Studies have indicated that the improvement in pathological complete response (pCR) is significantly correlated with luminal breast cancer patients' overall survival (OS). Patients with luminal breast cancer have poor efficacy for neoadjuvant chemotherapy. The combination of neoadjuvant therapy with immunotherapy and chemotherapy has been demonstrated to enhance the pCR rate of luminal-type breast cancer patients, increasing it from 13-15% to approximately 24%. Therefore, how to further improve the pCR rate of luminal-type breast cancer became the main objective of this study. Stereotactic radiotherapy (SBRT) not only kills tumor cells directly, but also kills the distant unirradiated tumor cells by promoting the cross-initiation of tumor-specific CD8+ T cells, a phenomenon known as the abscopal effect. Our research team has recently discovered that the triple therapy model of SBRT + anti-vascular targeting + anti-PD-1 was safe and efficacious in lung cancer patients. Ivonescimab (AK112) is an anti-PD-1/VEGF-A bispecific antibody. In order to improve the pCR, a single-arm, open, phase II clinical study was proposed to explore the safety and efficacy of SBRT+AK112+chemotherapy, a neoadjuvant treatment modality, in the treatment of luminal breast cancer.

Start Date01 Sep 2024

Sponsor / Collaborator

Hubei Cancer Hospital

NCT06444009 / Not yet recruitingPhase 2IIT

Neoadjuvant Immunotherapy in Combination With Chemotherapy in Resectable Head and Neck Cancer：A Randomized, Phase II Study

A Randomized, Phase II Study of ivonescimab or cadonilimab or penpulimab in Combination With Cisplatin and Nab-paclitaxel in Patients With III-IVB (according to the 8th edition of UICC/AJCC staging) locally advanced head and neck squamous cell carcinoma (HNSCC) eligible for resection. This proposed study will evaluate the efficacy and safety of preoperative administration of ivonescimab or cadonilimab or penpulimab combined with chemotherapy in HNSCC who are eligible for resection.

Start Date01 Jun 2024

Sponsor / Collaborator

West China Hospital

NCT06424626 / Not yet recruitingPhase 1IIT

A Phase Ib, Open, Mono-center, Dose-reduction Tolerability Study of AK104 or AK112 in Combination With Axitinib in Patients With Metastatic Mucosal Melanoma

This study was a phase IB, single-center, open-label, two part(part A involved dose reduction, and part B involved cohort expansion) clinical trial evaluating the safety and clinical activity of AK104 or AK112 in combination with axitinib in patients with advanced mucosal melanoma.

Start Date21 May 2024

Sponsor / Collaborator-

100 Clinical Results associated with Ivonescimab

100 Translational Medicine associated with Ivonescimab

100 Patents (Medical) associated with Ivonescimab

Literatures (Medical) associated with Ivonescimab

31 Dec 2024·mAbs

Antibodies to watch in 2024

Article

Author: Reichert, Janice M ; Crescioli, Silvia ; Kaplon, Hélène ; Wang, Lin ; Visweswaraiah, Jyothsna ; Chenoweth, Alicia

The 'Antibodies to Watch' article series provides an annual summary of commercially sponsored monoclonal antibody therapeutics currently in late-stage clinical development, regulatory review, and those recently granted a first approval in any country. In this installment, we discuss key details for 16 antibody therapeutics granted a first approval in 2023, as of November 17 (lecanemab (Leqembi), rozanolixizumab (RYSTIGGO), pozelimab (VEOPOZ), mirikizumab (Omvoh), talquetamab (Talvey), elranatamab (Elrexfio), epcoritamab (EPKINLY), glofitamab (COLUMVI), retifanlimab (Zynyz), concizumab (Alhemo), lebrikizumab (EBGLYSS), tafolecimab (SINTBILO), narlumosbart (Jinlitai), zuberitamab (Enrexib), adebrelimab (Arelili), and divozilimab (Ivlizi)). We briefly review 26 product candidates for which marketing applications are under consideration in at least one country or region, and 23 investigational antibody therapeutics that are forecast to enter regulatory review by the end of 2024 based on company disclosures. These nearly 50 product candidates include numerous innovative bispecific antibodies, such as odronextamab, ivonescimab, linvoseltamab, zenocutuzumab, and erfonrilimab, and antibody-drug conjugates, such as trastuzumab botidotin, patritumab deruxtecan, datopotamab deruxtecan, and MRG002, as well as a mixture of two immunocytokines (bifikafusp alfa and onfekafusp alfa). We also discuss clinical phase transition and overall approval success rates for antibody therapeutics, which are crucial to the biopharmaceutical industry because these rates inform decisions about resource allocation. Our analyses indicate that these molecules have approval success rates in the range of 14-32%, with higher rates associated with antibodies developed for non-cancer indications. Overall, our data suggest that antibody therapeutic development efforts by the biopharmaceutical industry are robust and increasingly successful.

