KEYNOTE-991 Trial Evaluating KEYTRUDA® Plus Enzalutamide and Androgen Deprivation Therapy in Patients With mHSPC to Stop for Futility
“There is a significant unmet need for patients with advanced prostate cancer, and the outcome of this study is an important reminder that this disease remains very difficult to treat,” said Dr. Scot Ebbinghaus, vice president, clinical research, Merck Research Laboratories. “We are grateful to the patients and investigators for their participation in this study, […]
Ongoing MGTA-117 Ph 1/2 Dose-Escalation Clinical Trial in R/R AML and MDS paused
TRANSCEND CLL 004 Trial of Breyanzi® (lisocabtagene maraleucel) Met Primary Endpoint of Complete Response Rate in R/R CLL Patients
“CLL is an incurable disease with complex biology and immune dysregulation that has made the development of T cell-based therapies that provide deep remission very challenging,” said Anne Kerber, senior vice president, head of Cell Therapy Development, Bristol Myers Squibb. “In a population that has limited options, the TRANSCEND CLL 004 study represents the first […]
Ph 3 CARTITUDE-4 Study of CARVYKTI® (cilta-cel) meets Primary Endpoint in Patients with Relapsed and Refractory Multiple Myeloma
“The CARTITUDE-4 study represents the first Phase 3 program in our comprehensive clinical development strategy for CARVYKTI, and further demonstrates our commitment to advance the treatment of patients with relapsed/refractory multiple myeloma,” said Jordan Schecter, M.D., Vice President, Clinical Development Cellular Therapy Program, Janssen Research & Development, LLC. “We look forward to the presentation of […]
Fast Track Designation from the FDA for Tamibarotene for the Treatment of Higher-Risk Myelodysplastic Syndrome
“Receipt of Fast Track designation for tamibarotene underscores both the potential of tamibarotene and the unmet need for HR-MDS patients, who have a poor prognosis due to the progressive nature of the disease,” said David A. Roth, M.D., Chief Medical Officer of Syros Pharmaceuticals. “No new therapies beyond hypomethylating agents have been approved since 2006, […]
IND cleared for SC291, a Hypoimmune-modified, CD19-targeted Allogeneic CAR T Therapy for Patients with B-Cell Malignancies
“The clearance of our SC291 IND is an important milestone, putting us closer to our goal of making an important medicine for patients with B-cell lymphomas and leukemias,” said Steve Harr, Sana’s President and CEO. “We look forward to understanding the safety, potency, and persistence of these cells in patients, and we are optimistic that […]
FDA Accelerated Approval of TUKYSA® (tucatinib) in Combination with Trastuzumab for People with Previously Treated RAS WT, HER2-Positive mCRC
“Historically, patients with HER2-positive metastatic colorectal cancer who have progressed following frontline therapy have had poor outcomes,” said John Strickler, M.D., associate professor of medicine, Duke University Medical Center, and lead investigator for the MOUNTAINEER trial. “The FDA approval of a chemotherapy-free combination regimen that specifically targets HER2 is great news for these patients.”
FDA Approves KEYTRUDA® as Adjuvant Treatment Following Surgical Resection and Platinum-Based Chemotherapy for Patients With Stage IB, II, or IIIA NSCLC
“While there have been many advances for patients with metastatic disease, surgery remains the typical treatment for people with stage IB, II and IIIA non-small cell lung cancer. Unfortunately, many of these patients who undergo surgery still see their disease return,” said Roy S. Herbst, M.D., Ph.D., deputy director and chief of medical oncology, Yale […]
Sonnet BioTherapeutics Announces a Collaboration with Roche for the Clinical Evaluation of SON-1010 with atezolizumab in Ovarian Cancer
“As this is Sonnet’s first combination clinical study and an opportunity to use our lead FHAB-derived candidate, SON-1010, with atezolizumab, it is a very important milestone for the company. We believe that the combination of our best-in-class IL12-FHAB immune-enhancer candidate with atezolizumab could enable the next generation of cancer treatment.” said Pankaj Mohan, Ph.D., Sonnet’s […]
Kronos Bio Announces Discovery Collaboration with Genentech to Advance Novel Therapies Against Transcriptional Targets in Oncology
“This, our first collaboration, brings together expertise from both companies with the goal of answering fundamental scientific questions about the biology of cancer that we hope will one day lead to the advancement of new clinical candidates,” said Norbert Bischofberger, Ph.D., president and chief executive officer of Kronos Bio. “We are pleased to be able […]
