." Details on the abstracts are listed below: Oral Presentation 1. Presentation Title: Efficacy and safety results of a first-in-class PD-1/IL-2α-bias bispecific antibody fusion protein, IBI363, in patients with immunotherapy-treated, advanced acral and mucosal melanoma Abstract Number: 2502 Session Type: Oral Abstract Session Title: Developmental Therapeutics-Immunotherapy Session Date & Time: 5/31/2025 3:00 PM-6:00 PM CDT Presenter: Jun Guo, MD, Beijing Cancer Hospital 2. Presentation Title: Efficacy and safety of IBI363 monotherapy or in combination with bevacizumab in patients with advanced colorectal cancer Abstract Number: 104 Session Type: Oral Abstract Session Title: Clinical Science Symposium—Turning "Cold" Tumors "Hot" Session Date & Time: 6/1/2025 9:45 AM-11:15 AM CDT Presenter: Zhenyu Lin, MD, Cancer Center, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology 3. Presentation Title: First-in-class PD-1/IL-2α-bias bispecific antibody, IBI363, in patients with advanced immunotherapy-treated non-small cell lung cancer (NSCLC) Abstract Number: 8509 Session Type: Oral Abstract Session Title: Clinical Science Symposium—Two Targets, One Goal: The Potential for Bispecific Antibodies in Thoracic Malignancies Session Date & Time: 6/3/2025 9:45 AM-11:15 AM CDT Presenter: Jianya Zhou, MD, The First Affiliated Hospital, Zhejiang University School of Medicine 4. Presentation Title: Claudin18.2 (CLDN18.2) expression and efficacy in pancreatic ductal adenocarcinoma (PDAC): results from a Phase 1 dose expansion cohort evaluating IBI343 Abstract Number: 4017 Session Type: Rapid Oral Abstract Session Title: Gastrointestinal Cancer—Gastroesophageal, Pancreatic, and Hepatobiliary Session Date & Time: 6/2/2025 11:30 AM-1:00 PM CDT Presenter: Xianjun Yu, MD, Fudan University Shanghai Cancer Center 5. Presentation Title: Sintilimab (anti-PD-1) plus ifosfamide, carboplatin and etoposide (ICE) in second-line classical Hodgkin lymphoma (cHL): Results of a multicenter, randomized, controlled, double-blind Phase 3 study (ORIENT-21) Abstract Number: 7007 Session Type: Oral Abstract Session Title: Hematologic Malignancies—Lymphoma and Chronic Lymphocytic Leukemia Session Date & Time: 5/30/2025 2:45 PM-5:45 PM CDT Presenter: Peng Liu,MD, Cancer Hospital, Chinese Academy of Medical Sciences 6. Presentation Title: Short-course radiotherapy followed by sintilimab and CAPOX as total neoadjuvant treatment in locally advanced rectal cancer: A prospective, randomized controlled trial (SPRING-01) Abstract Number: 3519 Session Type: Rapid Oral Abstract Session Title: Gastrointestinal Cancer-Colorectal and Anal Session Date & Time: 6/1/2025 11:30 AM-1:00 PM CDT Presenter：Changqing Jing, MD, Shandong Provincial Hospital 7. Presentation Title: Dynamic circulating tumor DNA-driven, risk-adapted systematic therapy in n as opharyngeal carcinoma: The EP-STAR trial Abstract Number: 6010 Session Type: Oral Abstract Session Title: Clinical Science Symposium -Biomarker-Driven Adaptive Therapy: New Horizons in Head and Neck Cancer Session Date & Time: 6/2/2025 3:00 PM-4:30 PM CDT Presenter: Ying Sun, MD, Sun Yat-sen University Cancer Center Poster Presentation 1. Presentation Title: A multicenter, randomized, controlled, open-label, Phase 2 study of the PD-1/IL-2α-bias bispecific antibody fusion protein IBI363 in mucosal and acral melanoma: Trial in Progress Abstract Number: TPS9594 Session Type: Poster Session Title: Melanoma/Skin Cancers Session Date & Time: 6/1/2025 9:00 AM-12:00 PM CDT Presenter: Bin Lian, MD, Peking University Cancer Hospital & Institute 2. Presentation Title: IBI354, an anti-HER2 antibody-drug conjugate, in patients with locally advanced unresectable or metastatic ovarian cancers: updated results from a Phase 1 trial Abstract Number: 5565 Session Type: Poster Session Title: Gynecologic Cancer Session Date & Time: 6/1/2025 9:00 AM-12:00 PM CDT Presenter: Jin Shu, MD, Chongqing University Cancer Hospital 3. Presentation Title: IBI354 (anti-HER2 antibody-drug conjugate [ADC]) in patients with HER2-positive breast cancer (BC) and other solid tumors: Updates from a Phase 1 study Abstract Number: 1029 Session Type: Poster Session Title: Breast Cancer—Metastatic Session Date & Time: 6/2/2025 9:00 AM-12:00 PM CDT Presenter: Charlotte Rose Lemech, BSc, FRACP, MBBS , Scientia Clinical Research 4. Presentation Title: Safety and