01 Mar 2024·Journal of thoracic oncology : official publication of the International Association for the Study of Lung Cancer

A Phase 1b Study of Ivonescimab, a Programmed Cell Death Protein-1 and Vascular Endothelial Growth Factor Bispecific Antibody, as First- or Second-Line Therapy for Advanced or Metastatic Immunotherapy-Naive NSCLC

Article

Author: Li, Baiyong ; Luo, Yongzhong ; Zhou, Jin ; Song, Weifeng ; Xia, Yu ; Zhang, Xiaodong ; Hou, Xiaoming ; Zhang, Zhihong ; Ren, Shengxiang ; Su, Chunxia ; Wang, Zhongmin Maxwell ; Dai, Yuanrong ; Zhou, Caicun ; Meng, Shuyan ; Wu, Fengying ; Wang, Lei ; Hu, Yanping ; Dong, Xiaorong ; Xiong, Anwen ; Yu, Xinmin

INTRODUCTION:

This study (HARMONi-5) aimed to evaluate the safety and efficacy of ivonescimab (a bispecific antibody against programmed cell death protein 1 and vascular endothelial growth factor) as first- or second-line monotherapy in patients with advanced immunotherapy-naive NSCLC.

METHODS:

Eligible patients received intravenous ivonescimab 10 mg/kg every 3 weeks (Q3W), 20 mg/kg every 2 weeks (Q2W), 20 mg/kg Q3W, or 30 mg/kg Q3W. The primary end points were safety and objective response rate (ORR) per Response Evaluation Criteria in Solid Tumors version 1.1.

RESULTS:

At data cutoff (October 5, 2022), 108 patients were enrolled and received ivonescimab. Programmed death ligand-1 tumor proportion score (TPS) was greater than or equal to 1% in 74 patients (68.5%), including 35 (32.4%) with TPS greater than or equal to 50%. The median follow-up was 10.4 months (range: 8.4-10.9 mo). For all patients, ORR and disease control rate were 39.8% and 86.1%, respectively. ORR by TPS was 14.7%, 51.4%, and 57.1% in patients with TPS less than 1%, greater than or equal to 1%, and greater than or equal to 50%, respectively. In the 67 programmed death ligand-1-positive patients receiving first-line ivonescimab, the ORR was 33.3%, 52.6%, 60.0%, and 75.0% at the doses of 10 mg/kg Q3W, 20 mg/kg Q2W, 20 mg/kg Q3W, and 30 mg/kg Q3W, respectively. Grade greater than or equal to 3 treatment-related adverse events (TRAEs) were observed in 24 patients (22.2%). TRAEs leading to treatment discontinuation occurred in one patient (0.9%). TRAEs leading to death occurred in three patients (2.8%) with squamous NSCLC. The occurrence of grade greater than or equal to 3 TRAEs and grade greater than or equal to 3 bleeding events in squamous versus nonsquamous NSCLC patients was 25.5% versus 18.9% and 0.0% versus 1.9%, respectively.

CONCLUSIONS:

Ivonescimab monotherapy was well tolerated and found to have a promising efficacy in patients with advanced or metastatic NSCLC.

CLINICALTRIALS:

gov identifier: NCT04900363.

01 Aug 2023·EClinicalMedicine

AK112, a novel PD-1/VEGF bispecific antibody, in combination with chemotherapy in patients with advanced non-small cell lung cancer (NSCLC): an open-label, multicenter, phase II trial

Article

Author: Xia, Michelle ; Li, Baiyong ; Zhao, Yuanyuan ; Song, Weifeng ; Yang, Yunpeng ; Zhao, Yanqiu ; Chen, Gang ; Zhang, Weidong ; Zhang, Yu ; Li, Wenting ; Zhuang, Wu ; Zhuang, Li ; Du, Yingying ; Zhou, Ming ; Huang, Yan ; Wan, Yixin ; Chen, Jianhua ; Zhang, Li ; Fang, Wenfeng ; Wang, Zhongmin Maxwell ; Yu, Qitao

Background:

Inhibiting vascular endothelial growth factor (VEGF) function can improve the efficacy of immunotherapy by modulating the tumor immune microenvironment. AK112 is the first-in-class humanized IgG1 bispecific antibody targeting programmed death-1 (PD-1) and VEGF. This study aimed to evaluate the efficacy and safety of AK112 combined with chemotherapy in patients with advanced non-small cell lung cancer (NSCLC).

Methods:

This open-label, multicenter, phase II clinical trial was conducted in 11 hospitals in China. Eligible participants were adults aged 18-75 years with locally advanced or metastatic NSCLC, an Eastern Cooperative Oncology Group performance status of 0 or 1, at least one measurable lesion, and an estimated life expectancy of at least 3 months. The participants were categorized into three cohorts based on prior therapy and functional genomic alterations. Patients in cohort 1 were previously untreated advanced NSCLC, had no epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) gene modifications, and received AK112 combined with pemetrexed (500 mg/m²) for non-squamous (non-sq)-NSCLC or paclitaxel (175 mg/m²) for sq-NSCLC plus carboplatin (area under the curve of 5 mg/mL per min) for four cycles, followed by AK112 with pemetrexed for non-sq-NSCLC and AK112 alone for sq-NSCLC as maintenance therapy. The participants in cohort 2 had advanced NSCLC with EGFR-sensitive mutations, failed previous EGFR-tyrosine kinase inhibitor (TKI) therapy, and received pemetrexed plus AK112 and carboplatin for four cycles, followed by pemetrexed plus AK112 as maintenance therapy. The participants in cohort 3 had advanced NSCLC who failed systemic platinum-based chemotherapy and anti-PD-1/programmed death-ligand 1 (PD-L1) treatments and received AK112 plus docetaxel (75 mg/m²). Two dosages of AK112 (10 or 20 mg/kg) were examined in each cohort, and the drug was administered intravenously on day 1 of each 3-week treatment cycle. The primary endpoints were the investigator-assessed objective response rate (ORR) and safety. This study was registered with ClinicalTrials.gov (NCT04736823).

