Lynparza + abiraterone approved in Japan for the treatment of BRCA-mutated mCRPC
Mototsugu Oya, Professor and Chairman, Department of Urology, Keio University School of Medicine, Japan, said: “The PROpel trial showed that the combination of Lynparza plus abiraterone delivered clinically meaningful improvements in outcomes for patients with BRCA-mutated metastatic castration-resistant prostate cancer. With this approval, patients in Japan will now have the opportunity to benefit from this […]
Day One Announces VRK1 License Agreement and Research Collaboration with Sprint Bioscience
“This collaboration is an important continuation of measured portfolio development at Day One, which focuses on targeted therapies for children and adults with cancer in need of novel treatment approaches,” said Dr. Samuel Blackman, co-founder and head of research and development, Day One. “We look forward to collaborating with Sprint Bioscience, who has strong discovery […]
Two programmes evaluating CD47-blocking fusion protein evorpacept for patients with haematologic malignancies discontinued
“Based on the initial results of ASPEN-02 and the close connection between the mechanism of action with azacitidine in MDS and acute myeloid leukemia (“AML”), the Company will also terminate the ASPEN-05 program in AML and will not initiate a Phase 1b dose optimization clinical evaluation of evorpacept in combination with azacitidine and venetoclax. Based […]
Partial Clinical Hold Lifted on iMMagine-1 Phase 2 Clinical Program
“We have worked closely with FDA to expeditiously resolve the clinical hold and we thank them for their collaboration and dialogue throughout this process,” said Rami Elghandour, Arcellx’s Chairman and Chief Executive Officer. “During the review process, we updated our trial protocol, and were pleased that FDA allowed for expanded bridging therapies, which better aligns our protocol […]
Phase 3 Trial of TUKYSA + ado-trastuzumab emtansine Meets Primary Endpoint of PFS in Patients with Previously Treated HER2-Positive Metastatic Breast Cancer
“We are encouraged by these results for TUKYSA in combination with Kadcyla®in metastatic HER2-positive breast cancer, including in patients with brain metastases,” said Roger Dansey, President of Research and Development and Chief Medical Officer at Seagen. “We plan to present the HER2CLIMB-02 data at an upcoming medical meeting and discuss the results with the FDA.”
WELIREG® (belzutifan) Phase 3 LITESPARK-005 Trial Met Primary Endpoint of PFS in Certain Previously Treated Patients With Advanced RCC
“Patients with advanced RCC face low survival rates, and for those whose cancer progresses following PD-1/L1 and VEGF-TKI therapies, there is a need for new treatment options that can reduce their risk of disease progression or death,” said Dr. Marjorie Green, senior vice president and head of late-stage oncology, global clinical development, Merck Research Laboratories. […]
First Data from Ongoing Multicenter Phase 1/2 Clinical Trial Evaluating MB-106 CAR-T Cell Therapy Announced
Manuel Litchman, M.D., President and Chief Executive Officer of Mustang, said, “We are encouraged that the first data from the multicenter trial of our lead candidate, MB-106, show clinical responses and that the trial is on track to achieve results consistent with those from the ongoing trial taking place at Fred Hutch. Overall, MB-106 continues […]
Data Highlighting Clinical Efficacy & Molecular Mechanisms of Response to ONC201 Treatment of H3 K27M-Mutant Diffuse Midline Gliomas Published in “Cancer Discovery”
“The survival analyses published today in Cancer Discovery reported that ONC201 frontline treatment, administered post radiation therapy, demonstrated a statistically significant increase in mOS from diagnosis versus historical controls (21.7 months mOS vs. 12 months mOS, p<0.0001). These data are particularly relevant given that enrollment in the ongoing ACTION study occurs in a similar population. […]
Odronextamab Receives EMA Filing Acceptance for Treatment of R/R FL and DLBCL
“Regeneron Pharmaceuticals announced that the European Medicines Agency (EMA) has accepted for review the Marketing Authorization Application (MAA) for odronextamab to treat adult patients with relapsed/refractory (R/R) follicular lymphoma (FL) or R/R diffuse large B-cell lymphoma (DLBCL), who have progressed after at least two prior systemic therapies. The EMA previously granted odronextamab Orphan Drug Designation […]
FDA Filing Acceptance and Priority Review for TIBSOVO in the Treatment of IDH1-mutated R/R Myelodysplastic Syndromes (MDS) announced
“Servier continues to drive our leadership in the scientific innovation behind targeted mutant IDH inhibition, transforming the treatment landscape for thousands of patients living with difficult and hard-to-treat cancers,” said Susan Pandya, M.D., Vice President Clinical Development and Head of Cancer Metabolism Global Development Oncology & Immuno-Oncology, Servier. “This filing acceptance and Priority Review for […]
