Ph 3 interim data analysis of RenovoGem therapy for pancreatic cancer patients to be announced
TIGeR-PaC study Principal Investigator, Michael J. Pishvaian, M.D., Ph.D. at Johns Hopkins Medicine, said, “Results from the interim analysis echo the Phase I/II data and observational studies. The TIGeR-PaC clinical trial is ongoing, but it appears RenovoGem enhances patient survival and has fewer side effects than the standard of care treatment that impacts the entire […]
BLA Submission for Lifileucel in Advanced Melanoma completed
Frederick Vogt, Ph.D., J.D., Interim President and Chief Executive Officer of Iovance, stated, “Completing our BLA submission for lifileucel is a critical step forward in our journey to deliver the first individualized, one-time cell therapy for a solid tumor. I would like to acknowledge the patients and physicians who participated in the C-144-01 clinical trial […]
Rolling Submission of NDA to U.S. FDA for Fruquintinib for the Treatment of Refractory mCRC completed
“This FDA submission is a significant milestone for patients in the U.S. with metastatic CRC, one of the most common and deadly cancers in the U.S. and worldwide. Fruquintinib is an important treatment option for patients with metastatic CRC in China, where it has been available to patients since 2018. We look forward to working […]
Libtayo + Chemo Approved by EC for the 1L Treatment of Advanced PD-L1 Positive NSCLC
“Today’s approval considerably expands the number of people in Europe with advanced non-small cell lung cancer who are eligible for Libtayo-based first-line treatment, including those with PD-L1 expression ranges most commonly seen in real-world practice,” said Israel Lowy, M.D., Ph.D., Senior Vice President, Translational and Clinical Sciences, Oncology at Regeneron. “We are proud that Libtayo […]
FDA Converts to Full Approval Indication for KEYTRUDA® for Certain Adult and Pediatric Patients With Advanced MSI-H or dMMR Solid Tumors
“This approval reinforces the important role of KEYTRUDA in certain patients with MSI-Hor dMMR solid tumors facing a variety of cancers,” said Dr. Luis A. Diaz, Jr., head of the Division of Solid Tumor Oncology, Memorial Sloan Kettering Cancer Center. “These data also further underscore the need for biomarker testing to identify patients who may […]
Jounce Therapeutics Enters Into Agreement to Be Acquired by Concentra Biosciences for $1.85 in Cash per Share Plus Contingent Value Rights
Jounce Therapeutics, Inc., a clinical-stage company focused on the discovery and development of novel cancer immunotherapies and predictive biomarkers, today announced it has entered into a definitive merger agreement whereby Concentra Biosciences, LLC will acquire Jounce for $1.85 in cash per share plus a non-tradeable contingent value right (the “CVR”). The $1.85 per share upfront […]
BioNTech and OncoC4 Announce Strategic Collaboration to Co-Develop and Commercialize Novel Checkpoint Antibody in Multiple Solid Tumor Indications
“Despite being a prime target for more than a decade, we believe that targeting CTLA-4 has not reached its full potential in cancer immunotherapy,” said Prof. Ugur Sahin, M.D., Chief Executive Officer and Co-Founder of BioNTech. “The data presented by OncoC4 on their ONC-392 antibody indicate a differentiated safety profile and encouraging clinical activity in […]
Open-Label Arm of Ph 2 KeyVibe-002 Trial of MK-7684A (Coformulation of Vibostolimab and Keytruda) to continue in Previously Treated mNSCLC Patients
“Through different approaches, such as novel combinations and coformulations, we hope to build on the foundation of KEYTRUDA to help even more patients with cancer,” said Dr. Eliav Barr, senior vice president, head of global clinical development and chief medical officer, Merck Research Laboratories. “We are grateful to the patients and investigators for their participation […]
Ph 1b/2 Study initiated to Evaluate Pepinemab + Avelumab in 2L Metastatic Pancreatic Ductal Adenocarcinoma (PDAC) patients
Dr. Zauderer continued, “The hypothesis for evaluating pepinemab in combination with ICIs in PDAC is supported by a robust body of preclinical studies and human clinical data. These data suggest that treatment with the semaphorin 4D (SEMA4D) blocking antibody, pepinemab, may reverse immunosuppression to promote the infiltration and activation of dendritic cells and CD8+ cells […]
Results from INNATE Phase 2 Trial of JTX-8064 and Pimivalimab Demonstrate Deep and Durable Responses in Platinum Resistant Ovarian Cancer
“Following this analysis, we are pleased to see these results demonstrating deep and durable responses in patients, including those with a PD-L1 score of 0%, on a very well tolerated regimen. These results lead us to believe that there is a potential for meaningful clinical benefit with this combination in patients with few durable therapeutic […]