Findings:

Eighty-three patients were enrolled from February 2021 to August 2022 and received the study treatment. Cohorts 1, 2, and 3 had 44, 19, and 20 patients, respectively. The confirmed ORR was 53.5% (23/43) [95% CI, 36.9-67.1], 68.4% (13/19) [95% CI, 43.4-87.4], and 40.0% (8/20) [95% CI, 19.1-63.9] in cohorts 1, 2, and 3, respectively. In cohort 1, the median PFS was not reached, and the 12-month PFS rate was 59.1%. In cohorts 2 and 3, the median PFS were 8.5 [95% CI, 5.5-NE] and 7.5 [95% CI, 2.3-NE] months, and the 12-month PFS rates were 35.5% and 44.5%, respectively. The most common grade ≥3 treatment-related adverse events were decreased white blood cell count [7 (8.4%)], neutropenia [5 (6.0%)], thrombocytopenia [2 (2.4%)], anemia [4 (4.8%)], and myelosuppression [2 (2.4%)].

Interpretation:

AK112 plus platinum-doublet showed promising antitumor activity and safety not only in first-line treatment of advanced NSCLC patients without driver mutation but also in patients with EGFR-functional mutation who failed previous EGFR-TKI therapy and advanced NSCLC patients who failed prior systemic platinum-based chemotherapy and PD-1/PD-L1 inhibitor treatments, suggesting a valuable potential new treatment option for this patient population.

Funding:

Akeso Biopharma, Inc., Zhongshan, China, and National Natural Science Foundation of China.

News (Medical) associated with Ivonescimab

27 Jun 2024

·www.biospace.com

Summit Therapeutics Appoints Jeff Huber, Transformational Google and GRAIL Executive, to its Board of Directors