Submission of Phase 3 Protocol to FDA to Initiate VERSATILE-003 Trial Announced
“Submission of the protocol and supportive CMC documents for this Phase 3 registrational trial is an important milestone for PDS Biotech and our VERSATILE-003 program investigating PDS0101 in combination with KEYTRUDA® as a potential treatment for recurrent or metastatic HPV16-positive HNSCC,” stated Dr. Lauren V. Wood, PDS Biotech’s Chief Medical Officer. “Interim data from our […]
Orphan Drug Designation Granted by the FDA to NXP800 for the Treatment of Cholangiocarcinoma
Ron Bentsur, Chairman and Chief Executive Officer of Nuvectis, commented, “We are pleased to have received this designation from the FDA for NXP800, which emphasizes the need for new, innovative therapies for the treatment of cholangiocarcinoma, a deadly malignancy with only limited treatment options available. NXP800 is an oral small molecule with a novel mechanism […]
LREXFIO™ Receives U.S. FDA Accelerated Approval for Relapsed or Refractory Multiple Myeloma
“ELREXFIO reflects our ongoing commitment to developing scientific breakthroughs that meaningfully improve outcomes for people with cancer. Discovered at Pfizer, we advanced this therapy from a first-in-patient trial to approval in less than five years, because we know that time is life for people living with multiple myeloma,” said Angela Hwang, Chief Commercial Officer and […]
European Commission Approves Reduced Dosing Frequency for TECVAYLI (teclistamab)
“Every patient’s experience with multiple myeloma is unique and requires a different treatment approach, tailored to their specific needs,” said Niels van de Donk, M.D., Professor of Hematology at Amsterdam University Medical Centers. “With a decreased incidence of new onset Grade 3 or higher infections, low discontinuation rates and depth of responses maintained, this biweekly […]
Astellas and Poseida Therapeutics Announce Strategic Investment to Support Poseida’s Commitment to Redefining Cancer Cell Therapy
“By leveraging our extensive expertise, experience in cancer biology and unique technologies, we are focused on reinvigorating the immune system’s ability to discover, disarm and destroy cancers in more patients. We are pursuing this ambitious goal through innovative and multifunctional modality platforms, using the capabilities at our global R&D sites as well as through partnership […]
Astex Expands Drug Discovery Collaboration With MSD
“Astex is applying its fragment-based drug discovery capability to design and generate small molecule modulators tailored to a wide range of potentially important therapeutic targets,” said Harren Jhoti, president and CEO of Astex. “This new alliance builds on our existing productive collaboration and allows us to combine our expertise and assets with MSD’s wide-ranging oncology […]
VANFLYTA® Now Available in U.S. for Patients with Newly Diagnosed FLT3-ITD Positive AML
“With VANFLYTA now available by prescription in the U.S., physicians and patients have a new treatment option for the aggressive FLT3-ITD subtype of acute myeloid leukemia,” said Dan Switzer, Head of U.S. Oncology Business, Daiichi Sankyo, Inc. “VANFLTYA is the first FLT3 inhibitor to be developed and approved specifically for FLT3-ITD positive AML and has […]
Enrollment opens for Keytruda® Arm in Ongoing Breast Cancer alpha-lactalbumin and AMHR2-ED-targeting Vaccine Clinical Trial
Dr. Amit Kumar, Chairman and CEO of Anixa stated, “Cleveland Clinic has demonstrated in both preclinical and clinical studies that our breast cancer vaccine induces an immune response–including, we believe, production of T cells that can target TNBC–so we believe that the addition of Keytruda could have a synergistic effect. If a vaccine induces the […]
FDA Approves TALVEY™ (talquetamab-tgvs) for the Treatment of Patients with Heavily Pretreated Multiple Myeloma
“The clinically meaningful efficacy and safety profile observed with talquetamab in heavily pretreated patients in this clinical trial, which included patients treated with prior BCMA-targeted bispecific or CAR-T cell therapy, has been notable,” said Ajai Chari, M.D., Director of Multiple Myeloma Program, Professor of Clinical Medicine at the University of California, San Francisco.* “Patients at […]
FDA Approves AKEEGA™ (Niraparib and Abiraterone Acetate) for the Treatment of Patients with BRCA-Positive mCRPC
“As a physician, identifying patients with a worse prognosis is a priority, especially those whose cancers have a BRCA mutation,” said Kim Chi, M.D., Medical Oncologist at BC Cancer – Vancouver and principal investigator of the Phase 3 MAGNITUDE study. “We prospectively designed the MAGNITUDE study to identify the subset of patients most likely to […]
Lily’s Donanemab poised for FDA’s approval
