Positive outcome of the prespecified interim futility analysis for Ph 2b ASCEND trial of LSTA1 + SOC in patients with 1L mPDAC announced
“We are pleased that the IDSMC has recommended that we continue the ASCEND trial without change and we see this as an indication of LSTA1’s potential to improve outcomes for patients and its acceptable safety profile,” stated David J. Mazzo, Ph.D., President and Chief Executive Officer of Lisata. “ASCEND continues to enroll at a rapid […]
Datopotamab deruxtecan plus Imfinzi showed promising clinical activity in the 1L advanced NSCLC setting in TROPION-Lung04 Phase Ib trial
Cristian Massacesi, Chief Medical Officer and Oncology Chief Development Officer, AstraZeneca, said: “Following the positive high-level results of TROPION-Lung01, these initial TROPION-Lung04 results in the first-line setting reinforce our confidence in datopotamab deruxtecan as a potential treatment option for patients with advanced non-small cell lung cancer. Through our robust clinical programme we are eager to […]
Tagrisso plus chemotherapy extended mPFS by nearly 9 months in EGFR-mutated advanced lung cancer in FLAURA2 Phase III trial
Pasi A. Jänne, MD, PhD, medical oncologist at Dana-Farber Cancer Institute and principal investigator for the FLAURA2 trial, said: “Patients received nearly nine additional months before their EGFR-mutated non-small cell lung cancer progressed as a result of the addition of chemotherapy to standard-of-care osimertinib, building on the strong efficacy we have already seen with osimertinib […]
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 […]
Phase III ALINA study of Alecensa® (alectinib), compared with platinum-based chemotherapy, met its primary endpoint of disease-free survival (DFS)
“Alecensa has transformed outcomes for people with advanced ALK-positive NSCLC, and now these strong results provide evidence for the first time that this medicine could also play a pivotal role in early-stage disease where there is significant unmet need,” said Levi Garraway, M.D., Ph.D., chief medical officer and head of Global Product Development. “If approved, […]
Positive Pre-BLA Meeting with FDA for EB-101 and Plans for BLA Submission announced
“We are pleased with the outcome of the pre-BLA meeting for EB-101 and believe that we have aligned with the FDA on what is needed for our upcoming BLA submission,” said Vish Seshadri, Chief Executive Officer of Abeona. “We are focused on gathering and packaging the existing data over the coming weeks to meet the […]
ENHERTU® Granted Two Breakthrough Therapy Designations in U.S. for Patients Across Multiple HER2 Expressing Cancers
“ENHERTU is the first HER2 directed therapy to demonstrate a potential benefit across a series of difficultto-treat cancers and these designations are recognition of the continued potential of this innovative medicine,” said Ken Takeshita, MD, Global Head, R&D, Daiichi Sankyo. “We remain committed to exploring additional opportunities for ENHERTU in these tumor types with the […]
sNDA submitted to FDA for Full Approval of BALVERSA® (erdafitinib) for the Treatment of Patients with Locally Advanced or Metastatic Urothelial Carcinoma
“BALVERSA continues to generate promising clinical findings for patients with FGFR-altered metastatic urothelial cancer, who often face poor disease outcomes,” said Peter Lebowitz, M.D., Ph.D., Global Therapeutic Area Head, Oncology, Janssen Research & Development, LLC. “Through the ongoing development of this targeted therapy, we are committed to transforming bladder cancer treatment to positively impact the […]
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 […]
Calquence approved in China for chronic lymphocytic leukaemia
Professor Li Jianyong, Director of Haematology, People’s Hospital of Jiangsu Province, and Leader of China CLL Working Group, said: “Many people living with chronic lymphocytic leukaemia experience relapse and need additional treatment options to help manage their disease. I’m delighted that with this approval patients now have access to an established treatment that has already […]
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 […]
Positive Results from Phase 3 CONTACT-02 Pivotal Trial of Cabozantinib + Atezolizumab in mCRPC Announced
“These positive findings from CONTACT-02 are highly encouraging given the need for additional, non-cytotoxic or non-chemotherapeutic treatment options for this patient population,” said Neeraj Agarwal, M.D., FASCO, Professor and Presidential Endowed Chair of Cancer Research at Huntsman Cancer Institute, University of Utah and the global lead investigator of the trial. “Cabozantinib in combination with atezolizumab […]