MIAMI--(BUSINESS WIRE)-- Summit Therapeutics Inc. (NASDAQ: SMMT) (“Summit,” “we,” or the “Company”) today announced that Jeff Huber has been appointed to its Board of Directors, effective immediately. “It is an honor to add Jeff Huber to our excellent, diverse group of board members,” stated Robert W. Duggan, Chairman and Chief Executive Officer of Summit. “Jeff’s executive leadership experience in healthcare and technology and his countless accomplishments evidence his ability to translate what’s possible into transformational success. As we seek to change the standard of care for solid tumors based on the potential of ivonescimab, we are thrilled to supplement our outstanding leadership team with a board member the caliber of Jeff.” Mr. Huber is the Co-Founder & General Partner of Triatomic Capital Private LP since 2022, a venture capital firm helping entrepreneurs build 'century-defining' businesses & technologies. Prior to founding Triatomic, Mr. Huber was the Founding CEO and Vice Chairman of GRAIL, Inc. GRAIL's mission is to detect cancer early, when it can be cured. Prior to GRAIL, he was a Senior Vice President at Alphabet Inc. (formerly Google Inc.). Over 13 years at Google, Mr. Huber co-founded Google's life sciences efforts in Google[x], and he led development and scaling for Google Maps, Google Apps (Gmail, Calendar, Docs, etc.), and Google Ads. Earlier, Mr. Huber was VP of Architecture and Systems Development at eBay and SVP of Engineering at Excite@Home. He is a board member of both publicly traded and privately held companies, including Mammoth Biosciences, Inc., Manifold Biotechnologies, Inc., Electronic Arts Inc., Upstart Network, Inc., Openwater, Genalyte, Inc., Zapata Computing Inc., Weta FX Ltd, d-Matrix Corp., and the Parker Institute for Cancer Immunotherapy, and is a former board member of GRAIL, Inc., Aldevron LLC, and Illumina, Inc. Mr. Huber holds a B.S. in Computer Engineering from the University of Illinois and an M.B.A. from Harvard Business School. “Jeff’s breadth and depth of experience is unmatched,” added Dr. Maky Zanganeh, Chief Executive Officer, President, and a member of the Board of Directors of Summit. “I am thrilled to be working with Jeff as a member of our board to further propel Team Summit to achieving our goal of bringing ivonescimab to as many patients as possible who can benefit from our innovative bispecific antibody candidate.” “I am excited to join a mission-driven company seeking to make a significant, positive difference in improving the quality and potential duration of patients’ lives,” said Mr. Huber. “An opportunity to join the Board of Directors and to work with Team Summit is a tremendous opportunity to make that difference, and I am confident in Team Summit’s ability to achieve its mission.” About Ivonescimab Ivonescimab, known as SMT112 in Summit’s license territories, the United States, Canada, Europe, Japan, Latin America, including Mexico and all countries in Central America, South America, and the Caribbean, the Middle East, and Africa, and as AK112 in China and Australia, is a novel, potential first-in-class investigational bispecific antibody combining the effects of immunotherapy via a blockade of PD-1 with the anti-angiogenesis effects associated with blocking VEGF into a single molecule. Ivonescimab displays unique cooperative binding to each of its intended targets with higher affinity when in the presence of both PD-1 and VEGF. This could differentiate ivonescimab as there is potentially higher expression (presence) of both PD-1 and VEGF in tumor tissue and the tumor microenvironment (TME) as compared to normal tissue in the body. Ivonescimab’s tetravalent structure (four binding sites) enables higher avidity (accumulated strength of multiple binding interactions) in the TME with over 18-fold increased binding affinity to PD-1 in the presence of VEGF in vitro, and over 4-times increased binding affinity to VEGF in the presence of PD-1 in vitro (Zhong, et al, SITC, 2023). This tetravalent structure, the intentional novel design of the molecule, and bringing these two targets into a single bispecific antibody with cooperative binding qualities have the potential to direct ivonescimab to the tumor tissue versus healthy tissue. The intent of this design, together with a half-life of 6 to 7 days (Zhong, et al, SITC, 2023), is to improve upon previously established efficacy thresholds, in addition to side effects and safety profiles associated with these targets. Ivonescimab was engineered by Akeso Inc. (HKEX Code: 9926.HK) and is currently engaged in multiple Phase III clinical trials. Over 1,600 patients have been treated with ivonescimab in clinical studies globally. Summit has begun its clinical development of ivonescimab in non-small cell lung cancer (NSCLC), commencing enrollment in 2023 in two Phase III clinical trials, HARMONi and HARMONi-3. HARMONi is a Phase III clinical trial which intends to evaluate ivonescimab combined with chemotherapy compared to placebo plus chemotherapy in patients with EGFR-mutated, locally advanced or metastatic non-squamous NSCLC who have progressed after treatment with a 3rd generation EGFR TKI (e.g., osimertinib). HARMONi-3 is a Phase III clinical trial which is designed to evaluate ivonescimab combined with chemotherapy compared to pembrolizumab combined with chemotherapy in patients with first-line metastatic squamous NSCLC. Ivonescimab is an investigational therapy that is not approved by any regulatory authority in Summit’s license territories, including the United States and Europe. Ivonescimab was approved for marketing authorization in China in May 2024. About Summit Therapeutics Summit Therapeutics Inc. is a biopharmaceutical oncology company focused on the discovery, development, and commercialization of patient-, physician-, caregiver- and societal-friendly medicinal therapies intended to improve quality of life, increase potential duration of life, and resolve serious unmet medical needs. Summit was founded in 2003 and our shares are listed on the Nasdaq Global Market (symbol "SMMT"). We are headquartered in Miami, Florida, and we have additional offices in Menlo Park, California, and Oxford, UK. For more information, please visit and follow us on X @SMMT_TX. Summit Forward-looking Statements Any statements in this press release about the Company’s future expectations, plans and prospects, including but not limited to, statements about the clinical and preclinical development of the Company’s product candidates, entry into and actions related to the Company’s partnership with Akeso Inc., including the expected benefits of the amendment to the collaboration and license agreement, the intended use of the net proceeds from the private placement, the Company's anticipated spending and cash runway, the therapeutic potential of the Company’s product candidates, the potential commercialization of the Company’s product candidates, the timing of initiation, completion and availability of data from clinical trials, the potential submission of applications for marketing approvals, potential acquisitions, statements about the previously disclosed At-The-Market equity offering program (“ATM Program”), the expected use proceeds and uses thereof, and other statements containing the words "anticipate," "believe," "continue," "could," "estimate," "expect," "intend," "may," "plan," "potential," "predict," "project," "should," "target," "would," and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including the Company’s ability to sell shares of our common stock under the ATM Program, the conditions affecting the capital markets, general economic, industry, or political conditions, including the results of our evaluation of the underlying data in connection with the development and commercialization activities for ivonescimab, the outcome of discussions with regulatory authorities, including the Food and Drug Administration, the uncertainties inherent in the initiation of future clinical trials, availability and timing of data from ongoing and future clinical trials, the results of such trials, and their success, and global public health crises, that may affect timing and status of our clinical trials and operations, whether preliminary results from a clinical trial will be predictive of the final results of that trial or whether results of early clinical trials or preclinical studies will be indicative of the results of later clinical trials, whether business development opportunities to expand the Company’s pipeline of drug candidates, including without limitation, through potential acquisitions of, and/or collaborations with, other entities occur, expectations for regulatory approvals, laws and regulations affecting government contracts and funding awards, availability of funding sufficient for the Company’s foreseeable and unforeseeable operating expenses and capital expenditure requirements and other factors discussed in the "Risk Factors" section of filings that the Company makes with the Securities and Exchange Commission. Any change to our ongoing trials could cause delays, affect our future expenses, and add uncertainty to our commercialization efforts, as well as to affect the likelihood of the successful completion of clinical development of ivonescimab. Accordingly, readers should not place undue reliance on forward-looking statements or information. In addition, any forward-looking statements included in this press release represent the Company’s views only as of the date of this release and should not be relied upon as representing the Company’s views as of any subsequent date. The Company specifically disclaims any obligation to update any forward-looking statements included in this press release.