Randomization in PNT2002’s Ph 3 SPLASH Trial Completed
“We are proud to have reached this important milestone for the PNT2002 program,” said Jessica Jensen, Executive Vice President, Clinical Development of POINT Biopharma. “Our incredibly talented cross-functional team collaborated tirelessly to ensure that, despite the extraordinary circumstances of a pandemic, POINT’s first phase 3 global trial remained on track. Our success is a testament […]
First patient dosed with B4t2-001 CAR-T targeting solid tumors
“This first-in-human study marks the initial therapeutic to be evaluated from Bio4t2’s technology,” said Dr. Laurence Cooper MD-PhD, Executive Chairman of the board. “PrismCore is capable of rapidly generating CAR-T to safely target self-antigens, opening a new frontier to delivering CAR-T to treat many types of solid tumors. This clinical trial is at the cutting […]
Results of the First Post-Commercial Utilization Review of JELMYTO® Provide New Evidence that Reinforces its Efficacy and Safety in Patients with Low-Grade Upper Tract Urothelial Cancer
“This study provides valuable insights into how physicians are utilizing JELMYTO in the real-world and reinforces the genuine clinical value of this therapy for patients with LG-UTUC,” said Mark Schoenberg, M.D., Chief Medical Officer, UroGen. “We look forward to additional analyses from this retrospective study as well as prospective and retrospective data from the uTRACT […]
Promising Top-Line Results from Ph 2 Trial of BXCL701 in small cell neuroendocrine metastatic castration-resistant prostate cancer (SCNC) patients announced
“We are pleased that BXCL701 in combination with pembrolizumab has demonstrated an encouraging response rate in this difficult-to-treat cancer with no currently approved FDA therapies,” said Vincent J. O’Neill, M.D., Chief R&D Officer, OnkosXcel Therapeutics, a wholly owned subsidiary of BioXcel Therapeutics. “BXCL701’s promising profile as an oral innate immune activator with a large safety […]
Leukemia Drug Lumoxiti to be withdrawn From US Market
Fast Track Designation Granted by the FDA to CFI-402257 for the Treatment of ER+/HER2- Breast Cancer
“There is an urgent need for new, safe and efficacious therapies to treat ER+/HER2- breast cancer, particularly when standard of care regimens fail,” said Dr. Mark Bray, Treadwell CSO and Co-founder. “CFI-402257 has shown early signs of durable activity with a manageable safety profile, as a monotherapy and in combination with fulvestrant in ER+/HER2- breast […]
Triumvira Immunologics and Merck to Evaluate TAC01-HER2 Cell Therapy + KEYTRUDA® in Patients with HER2-positive Solid Tumors
“We believe the addition of an immune checkpoint inhibitor, such as KEYTRUDA, to TAC01-HER2 will effectively release inhibitory PD-L1/PD1 signaling in T cells, potentially leading to improved and durable therapeutic responses, said Paul Lammers, M.D., M.Sc., Chief Executive Officer of Triumvira. We are pleased to work collaboratively with Merck to explore the potential of this […]
Nouscom and MSD to Evaluate NOUS-209 + KEYTRUDA® in a Ph 2 Randomized Trials in dMMR/MSI-High Metastatic Colorectal Cancer
Dr Marina Udier, Chief Executive Officer of Nouscom, added: “We are thrilled to collaborate with MSD, a global leader in immuno-oncology, and to work with their highly experienced and talented clinical development team, allowing us to accelerate the ongoing US and EU Phase 2 trial with NOUS-209. Based on our published and presented Phase 1 […]
Enrollment Completed in the Global Registrational Ph 3 AXLerate-OC Trial for Platinum-Resistant Ovarian Cancer
“Completing enrollment of this pivotal study brings us closer to the day when batiraxcept potentially is available to patients,” said Scott Dove, Ph.D., Chief Operating Officer of Aravive. “Public reporting of topline data remains on track for mid-2023 and, if successful, are expected to support a Biologics License Application for PROC at the end of […]
50% Enrollment completed in Randomised Ph IIb TACTI-003 Trial for 1L Head & Neck Cancer
Marc Voigt, CEO of Immutep stated: “We are pleased to reach this important milestone and extend our sincere appreciation to our investigators, clinical team, partners, and most importantly patients, that have participated in this study. As clinical evidence showing the compelling benefits of combining efti with immune checkpoint therapies such as pembrolizumab continues to grow, […]
Positive Top-line Results from Pivotal Ph 3 Trial of TAVT-45 for the Treatment of Metastatic Prostate Cancer Announced