efficacy of the anti-TROP2 antibody-drug conjugate (ADC) IBI130 in patients with advanced triple-negative breast cancer (TNBC) and other solid tumors: Results from the Phase 1 study Abstract Number: 1102 Session Type: Poster Session Title: Breast Cancer—Metastatic Session Date & Time: 6/2/2025 9:00 AM-12:00 PM CDT Presenter: Fan Wu, MD, Fujian Cancer Hospital 5. Presentation Title: A multiregional, randomized, controlled, open-label, Phase 3 study of the anti-claudin18.2 (CLDN18.2) antibody-drug conjugate (ADC) arcotatug tavatecan (IBI343) in gastric or gastroesophageal junction adenocarcinoma (G/GEJA): Trial in Progress Abstract Number: TPS4201 Session Type: Poster Session Title: Gastrointestinal Cancer—Gastroesophageal, Pancreatic, and Hepatobiliary Session Date & Time: 5/31/2025 9:00 AM-12:00 PM CDT Presenter: Lin Shen, MD, Beijing Cancer Hospital 6. Presentation Title: Phase 2 trial of transarterial chemoembolization followed by sintilimab (anti-PD-1), oxaliplatin, and S-1 combined with either trastuzumab (HER-2 positive) or apatinib (HER-2 negative) as first-line therapy for gastric cancer with liver metastases. Abstract Number: 4050 Session Type: Poster Session Title: Gastrointestinal Cancer-Gastroesophageal, Pancreatic, and Hepatobiliary Session Date & Time: 5/31/2025 9:00 AM-12:00 PM CDT Presenter: Dan Sha, MD, Shandong Provincial Hospital *Abstracts of TYVYT ®(sintilimab) are from investigator-initiated clinical trials (IIT), except one abstract, #7007. About Innovent Innovent is a leading biopharmaceutical company founded in 2011 with the mission to empower patients worldwide with affordable, high-quality biopharmaceuticals. The company discovers, develops, manufactures and commercializes innovative medicines that target some of the most intractable diseases. Its pioneering therapies treat cancer, cardiovascular and metabolic, autoimmune and eye diseases. Innovent has launched 15 products in the market. It has 3 new drug applications under regulatory review, 4 assets in Phase III or pivotal clinical trials and 15 more molecules in early clinical stage. Innovent partners with over 30 global healthcare companies, including Eli Lilly, Sanofi, Incyte, Adimab, LG Chem and MD Anderson Cancer Center. Guided by the motto, "Start with Integrity, Succeed through Action," Innovent maintains the highest standard of industry practices and works collaboratively to advance the biopharmaceutical industry so that first-rate pharmaceutical drugs can become widely accessible. For more information, visit , or follow Innovent on Facebook and LinkedIn. Statement: (1) Innovent does not recommend the use of any unapproved drug (s)/indication (s). (2) Ramucirumab (Cyramza) and Selpercatinib (Retsevmo) and Pirtobrutinib (Jaypirca) were developed by Eli Lilly and Company. Forward-looking statement This news release may contain certain forward-looking statements that are, by their nature, subject to significant risks and uncertainties. The words "anticipate", "believe", "estimate", "expect", "intend" and similar expressions, as they relate to Innovent Biologics ("Innovent"), are intended to identify certain of such forward-looking statements. The Company does not intend to update these forward-looking statements regularly. These forward-looking statements are based on the existing beliefs, assumptions, expectations, estimates, projections and understandings of the management of the Company with respect to future events at the time these statements are made. These statements are not a guarantee of future developments and are subject to risks, uncertainties and other factors, some of which are beyond the Company's control and are difficult to predict. Consequently, actual results may differ materially from information contained in the forward-looking statements as a result of future changes or developments in our business, the Company's competitive environment and political, economic, legal and social conditions. The Company, the Directors and the employees of the Company assume (a) no obligation to correct or update the forward-looking statements contained in this site; and (b) no liability in the event that any of the forward-looking statements does not materialise or turn out to be incorrect. SOURCE Innovent Biologics WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

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