Executive ChangePhase 3Drug Approval

10 Jun 2024

·www.drugs.com

American Society of Clinical Oncology, May 30-June 4

The annual meeting of the American Society of Clinical Oncology was held from May 30 to June 4 in Chicago and hosted more than 34,000 participants from around the world, including clinicians, academicians, allied health professionals, and others interested in oncology. The conference featured the latest advances in clinical cancer research, including oral abstract presentations and poster presentations in disease-based and specialty tracks. Presentations focused on novel targeted therapies as well as improvements in chemotherapy and radiation therapy approaches. In one study, Jefferson DeKloe, M.D., of Thomas Jefferson University in Philadelphia, and colleagues found that human papillomavirus (HPV) vaccination reduces the risk for cervical cancer and precancerous dysplasia in female patients and may reduce the incidence of other HPV-associated cancers, including head and neck cancers in men. The authors performed a retrospective cohort study using the data from the TriNetX U.S. Collaborative Network. Patients aged 9 to 39 years who received any vaccine between Jan. 1, 2010, and Dec. 31, 2023, were included in the analysis. Patients were divided into two cohorts: those vaccinated for HPV at least five years prior and those with no history of HPV vaccination. The development of malignancies across various organ systems, including head and neck, cervix, anus and anal canal, penis, vulva, and vagina, was assessed. The researchers observed lower rates of cervical cancer in female participants vaccinated for HPV compared with those not vaccinated. Furthermore, lower rates of head and neck cancer were observed in male patients vaccinated for HPV compared with those not vaccinated. "There are still many variables that influence the risk of developing an HPV-associated cancer and future research may inform us what is causing the reduced incidence of head and neck cancers in HPV-vaccinated males," DeKloe said. "This work shows that the HPV-vaccination efforts in the United States may already have some apparent benefit measured through the reduction of HPV-associated cancers. Given the rise in HPV-related cancers in the past few decades, HPV vaccination is an important means of cancer prevention that should be emphasized for male and female patients in clinical practice." One author disclosed a financial relationship with AstraZeneca. Abstract No. 10507 In a large-scale comparative effectiveness trial across 22 cancer centers, Joseph Greer, M.D., of Massachusetts General Hospital and Harvard Medical School in Boston, and colleagues demonstrated equivalence for the effect of delivering early palliative care via video versus in-person visits on quality of life in patients with advanced lung cancer. The authors focused on the use of video visits to deliver palliative care, as according to the authors, they require fewer clinical resources and may be a more efficient way for clinicians to provide care. The researchers also note that video visits save patients time and money compared with going to the hospital or clinic to meet with the clinician. The trial included 1,250 patients, with 633 in the video-visit palliative care group and 617 in the in-person palliative care group. In addition, 548 caregivers (i.e., a family member or friend who was involved in the patient's care) were enrolled in the study. All patients who participated in the study received early palliative care that began soon after their diagnosis and continued throughout the course of their disease. Patients in both study groups had contact with the palliative care clinician every four weeks, with the visits occurring predominantly in clinic for those randomly assigned to in-person palliative care and via video visits for those assigned to telehealth palliative care. The researchers found that medical care, such as palliative care, can be delivered through video visits and patients and their family caregivers receive the same quality-of-life benefits as with in-person palliative care. The two study groups also did not differ in their reported satisfaction with care or with respect to patient- and caregiver-reported mood symptoms. "The equivalence of these modalities in a population with serious illness underscores the urgent need for clinicians, health care systems, and policymakers to expand equitable access to evidence-based palliative care and develop guidelines for a new standard of care that includes the broad adoption of telehealth services," Greer said. Several authors disclosed ties to the biopharmaceutical industry. Abstract No. LBA3 In a prospective study, Kimia Sorouri, M.D., of the Dana-Farber Cancer Institute in Boston, and colleagues followed breast cancer survivors over 10 years to determine fertility outcomes in those attempting pregnancy, with the majority achieving pregnancy and most experiencing live births. The authors evaluated women with stage 0 to III breast cancer included in the Young Women's Breast