Retevmo® (selpercatinib) Demonstrates Superior PFS Compared to Approved Multikinase Inhibitors in RET-Mutant Medullary Thyroid Cancer
“These data from the LIBRETTO-531 trial confirm the importance of selectivity in targeting RET-driven cancers and suggest Retevmo should be considered the preferred first-line treatment for people with advanced RET-mutant medullary thyroid cancer,” said David Hyman, M.D., chief medical officer, Loxo@Lilly. “Taken together with the recent positive Retevmo Phase 3 LIBRETTO-431 announcement in lung cancer, […]
Update provided on Phase III Skyscraper-01 study in PD-L1-high mNSCLC
“The interim results for the primary endpoint of overall survival were not mature at the time of the second interim analysis, with median overall survival estimates of 22.9 months [95% CI: 17.5, NE] in the tiragolumab plus Tecentriq arm, and 16.7 months [95% CI: 14.6, 20.2] in the Tecentriq monotherapy arm, yielding a hazard ratio […]
FAILED TRIAL: Phase 3 LEAP-010 Trial of LENVIMA + KEYTRUDA in Patients With Certain Types of Recurrent or mSCCHN unlikely to meet primary endpoint of OS
“With the LEAP-010 trial, we aimed to explore whether this combination could improve upon options already available with KEYTRUDA-based regimens for appropriate patients with metastatic or with unresectable, recurrent HNSCC,” said Dr. Gregory Lubiniecki, Vice President, Global Clinical Development, Merck Research Laboratories. “Although the progression-free survival results from this study were encouraging, unfortunately the combination […]
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 […]
sNDA submitted to FDA for Full Approval of BALVERSA for the Treatment of Patients with Locally Advanced/Met Urothelial Carcinoma & Selected FGFR Gene Alterations
“BALVERSA continues to generate promising clinical findings for patients with FGFR-altered metastatic urothelial cancer, who often face poor disease outcomes,” said Peter Lebowitz, M.D., Ph.D., Global Therapeutic Area Head, Oncology, Janssen Research & Development, LLC. “Through the ongoing development of this targeted therapy, we are committed to transforming bladder cancer treatment to positively impact the […]
Application For Lumakras® (Sotorasib) For The Treatment Of KRAS G12C-Positive NSCLC To be Discussed At FDA Advisory Committee Meeting
“We believe in the clinical value of LUMAKRAS for prescribers and patients navigating KRAS G12C-mutated NSCLC and we look forward to discussing the comprehensive data package for LUMAKRAS with members of the Committee,” said David M. Reese, M.D., executive vice president of Research and Development at Amgen.
FDA grants Orphan Drug Designation for NXC-201 as a Treatment for Multiple Myeloma
“We are pleased to receive FDA’s orphan drug designation in multiple myeloma for NXC-201, the only clinical-stage BCMA-targeted CAR-T cell therapy with no neurotoxicity observed in over 50 patients dosed to date,” said Ilya Rachman, MD PhD, Executive Chairman of Nexcella. Dr. Rachman continued, “We are thrilled to potentially expand therapeutic options for multiple myeloma […]
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 […]
Celcuity Enters into a Clinical Trial Collaboration and Supply Agreement with Bayer to Provide Nubeqa® (darolutamide) for Planned Phase 1b/2 Clinical Trial
“We are excited that Bayer is providing darolutamide for this important Phase 1b/2 clinical trial,” said Brian Sullivan, Chief Executive Officer and co-founder of Celcuity. “Darolutamide is structurally unique to other ARI’s, with an excellent efficacy and differentiated tolerability profile coupled with minimal drug-drug interactions, making it an ideal combination partner for gedatolisib. Our goal […]
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.
P201 – A Registrational trial for OT-101 in Pancreatic Cancer initiated
“Over the past years we have been meticulously planning this trial to ensure its success. Spearheaded by our discovery that suppression of TGFβ2 could more than double survival in pancreatic cancer, we have engineered the trial to deliver a decisive win against pancreatic cancer. We look forward to engage physicians and patients in this critically […]
First participant of cohort 4 of the theranostic CL04 trial investigating 64Cu/67Cu SARTATE in neuroblastoma treated
Clarity’s Executive Chairperson, Dr Alan Taylor, commented, “We are very excited to have dosed the first participant in this highest dose level cohort of our theranostic neuroblastoma trial in the US, having successfully completed cohort 3 very recently. We hope that the increase in administered activity between cohorts 3 and cohort 4 will have a […]
