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 […]
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 […]
FDA sends CRL for LYMPHIR™ (Denileukin Diftitox) for the Treatment of Patients with R/R Cutaneous T-Cell Lymphoma
“We appreciate the FDA’s expeditious review of our application. We intend to provide additional data and remain fully engaged with the FDA as we continue to work toward approval. We remain confident in the potential of LYMPHIR to become an important addition to the treatment landscape for patients with relapsed or refractory CTCL and make […]
European Commission Approves LONSURF® (Trifluridine/tipiracil) in Combination With Bevacizumab in 3rd Line Refractory mCRC
“The approval by the European Commission is supported by data from the phase 3 SUNLIGHT trial for patients suffering from an advanced colorectal cancer who have already failed two prior chemotherapy regimens. The Marketing Authorization covers the 27 countries of the European Union as well as Iceland, Northern Ireland, Liechtenstein and Norway.”
Jemperli (dostarlimab) + chemo approved in the US as 1L treatment for dMMR/MSI-H primary advanced or recurrent endometrial cancer
Hesham Abdullah, Senior Vice President, Global Head of Oncology Development, GSK, said: “Today’s expanded approval of Jemperli redefines the treatment landscape for patients with dMMR/MSI-H primary advanced or recurrent endometrial cancer. Until now, chemotherapy alone has been the standard of care with many patients experiencing disease progression. In the RUBY trial, Jemperli plus chemotherapy demonstrated […]
Immatics Announces $35 Million Equity Investment from Bristol Myers Squibb
“This investment is further testimony to the strength of the relationship and of our differentiated platform technologies that are the foundation of our TCR-based cell therapies and bispecifics,” commented Harpreet Singh, Ph.D., CEO and Co-Founder of Immatics. “We remain steadfast in our commitment to advancing innovative treatment options for patients in their fight against cancer, […]
ImmunoGen Announces Multi-Target License and Option Agreement with ImmunoBiochem to Develop Next-Generation ADCs
“We are excited to partner with ImmunoBiochem, which brings a novel approach to tumor targeting for ADCs,” said Eric Westin, ImmunoGen’s Vice President of Clinical Development and Translational Sciences. “This agreement reflects our commitment to leverage our rich IP portfolio through strategic partnering in order to further reinvigorate our research and development in support of […]
Phase 3 Study of V940 (mRNA-4157) + KEYTRUDA initiated for Adjuvant Treatment of Patients with Resected High-Risk (Stage IIB-IV) Melanoma
“As we continue our efforts to advance novel treatment options for patients with high-risk Stage IIB-IV melanoma, the initiation of the V940-001 Phase 3 trial represents an important step forward in these efforts and our study of individualized neoantigen therapy,” said Dr. Marjorie Green, senior vice president and head of late-stage oncology, global clinical development, […]
Phase 3 ENHANCE Study of Magrolimab Plus Azacitidine in Higher-Risk MDS To Discontinue
“The health and well-being of patients are our top priorities and while this is disappointing news it confirms the challenges of treating HR-MDS, where no new class of treatments have been approved in nearly 20 years,” said Merdad Parsey, MD, PhD, Chief Medical Officer, Gilead Sciences. “Gilead is deeply grateful to the patients, families, investigators, […]
Topline Data from UPLIFT Clinical Trial in Patients with Platinum-Resistant Ovarian Cancer and Strategic Reprioritization Announced
“We are deeply disappointed that UPLIFT’s efficacy failed to replicate previous data from approximately 100 patients in the dose expansion portion of our Phase 1b clinical trial,” said Dr. Arvin Yang, Senior Vice President and Chief Medical Officer of Mersana Therapeutics. “While the duration of response was longer than that from the dose expansion portion […]
UGN-102 Met Primary Endpoints in Both Phase 3 ATLAS and ENVISION Clinical Trials in NMIBC patients
