Tecentriq subcutaneous (SC) is approved in Great Britain for all indications of IV Tecentriq, offering a faster, more convenient option to receive treatment
“Cancer immunotherapy has transformed the way we treat cancer. Giving Tecentriq subcutaneously now offers patients a faster and more flexible treatment option and can free up resources for healthcare systems, while maintaining its established safety profile,” said Levi Garraway, M.D., Ph.D., Roche’s Chief Medical Officer and Head of Global Product Development. “We are working with […]
European Commission Approves KEYTRUDA + Trastuzumab and Chemo as 1L Treatment for HER2-Positive Advanced GEJ Adenocarcinoma Expressing PD-L1
“Patients in the EU diagnosed with HER2-positive advanced gastric cancer face an aggressive disease associated with a poor prognosis, underscoring the need for additional first-line treatment options for these patients,” said Dr. Scot Ebbinghaus, vice president, global clinical development, Merck Research Laboratories. “With today’s approval of KEYTRUDA, we’re proud that patients whose tumors express PD-L1 […]
FAILED TRIAL: Ph 3 INNOVATE-3 trial of TTFields + paclitaxel in patients with platinum-resistant ovarian cancer did not meet its primary endpoint of OS
“Recurrent ovarian cancer is a particularly aggressive cancer and options for patients diagnosed with platinum-resistance remain extremely limited,” said Ignace Vergote, MD, PhD, Principal Investigator and Chairman of the Belgium and Luxembourg Gynaecological Oncology Group and Professor at the Catholic University of Leuven, Belgium. “We are committed to continuing research with TTFields and exploring innovative […]
Positive Results from Phase 3 CABINET Pivotal Trial Evaluating Cabozantinib in Advanced Pancreatic and Extra-Pancreatic Neuroendocrine Tumors Announced
“As there is no standard of care for patients with advanced pancreatic or extra-pancreatic neuroendocrine tumors whose disease has progressed after prior therapy, we are pleased to see that cabozantinib improved outcomes for two additional patient populations living with advanced, difficult-to-treat cancers,” said Will Berg, M.D., Senior Vice President, Medical Affairs, Exelixis. “We are grateful […]
FDA Grants Priority Review for XTANDI® in Non-Metastatic Castration-Sensitive Prostate Cancer with High-Risk Biochemical Recurrence
“The FDA’s granting of a Priority Review designation reinforces the need to bring new treatment options for patients with high-risk biochemical recurrent nmCSPC,” said Chris Boshoff, M.D., Ph.D., Chief Oncology Research and Development Officer, Executive Vice President, Pfizer. “We believe the EMBARK data demonstrate the potential of XTANDI, if approved, to help patients earlier in […]
sBLA submitted to FDA for RYBREVANT® (amivantamab-vmjw) + Chemotherapy for 1LTreatment of Patients with EGFR Exon 20 Insertion Mutation-Positive mNSCLC
“PAPILLON is the first randomized Phase 3 study in patients with NSCLC with EGFR exon 20 insertion mutations to show clinically meaningful results. This creates an opportunity to make a significant improvement to the standard of care for this patient population with high unmet medical need,” said Kiran Patel, M.D., Vice President, Clinical Development, Solid […]
Lack of ethnic diversity in Alzheimer’s disease clinical trials – how patients of color get side-lined.
Under-representation of people of color in clinical trials is a long-standing problem in medical research with far-reaching consequences on research outcomes and equity towards access to treatments. Clinical trials on the newly approved Alzheimer’s disease (AD) drug, Leqembi and Eli Lilly’s Donanemab, currently awaiting FDA’s decision, have both been criticized (1) for having less diverse […]
CARsgen Collaborates with Moderna to Evaluate CT041 in Combination with an mRNA Cancer Vaccine
“CT041 is the most advanced solid tumor CAR-T in development (pivotal phase II) and continues to show promise in treating gastric and pancreatic cancers. In our quest to make cancer curable, we are continuously exploring multiple modalities to eradicate tumors. Attacking tumors with CAR T-cell therapy in combination with a cancer vaccine could potentially provide […]
Verastem Oncology Enters Discovery and Development Collaboration with GenFleet Therapeutics to Advance New Programs Targeting RAS Pathway-Driven Cancers
“With the aim of bringing needed therapies to patients where there is high unmet medical need, we are looking forward to working with GenFleet on this important discovery and development collaboration,” said Dan Paterson, President and Chief Executive Officer of Verastem Oncology. “This synergistic collaboration augments our research and development pipeline in alignment with our […]
IDMC Recommends Galinpepimut-S REGAL Trial to Continue Without any Modifications
“At its most recent meeting, we were pleased that the IDMC positively commented on the high level of study integrity and conduct, as well as the rate of enrollment to date. We look forward to the anticipated completion of enrollment in Q4, as well as the subsequent interim analysis, both significant milestones for our GPS […]
First participant of cohort 3 in the theranostic SECuRE trial investigating 64Cu/67Cu SAR-bisPSMA in mCRPC treated at the highest dose level of 12GBq
Clarity’s Executive Chairperson, Dr Alan Taylor, commented, “Results from cohort 2 are incredibly exciting and we look forward to seeing data from the increased dosing of 12GBq as well as discover the potential positive effects of multi-dosing on prostate cancer patients.
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. […]
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 […]
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 […]
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 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 […]
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 […]