FAILED TRIAL: Ph 2 KeyVibe-002 Trial of MK-7684A (Vibostolimab + Pembrolizumab) in Previously Treated NSCLC patients did not meet primary PFS endpoint
“Through different approaches, such as novel combinations and coformulations, we hope to build on the foundation of KEYTRUDA to help even more patients with cancer,” said Dr. Eliav Barr, senior vice president, head of global clinical development and chief medical officer, Merck Research Laboratories. “We are grateful to the patients and investigators for their participation […]
FDA Orphan Drug Designation for FORE8394 for the Treatment of Primary Brain and CNS Malignancies
“The receipt of Orphan Drug Designation is another important regulatory achievement that reinforces the FDA’s recognition of the potential of FORE8394 to improve clinical outcomes in patients with BRAF-altered brain tumors,” said Stacie Shepherd, M.D., Ph.D., Chief Medical Officer of Fore Biotherapeutics. “This designation will help us continue to expedite the development of our novel […]
BLA Submission for Lifileucel in Advanced Melanoma completed
Frederick Vogt, Ph.D., J.D., Interim President and Chief Executive Officer of Iovance, stated, “Completing our BLA submission for lifileucel is a critical step forward in our journey to deliver the first individualized, one-time cell therapy for a solid tumor. I would like to acknowledge the patients and physicians who participated in the C-144-01 clinical trial […]
Calquence granted first regulatory approval in China for adults with previously treated mantle cell lymphoma
Dave Fredrickson, Executive Vice President, Oncology Business Unit, AstraZeneca, said: “This approval for Calquence offers people living with mantle cell lymphoma in China an effective and tolerable new treatment option to help control their disease. As the first approval in China for Calquence, it is also an exciting step forward for AstraZeneca in blood cancers, […]
Retifanlimab Receives Accelerated FDA Approval for Merkel Cell Carcinoma
“More than a third of patients with MCC present with regional or distant metastases, which are associated with high rates of mortality,” said Dr. Shailender Bhatia, University of Washington and Fred Hutchinson Cancer Center. “The approval of Zynyz offers healthcare providers another first-line treatment option against MCC that can result in durable responses in patients […]
Caris Life Sciences and Incyte Enter Into Broad Precision Medicine Partnership to Advance Incyte’s Oncology Pipeline
“This partnership with Incyte will leverage Caris’ leading molecular science and technology solutions to support Incyte’s oncology research and development efforts,” said David Spetzler, M.S., Ph.D., MBA, President and Chief Scientific Officer of Caris Life Sciences. “The aggregate strength of our platform, which provides patient level DNA and RNA data both in tissue and blood, […]
Volastra Therapeutics in-licenses Clinical Stage KIF18A Inhibitor And Secures $60 Million in Series A Funding To Further Advance Cancer-Focused Pipeline
“We are excited to add sovilnesib to our growing pipeline of CIN-targeted therapeutics which includes our own KIF18A inhibitor, VLS-1488,” said Charles Hugh-Jones, Chief Executive Officer at Volastra.
First Patient Dosed in the I-SPY-P1 TRIAL in Breast Cancer
“Evorpacept is a potentially transformative approach to strengthen the anticancer immune response against breast cancer with minimal added toxicity,” said Laura Esserman, M.D., co-founder of Quantum Leap, Professor of Surgery and Radiology at the University of California San Francisco, CA. “The combination of a novel CD47 blocker with a HER2-directed ADC represents a promising strategy […]
First Patient Dosed in Ph 1b/2a Trial Evaluating Bemcentinib in 1L NSCLC with STK11 Mutations
“Approximately 20% of non-squamous NSCLC patients harbor STK11m and do not currently have effective treatment options,” said Martin Olin, Chief Executive Officer of BerGenBio. “One specific attribute of this group is that they almost all demonstrate high levels of AXL activation. We are elated to have dosed the first patient in our trial and to […]
Tagrisso demonstrated strong OS benefit in the ADAURA Ph 3 trial for adjuvant treatment of patients with early-stage EGFR-mutated lung cancer
Roy S. Herbst, MD, PhD, Deputy Director and Chief of Medical Oncology at Yale Cancer Center and Smilow Cancer Hospital, New Haven, Connecticut, and principal investigator in the ADAURA Phase III trial, said: “These new survival data for osimertinib reinforce the unprecedented ADAURA disease-free survival results and confirm its potential to extend patients’ lives in […]