“UGN-102 has demonstrated a robust and consistent therapeutic profile across multiple clinical trials, providing a compelling picture of its potential to be a transformational product and advance the standard of care away from repetitive surgery to a minimally invasive, non-surgical option for LG-IR-NMIBC,” says Liz Barrett, President and Chief Executive Officer of UroGen. “If approved, […]
FDA Grants Fast Track designation to IVS-3001 for the Treatment of Renal Cell Carcinoma
“We are thrilled to receive the FDA’s Fast Track designation for IVS-3001, said Dr. Jake Kushner, CEO of Invectys. “This recognition further validates the potential of our CAR-T cell therapy in revolutionizing cancer treatment for patients with solid tumors. The dedicated team at Invectys, as well as our partners, are committed to bringing this innovative […]
EMA Approves Clinical Trial Application (CTA) for AVC-201 for the Treatment of R/R AML and other CD123 Hematological Malignancies
“We are excited to build on the early success and promising activity and safety of our ongoing switchable autologous clinical program in AML (AVC-101) by now including what we believe is the most scientifically-compelling allogeneic technology in the industry,” said Andrew Schiermeier, AvenCell’s President & CEO. “With the application of both platform technologies, we are […]
European Commission Approves Trodelvy For Pre-Treated HR+/HER2- Metastatic Breast Cancer
“The European approval of sacituzumab govitecan is an important milestone for the European breast cancer community,” said Dr. Javier Cortes, Head of the International Breast Cancer Center, in Madrid and Barcelona, Spain. “We now have a new treatment option that has delivered a proven and clinically meaningful survival benefit for women in Europe with pre-treated […]
LEQEMBI approved by FDA for early Alzheimer’s disease treatment
The U.S. Food and Drug Administration (FDA) has now approved LEQEMBI under the traditional pathway making it the first approved treatment for early AD with a significant reduction in disease progression rate and slowing cognitive and functional decline. It marks Eisai’s success in research collaboration with Biogen and BioArctic for joint development and commercialization of […]
LianBio Partner NANOBIOTIX Enters into License Agreement with Janssen for NBTXR3, with LianBio Retaining Development and Commercialization Rights in Greater China, South Korea, Singapore and Thailand
“Data generated to date suggest NBTXR3 has potential to address the treatment limitations of standard of care radiotherapy across multiple solid tumor indications,” said Yizhe Wang, Ph.D., Chief Executive Officer of LianBio. “We believe Nanobiotix’s collaboration with Janssen will provide additional expertise and financial resources to broadly develop NBTXR3 in areas of high unmet medical […]
First Patient Dosed with ELU001 in Expansion Cohort of Phase 1/2 Clinical Trial
“This is a notable milestone for the company, as we continue to progress our lead CDC candidate, ELU001, in this important Phase 1/2 trial. The safety data to date has been differentiating for ELU001 when compared to ADCs, including those targeting the same folate receptor alpha target, and we look forward to presenting ELU001 clinical […]
Ph 3 ENHANCE Study Of Magrolimab Plus Azacitidine In Higher-Risk MDS To Discontinue
“The health and well-being of patients are our top priorities and while this is disappointing news it confirms the challenges of treating HR-MDS, where no new class of treatments have been approved in nearly 20 years,” said Merdad Parsey, MD, PhD, Chief Medical Officer, Gilead Sciences. “Gilead is deeply grateful to the patients, families, investigators, […]
KEYTRUDA + Trastuzumab + Chemo Met Primary Endpoint of PFS as 1L Treatment in Patients With HER2-Positive Advanced GEJ Adenocarcinoma
“These new data from KEYNOTE-811, demonstrating a significant improvement in progression-free survival, are meaningful and build on the earlier insights from this study that supported the accelerated approval of this KEYTRUDA combination in the U.S. for certain patients with HER2-positive gastric or GEJ adenocarcinoma,” said Dr. Scot Ebbinghaus, vice president, global clinical development, Merck Research […]