Cancer Study who reported attempting pregnancy postdiagnosis (1,213 eligible female participants, including 197 reporting any attempt of pregnancy). The researchers found that 73 percent reported at least one pregnancy after diagnosis and 65 percent experienced at least one live birth after diagnosis. "This is the first prospective study with greater than 10 years of follow-up to report fertility outcomes in young breast cancer survivors accounting for attempting pregnancy," the authors write. "Our findings can be incorporated into the counseling of young breast cancer patients and survivors, and highlight the need for accessibility of fertility preservation services for this population." Several authors disclosed ties to the pharmaceutical, medical device, and medical technology industries. Abstract No. 1518 ASCO: Germline Variation Does Not Predict Taxane-Induced Peripheral Neuropathy FRIDAY, June 7, 2024 -- Germline variation does not predict the risk of taxane-induced peripheral neuropathy in Black women receiving paclitaxel (once weekly) or docetaxel (every three weeks) for early-stage breast cancer, according to a study published online June 3 in the Journal of Clinical Oncology to coincide with the annual meeting of the American Society of Clinical Oncology, held from May 31 to June 4 in Chicago. Read Full Text ASCO: Ivonescimab Improves Progression-Free Survival in EGFR + Lung Cancer THURSDAY, June 6, 2024 -- For patients with non-small cell lung cancer with the epidermal growth factor receptor variant, ivonescimab plus chemotherapy improves progression-free survival, according to a study published online May 31 in the Journal of the American Medical Association to coincide with the annual meeting of the American Society of Clinical Oncology, held from May 31 to June 4 in Chicago. Read Full Text ASCO: Osimertinib Improves Progression-Free Survival in EGFR -Mutated Lung Cancer WEDNESDAY, June 5, 2024 -- For patients with unresectable stage III EGFR -mutated non-small cell lung cancer, treatment with osimertinib results in significantly longer progression-free survival, according to a study published online June 2 in the New England Journal of Medicine to coincide with the annual meeting of the American Society of Clinical Oncology, held from May 31 to June 4 in Chicago. Read Full Text ASCO: Neoadjuvant Ipilimumab + Nivolumab Ups Survival in Resectable Melanoma WEDNESDAY, June 5, 2024 -- Neoadjuvant ipilimumab plus nivolumab followed by surgery results in longer event-free survival than surgery followed by adjuvant nivolumab among patients with resectable, macroscopic stage III melanoma, according to a study published online June 2 in the New England Journal of Medicine to coincide with the annual meeting of the American Society of Clinical Oncology, held from May 31 to June 4 in Chicago. Read Full Text ASCO: Asciminib Has Superior Efficacy to TKIs for Newly Diagnosed Leukemia WEDNESDAY, June 5, 2024 -- For patients with newly diagnosed chronic myeloid leukemia, asciminib shows superior efficacy and a favorable safety profile compared with investigator-selected tyrosine kinase inhibitors, according to a study published online May 31 in the New England Journal of Medicine to coincide with the annual meeting of the American Society of Clinical Oncology, held from May 31 to June 4 in Chicago. Read Full Text ASCO: Stepped-Care Model Noninferior to Early Palliative Care for Advanced Cancer TUESDAY, June 4, 2024 -- For patients with advanced lung cancer, a stepped-care model with palliative care visits occurring at key points in patients' cancer trajectory is noninferior to early palliative care, according to a study published online June 2 in the Journal of the American Medical Association to coincide with the annual meeting of the American Society of Clinical Oncology, held from May 31 to June 4 in Chicago. Read Full Text ASCO: Conjugated Equine Estrogen May Increase Risk for Ovarian Cancer TUESDAY, May 28, 2024 -- Conjugated equine estrogen taken alone for menopause may increase the risk for developing and dying from ovarian cancer, according to a study presented at the annual meeting of the American Society of Clinical Oncology, held from May 31 to June 4 in Chicago. Read Full Text ASCO: Survivors of Early Breast Cancer Can Successfully Attempt Pregnancy THURSDAY, May 23, 2024 -- Most survivors of stage 0 to III breast cancer who attempt pregnancy postdiagnosis are able to become pregnant and have a live birth, according to a study presented at the annual meeting of the American Society of Clinical Oncology, held from May 31 to June 4 in Chicago. Read Full Text ASCO: HPV Vaccination Positively Affecting More Than Just Cervical Cancer Risk THURSDAY, May 23, 2024 -- Human papillomavirus vaccination is associated with reduced odds of several types of HPV-related cancers, not just cervical cancer, according to a study presented at the annual meeting of the American Society of Clinical Oncology, held from May 31 to June 4 in Chicago. Read Full Text Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.