Imfinzi significantly improved EFS in AEGEAN Ph 3 trial for patients with resectable NSCLC
John V. Heymach, MD, PhD. Professor and Chair Thoracic/Head and Neck Medical Oncology, The University of Texas MD Anderson Cancer Center, said: “Treating patients early with durvalumab both before and after surgery delivers a significant and clinically meaningful benefit in resectable non-small cell lung cancer, where new options are urgently needed to offer patients the […]
FDA Advisory Committee Votes In Favour of the Clinical Benefit of Polivy Combination For People With 1L DLBCL
“Today’s committee decision to recognise the potential of this Polivy combination as a first-line treatment option is important since four in ten people with diffuse large B-cell lymphoma relapse or do not respond to initial treatment,” said Levi Garraway, M.D., Ph.D., Roche’s Chief Medical Officer and Head of Global Product Development. “We believe the clinical […]
FDA Orphan Drug Designation Granted to Batiraxcept for the Treatment of Pancreatic Cancer
“Receiving Orphan Drug Designation is another important milestone for batiraxcept, and it underscores the significant unmet medical need in patients with pancreatic cancer, typically diagnosed at an incurable advanced stage with a 5-year survival rate of 11%1,” said Gail McIntyre, Ph.D., DABT, Chief Executive Officer of Aravive. “Three patients from our P1b trial are still […]
Nubeqa™ (darolutamide) receives EU approval in mHSPC based on Ph 3 ARASENS trial data
“Today’s approval of Nubeqa represents a significant milestone in addressing unmet medical needs for people living with metastatic hormone-sensitive prostate cancer in Europe,” said Christine Roth, Member of the Executive Committee of Bayer’s Pharmaceuticals Division and Head of the Oncology Strategic Business Unit. “We are committed to improving prostate cancer care across all stages of […]
AstraZeneca enters license agreement with KYM Biosciences for CMG901, a Claudin-18.2 antibody drug conjugate
Puja Sapra, Senior Vice President, Biologics Engineering & Oncology Targeted Delivery, Oncology R&D, AstraZeneca, said, “We are excited by the opportunity to accelerate the development of CMG901, a potential new medicine for patients with Claudin18.2-expressing cancers. CMG901 strengthens our growing pipeline of antibody drug conjugates and supports our ambition to expand treatment options and transform […]
Blueprint Medicines to Regain Global Rights to GAVRETO® (pralsetinib) from Roche
“At Blueprint Medicines, we are dedicated to driving innovation and changing outcomes for patients with lung cancer. GAVRETO is an important treatment option for patients with RET fusion-positive lung cancer and other RET-altered cancers, and we are committed to ensuring that patients being treated with GAVRETO in the commercial and clinical trial settings continue to […]
First Patient dosed in Ph 2 Neoadjuvant Clinical Study of (Z)-Endoxifen in Premenopausal Women with ER+/HER2- Breast Cancer
“We are excited to kick-off this important trial, a significant achievement in our development strategy,” said Dr. Steven Quay, Atossa’s President and Chief Executive Officer. “Approximately 78% of breast cancers are ER+ / HER2- and premenopausal women diagnosed with this disease need more effective and tolerable treatment options; specifically new treatments that do not require […]
Updated survival data from Ph 2 trial of Bria-IMT™ + retifanlimab combo in advanced metastatic breast cancer patients announced
“This is working, and it’s working well. We had high hopes going into this clinical read-out, and the survival numbers have even exceeded our expectations. With 9 of 11 women still alive, this has a material impact for the patients and their loved ones, especially since some patients may have had only weeks or months […]
Positive Full Data Results From the Pivotal Ph 3 SIERRA Trial in Patients with Active, R/R AML announced
Dr. Sergio Giralt, Deputy Head, Division of Hematologic Malignancies, Attending Physician, Adult BMT Service at Memorial Sloan Kettering Cancer Center, stated, “The SIERRA trial results are an exciting advancement for older patients with active r/r AML and will be practice changing in how we treat these patients. I am thrilled to see a high percentage […]
Elranatamab Receives FDA and EMA Filing Acceptance with Submissions based on favorable MagnetisMM-3 trial results in patients with R/R multiple myeloma
“Today, multiple myeloma is a fatal hematologic malignancy, with a median survival of just over five years. As an off-the-shelf treatment, BCMA bispecific antibodies are heralding a new treatment paradigm that can greatly impact the lives of people with this disease.” said Chris Boshoff, M.D., Ph.D., Chief Development Officer, Oncology and Rare Disease, Pfizer Global […]