The positive outcome of Eli Lilly’s 18 months phase 3 randomized clinical trial on donanemab among 1736 participants with early Alzheimer disease (mild cognitive impairment/mild dementia) with amyloid and low/medium or high tau pathology was simultaneously presented and published at Alzheimer’s Association International Conference in Amsterdam and the journal JAMA respectively. Donanemab, an antibody designed […]
Replimune and Incyte Enter into Clinical Trial Collaboration and Supply Agreement to Evaluate RP1 and INCB99280 in Patients with Cutaneous Squamous Cell Carcinoma
“We are excited to enter into this collaboration with Incyte to explore the use of RP1 prior to surgery as we believe that our tumor-directed oncolytic immunotherapies could have a great impact in the neoadjuvant setting both in cutaneous squamous cell carcinoma (CSCC) and in other cancer types, given the high rates of complete responses […]
CG Oncology Announces $105 Million Oversubscribed Crossover Financing to Support Continued Advancement of Clinical-Stage Bladder Cancer Pipeline
“We are excited to welcome leading life science investors who share our vision of developing cutting-edge therapeutics addressing unmet medical needs in bladder cancer,” said Arthur Kuan, Chief Executive Officer, CG Oncology. “Our lead asset, cretostimogene grenadenorepvec, continues to make significant clinical progress in bladder cancer in both monotherapy and in combination studies and we […]
Horizon Technology Finance Provides $15 Million Venture Loan Facility to Tallac Therapeutics
“Tallac is advancing new immunotherapies that may make a tremendous difference in the ongoing fight against cancer,” said Gerald A. Michaud, President of Horizon. “Through the development of antibody conjugate-based therapeutics, Tallac’s best-in-class therapies attempt to trigger innate and adaptive immune responses to best address the needs of patients. We are pleased to support Tallac’s […]
REZILIENT3 Global First-Line Trial of Zipalertinib Launched in Patients With NSCLC Harboring EGFR Exon 20 Insertion Mutations
“Patients with NSCLC who have EGFR exon 20 insertion mutations are known to have poorer outcomes than those with more common EGFR mutations,1” said Volker Wacheck, MD, PhD, Senior Vice President, Clinical Development, Taiho Oncology, Inc. “Advancing care for this subset of patients with NSCLC is essential to advancing care in NSCLC overall.”
First patient dosed in Pivotal Study of Berubicin for the Treatment of Glioblastoma Multiforme (GBM)
“Enrolling patients in an orphan disease trial is always a challenge, and that’s why we are thrilled with the rate of enrollment in this potentially pivotal study. The robust interest and enthusiasm among our investigators and patients reflect the pressing need to develop treatment options for patients with GBM. Addressing this devastating disease continues to […]
Ph 2 Clinical Studies of BDC-1001 in Patients With HER2-Positive Cancer Initiated
“This is an important milestone for our company that builds on the positive signal of monotherapy activity that we observed in the Phase 1 portion of the study,” said Edith A. Perez, M.D., Chief Medical Officer of Bolt Biotherapeutics. “Despite considerable advances in anti-cancer therapy, HER2-positive tumors remain difficult to treat, and new therapeutic options […]
Retevmo® (selpercatinib) Demonstrated Superior PFS vs a PD-1 Inhibitor + Chemo for Adults with Newly-Diagnosed Advanced or Metastatic RET Fusion-Positive NSCLC
“The LIBRETTO-431 trial aims to answer an important question about the selection of initial treatment for people with advanced RET fusion-positive NSCLC and these results suggest Retevmo should be considered a first-line standard of care,” said David Hyman, M.D., chief medical officer, Loxo@Lilly. “Additionally, this clinically meaningful achievement of improved outcomes underscores the importance of […]
U.S. FDA Grants Orphan Drug Designation to ABM-1310 for the Treatment of Patients with Glioblastoma Harboring BRAF V600 Mutation
“ABM-1310 is an orally administered medicine with high BRAF-mutation selectivity, high water solubility, and high blood-brain barrier permeability. It is one of innovative drugs independently developed by ABM. ABM-1310 is in Phase I studies at multiple clinical sites in the U.S. and China for BRAF V600-mutant advanced solid tumors. The interim result from its U.S. […]
FAILED TRIAL: Phase 3 AXLerate-OC Study of Batiraxcept in Platinum-Resistant Ovarian Cancer failed to meet primary endpoint of PFS improvement
“We are conducting additional analyses on the AXLerate-OC Phase 3 trial to further evaluate the results of this study and determine the best path forward with our two other planned indications in renal cell carcinoma and pancreatic cancer,” said Gail McIntyre, Ph.D., DABT, Aravive’s President and Chief Executive Officer. “We want to thank the patients […]