ASCOClinical Result

07 Jun 2024

·www.fiercepharma.com

Fierce Pharma Asia—Enhertu's encore; Akeso's showstopper; GenScript and Legend's US scrutiny

Several Asian biopharma companies made waves at the American Society of Clinical Oncology annual meeting in Chicago. AstraZeneca and Daiichi Sankyo are looking at moving their antibody-drug conjugate Enhertu into another new breast cancer patient class. Ahead of the American Society of Clinical Oncology annual meeting, a cancer antibody from Akeso and Summit Therapeutics stole the show. More Chinese biopharma players are coming under scrutiny from U.S. lawmakers. Plus more. 1. ASCO: AstraZeneca, Daiichi's Enhertu looks to make history again in HER2-ultralow breast cancer After AstraZeneca and Daiichi Sankyo's Enhertu pioneered the HER2-low category in breast cancer treatment, the partners ignited discussion around the "HER2-ultralow" treatment category at this year's American Society of Clinical Oncology meeting. In a subgroup analysis of the DESTINY-Breast06 trial, Enhertu cut the risk of disease progression or death by 22% versus chemo in certain "HER2-ultralow" patients. The number didn't bear statistical significance. Company executives expressed excitement about the results while experts raised questions about identifying the right patients. 2. Akeso, Summit's Keytruda win draws 'explosive' interest at ASCO. But what does Merck think? On the eve of the American Society of Clinical Oncology's (ASCO's) annual meeting, Akeso and Summit Therapeutics' ivonescimab essentially stole the show with data demonstrating the partners' medicine beat Merck & Co.'s Keytruda in a head-to-head phase 3 trial in lung cancer on the endpoint of progression-free survival. In an interview with Fierce Pharma, Merck's chief medical officer Eliav Barr, M.D., said that overall survival results will remain key as the story plays out. Still, the results elicited a strong response at the ASCO conference. 3. Lawmakers request intelligence briefing on CDMO GenScript, Legend Biotech's ties to China As a U.S. biosecurity crackdown rolls on, two House lawmakers requested FBI director Christopher Wray and U.S. director of national intelligence Avril Haines provide a briefing on the CDMO GenScript and several of its subsidiaries, including the cell therapy specialist Legend Biotech. The lawmakers didn't allege any illicit behavior, but they said the companies' actions "underscore the need for vigilance in safeguarding U.S. competitiveness." 4. ASCO: AstraZeneca, AbelZeta’s solid tumor CAR-T shows promise in early trial (Release) Sino-American biotech AbelZeta, along with multinational AstraZeneca, had their own update to share at the American Society of Clinical Oncology event. In a small study in patients with heavily pretreated advanced hepatocellular carcinoma, the companies' solid tumor CAR-T drug C-CAR031 delivered promising early results. Among 23 study participants who could be evaluated, 91% experienced reductions in the size of their tumors. The data "provide compelling proof-of-concept to potentially redefine therapeutic paradigms" in hepatocellular carcinoma and certain other cancers, AbelZeta CEO Tony (Bizuo) Liu said in a statement. 5. FDA cracks down on China's Hengrui in scathing manufacturing write-up After an inspection early this year, the FDA handed China's Jiangsu Hengrui Pharmaceuticals a Form 483 manufacturing reprimand with eight observations. Among the agency's findings, the FDA said the company failed to make production records readily available and that it failed to establish adequate sterilization processes. While the company recently received an FDA rejection on an approval application, the manufacturing findings were not related to that decision, a Hengrui spokesperson said. Even though the inspection happened in January, the FDA just posted the Form 483 document this week. 6. South Korea, Japan, India and others form pharma alliance (Yonhap News Agency) Several large countries, including South Korea, Japan, India and the U.S., formed an alliance to bolster the global pharmaceutical supply chain, Yonhap News Agency reports. Dubbed the Biopharmaceutical Alliance, the group met this week at the BIO convention in San Diego. The participants, which include government officials and biopharma industry representatives, pledged to work together on policies and regulations to advance their effort, the news service reports. Other News of Note: 7. Otsuka mauled by ad body for 'unacceptable' transparency failing 8. Lotte Biologics, Merck KGaA ink partnership deal for biopharma production 9. Otsuka, Lundbeck run CGI Abilify ad in promotional push for long-acting bipolar drug 10. Sun Pharma brightens up Ilumya promos with psoriasis campaign encouraging self-love

Clinical ResultASCOPhase 3Cell Therapy

100 Deals associated with Ivonescimab

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
EGFR positive Non-squamous non-small cell lung cancer	CN	Akeso-Sino Pharma Co., Ltd.	21 May 2024

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Squamous non-small cell lung cancer	Phase 3	CN	Akeso Biopharma Co., Ltd.	17 Aug 2023
PD-L1 positive Non-Small Cell Lung Cancer	Phase 3	CN	Akeso Biopharma Co., Ltd.	21 Oct 2022
Hepatocellular Carcinoma	Phase 3	-	Akeso Biopharma Co., Ltd.	-
Microsatellite Stable Colorectal Carcinoma	Phase 2	CN	Akeso Biopharma Co., Ltd.	10 May 2023
Unresectable Hepatocellular Carcinoma	Phase 2	-	Akeso Biopharma Co., Ltd.	01 Aug 2022
Metastatic Colorectal Carcinoma	Phase 2	CN	Akeso Biopharma Co., Ltd.	25 Jul 2022
Advanced Triple-Negative Breast Carcinoma	Phase 2	CN	Akeso Biopharma Co., Ltd.	23 Mar 2022
Metastatic Triple-Negative Breast Carcinoma	Phase 2	CN	Akeso Biopharma Co., Ltd.	23 Mar 2022
Platinum-Resistant Ovarian Carcinoma	Phase 2	CN	Akeso Biopharma Co., Ltd.	30 Jan 2022
Advanced cancer	Phase 2	CN	Akeso Biopharma Co., Ltd.	25 Jan 2022