“The positive results from the TAVT45C02 trial demonstrate that TAVT-45 may provide an easy-to-swallow alternative to Zytiga®, benefitting many patients with dysphagia or difficulty swallowing large tablets,” said Andreas Maetzel, M.D. Ph.D., chief medical officer of Tavanta Therapeutics. “Approximately 20 to 30 percent of cancer patients, including many patients with prostate cancer, have difficulty swallowing […]
Pivotal LUNAR Study of TTFields + SoC in NSCLC Met Primary Overall Survival Endpoint
“We are pleased with the positive readout of the LUNAR study. Prior to LUNAR, the last phase 3 trial to lead to significant improvement in overall survival in late-stage, platinum-resistant non-small cell lung cancer was six years ago, underlining the difficulty in treating this disease,” said William Doyle, Novocure’s Executive Chairman. “We are also pleased […]
BT8009 Gets FDA Fast Track Designation To Treat Urothelial Cancer
“FTD represents another positive step in the development of BT8009 and reflects the pressing need for a clinically meaningful, differentiated therapy compared to what is available for patients,” said Kevin Lee, Ph.D., Chief Executive Officer. “We believe this designation is a valuable component of our future clinical and regulatory strategy as we work to align […]
FDA Grants Priority Review to Glofitamab for People with Relapsed or Refractory Large B-Cell Lymphoma
“Unfortunately, people with relapsed or refractory large B-cell lymphoma have a poor prognosis and desperately need additional therapies that are immediately available at the time of relapse,” said Levi Garraway, M.D., Ph.D., Roche’s Chief Medical Officer and Head of Global Product Development. “Even for patients whose cancer is rapidly progressing, glofitamab given for a fixed […]
Patient dosing stopped in MGTA-117 Ph 1/2 Dose Escalation Clinical Trial in R/R AML and MDS
“Magenta Therapeutics today announces that, per the clinical trial protocol for the MGTA-117 Phase 1/2 Dose Escalation Clinical Trial in relapsed/refractory acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS), it has stopped dosing participants at the Cohort 4 dosing level (0.13 mg/kg) and plans to dose additional participants at the Cohort 3 dosing level (0.08 […]
Merck and Kelun-Biotech Announce Exclusive License and Collaboration Agreement for 7 Investigational ADC Candidates for the Treatment of Cancer
“Advances in ADC technologies are yielding a new generation of candidates designed to more precisely target and deliver potent anticancer agents to the tumor site,” said Dr. Dean Y. Li, president, Merck Research Laboratories. “We continue to augment our oncology pipeline and look forward to working with the Kelun-Biotech team to advance these candidates to […]
Kite To Acquire Tmunity Therapeutics To Pursue Next Generation CAR T-Cell Therapy Advancements In Cancer
“Kite has demonstrated an ability to globally scale cell therapy and address the unique challenges and opportunities that cell therapy represents, which are quite different in material ways than traditional pharmaceutical or biotech approaches,” said Tmunity Founder Carl June, MD, who is also the Richard W. Vague Professor of Immunotherapy in Penn’s Perelman School of […]
First Patient Dosed in PRESERVE-004 Ph 2 Clinical Trial of ONC-392 + KEYTRUDA® in Patients with Platinum-Resistant Ovarian Cancer
“We are pleased to be making progress on our ONC-392 clinical program with the dosing of our first patient in the PRESERVE-004 trial in the combination arm with KEYTRUDA. We are hopeful these results will build on the promising responses we’ve seen with ONC-392 as monotherapy,” said Pan Zheng, M.D., Ph.D. Chief Medical Officer and […]
mOS of 21 Months in Advanced, Refractory Cancer Patients observed in Ph 2 trial of PDS0101-based triple combination therapy in advanced HPV-positive cancers
“The expanded data continue to demonstrate the durability and tolerability of the PDS0101-based triple combination therapy in advanced HPV-positive cancers, an extremely challenging population of refractory and previously untreatable HPV-positive patients,” stated Dr. Frank Bedu-Addo, President and Chief Executive Officer of PDS Biotech. “We are pleased to see the continued consistency in the data with […]
Positive Topline Data in Ph 2 Pivotal HERIZON-BTC-01 Trial of Zanidatamab announced
“We are thrilled to report these positive topline data from the HERIZON-BTC-01 clinical trial, which further support the potential of zanidatamab as a new chemotherapy-free therapeutic option for HER2-amplified and expressing BTC. These data demonstrate that zanidatamab, as a single agent, improves on the current standard of care for patients in a difficult-to-treat disease who […]