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05499390 (AK112-303 \| HARMONi-2, NEWS) Manual	Phase 3	PD-L1 positive Non-Small Cell Lung Cancer First line PD-L1 Positive	398	依沃西	vaewgaoqmb(bxqlokyfjk) = 在意向治疗人群(ITT)中，依沃西组相较于帕博利珠组显著延长了患者无进展生存期（PFS），风险比（HR）显著优于预期 eggdhhsrnz (hhfysghrul ) Met	Superior	31 May 2024
NCT05499390 (AK112-303 \| HARMONi-2, NEWS) Manual	Phase 3		398	帕博利珠		Superior	31 May 2024
NCT05184712 (HARMONi-A, ASCO2024) Manual	Phase 3	EGFR positive Non-squamous non-small cell lung cancer EGFR T790M	322	Ivonescimab + Chemotherapy	fomjstwibv(cnevkctatg) = lmeyuwkvhy cgiakxbxeh (nupjzcptda, 5.85 - 8.74) View more	Positive	24 May 2024
NCT05184712 (HARMONi-A, ASCO2024) Manual	Phase 3		322	Placebo + Chemotherapy	fomjstwibv(cnevkctatg) = fpoklzxaea cgiakxbxeh (nupjzcptda, 4.21 - 5.55) View more	Positive	24 May 2024
NCT04047290 (Phase 1a dose escalation study of ivonescimab, Pubmed)	Phase 1	Advanced Malignant Solid Neoplasm PD-1 \| VEGF-A	51	Ivonescimab 20 mg/kg	cynqqknniw(gyjoftsevy) = teitnjlabq vhfmascppw (hbaoifitxf ) View more	Positive	19 Apr 2024
	Phase 1	Advanced Malignant Solid Neoplasm PD-1 \| VEGF-A	51	Ivonescimab 30 mg/kg	hdfqhjgixx(jmlevekxrm) = lrgwuydkhz damxnkvpla (fespmwubbl )	Positive	19 Apr 2024
NCT04736823 \| NCT04900363 (AK112-202, ESMO_ELCC2024) Manual	Phase 1/2	Brain metastases \| Non-Small Cell Lung Cancer First line	35	ivonescimab+platinum doublet chemotherapy (AK112-201)	zvtvowhrrd(binwyokbks) = 12 pts (34%) achieved an IC response. Of these, 11 had received PC/ivo, among whom 7 achieved an IC complete response (CR); 1 pt achieved an IC CR among the 7 pts who received ivo alone. nlhvsikeue (aappwwkldq ) View more	Positive	22 Mar 2024
NCT04736823 \| NCT04900363 (AK112-202, ESMO_ELCC2024) Manual	Phase 1/2	Brain metastases \| Non-Small Cell Lung Cancer First line	35	ivonescimab+platinum doublet chemotherapy (AK112-202)		Positive	22 Mar 2024
NCT04736823 (ESMO_ELCC2024) Manual	Phase 2	Squamous non-small cell lung cancer First line	63	Ivonescimab	bzazyxkrde(ggfbbqazor) = fpyexygfca jrkqwapeah (gnuwlpltan ) View more	Positive	20 Mar 2024
NCT04900363 (HARMONi-5, Pubmed)	Phase 1	Non-Small Cell Lung Cancer Second line programmed death ligand-1 tumor proportion score (TPS)	108	Ivonescimab 10 mg/kg Q3W	llnzwiwopz(vcvxdmudfm) = rhqdcdxlic bymbjckczv (vjbostijdj )	Positive	01 Mar 2024
NCT04736823 (AK112-201, BusinessWire) Manual	Phase 2	Squamous non-small cell lung cancer First line	63	AK112+chemotherapy	zabeycbboh(ngexjggvrg) = pniavtomeg zhtxxsnmtb (eyczcgziwn ) View more	Positive	08 Jan 2024
NCT04736823 (AK112-201, BusinessWire) Manual	Phase 2	EGFR-mutated non-small Cell Lung Cancer Second line EGFR Mutation	19	Ivonescimab+chemotherapy	czxaanqyti(otbpiinvrk) = gbywmwztbv btjslnzpms (isfxjdfiqz ) View more	Positive	08 Jan 2024
NCT05184712 (HARMONi, ESMO2023)	Phase 3	EGFR positive Non-squamous non-small cell lung cancer	470	Ivonescimab	hppkzloaah(fudvintojc) = xusvdxnqfa vjhqhejzyo (lfoogyzwie )	-	23 Oct 2023
NCT04736823 (AK112-201, Biospace) Manual	Phase 2	Squamous non-small cell lung cancer First line	-	Ivonescimab+chemotherapy	kimokmyfph(fazhhcjbge) = gunzaodiov ahhsxepmko (psrijdshgl, 53 - 78) View more	Positive	09 Aug 2023

Translational Medicine

Boost your research with our translational medicine data.

view full example data

Deal

Boost your decision using our deal data.

view full example data

Core Patent

Boost your research with our Core Patent data.

view full example data

Clinical Trial

Identify the latest clinical trials across global registries.

view full example data

Approval

Accelerate your research with the latest regulatory approval information.

view full example data

Regulation

Understand key drug designations in just a few clicks with Synapse.

view full example data

Get started for free today!

Accelerate Strategic R&D decision making with Synapse, PatSnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.

Start your data trial now!

Synapse data is also accessible to external entities via APIs or data packages. Leverages most recent intelligence information, enabling fullest potential.

Bio

Bio Sequences Search & Analysis

Chemical

Chemical Structures Search & Analysis

Ivonescimab

Overview

Basic Info

Gene Sequence

Related

R&D Status

Clinical Result

Translational Medicine

Deal

Core Patent

Clinical Trial

Approval

Regulation