Genmab and argenx Enter Partnership to Advance Antibody Therapies in Immunology and Oncology
“Genmab is entering the therapeutic area of immunology and inflammation as a steppingstone to achieving its vision that by 2030, our knock-your-socks-off “KYSO” antibody medicines will be transforming the lives of people with cancer and other serious diseases,” said Jan van de Winkel, Ph.D., Chief Executive Officer, Genmab. “By partnering with argenx, we will be […]
Independent Data Monitoring Committee Recommends Galinpepimut-S REGAL Trial to Continue as Planned
“This positive IDMC review marks another significant milestone in GPS development and builds on the favorable profile of our study drug, galinpepimut-S,” said Angelos Stergiou, MD, ScD h.c., President and Chief Executive Officer of SELLAS. “Enrollment continues in our global Phase 3 REGAL registrational study, which currently remains on track for interim analysis by the […]
Positive Ph 3 Tislelizumab Trial in Advanced Gastric or GEJ Adenocarcinoma announced
“At the recent ASCO GI meeting, we presented results from an interim analysis demonstrating a statistically significant and clinically meaningful improvement in overall survival in the high PD-L1 expression group in RATIONALE 305 and we are pleased that the final analysis demonstrated a significant survival benefit and consistent safety profile in the entire study population,” […]
Positive final results from Ph 2 trial of VB10.16 + atezolizumab in advanced cervical cancer announced
“We are extremely encouraged by the unprecedented data that indicates a doubling of the survival of PD-L1+ patients with advanced cervical cancer compared to treatment alternatives. Not only do we see patients on average live longer, but 7 of the 14 patients who received all treatments are still alive without signs of progression. This is […]
Fast Track Designation for Botensilimab and Balstilimab in Colorectal Cancer
“We are pleased that the FDA has granted Fast Track designation for the combination of botensilimab with balstilimab in patients with non-MSI-H colorectal cancer, recognizing the high unmet medical need in this population,” said Dr. Steven O’Day, Chief Medical Officer of Agenus. “The Fast Track designation offers important benefits, including the potential eligibility for a […]
Quizartinib NDA Review for Patients with Newly Diagnosed FLT3-ITD Positive AML Extended by FDA
“We are continuing to work with the FDA to facilitate completion of their review of the quizartinib new drug application in order to bring this important medicine to patients as soon as possible,” said Mark Rutstein, MD, Global Head, Oncology Clinical Development, Daiichi Sankyo. “Quizartinib was shown to improve overall survival when added to standard […]
Regulatory Applications Accepted Across Three Regions Globally for Abecma for Earlier Use in Adults with Triple-Class Exposed R/R Multiple Myeloma
“Our continued focus on bringing Abecma into earlier lines of treatment demonstrates our commitment to increasing treatment options and improving outcomes for patients living with multiple myeloma,” said Anne Kerber, senior vice president, head of Cell Therapy Development, Bristol Myers Squibb. “This FDA acceptance marks another step forward in our mission by bringing us closer […]
U.S. FDA Accepts for Priority Review sNDA for the Use of Trifluridine/Tipiracil (LONSURF®) in Combination With Bevacizumab for Refractory mCRC
“The poor prognosis for patients with previously treated, late-stage metastatic colorectal cancer has been an ongoing challenge in the oncology community, which has driven our pursuit of a potential new treatment option,” said Volker Wacheck, MD, PhD, Vice President, Clinical Development, Taiho Oncology, Inc. “We believe the combination of trifluridine/tipiracil plus bevacizumab may represent a […]
FDA approves Polivy in combination with R-CHP for people with certain types of 1L DLBCL
“It has been nearly 20 years since a new treatment option has become available to people newly diagnosed with diffuse large B-cell lymphoma,” said Levi Garraway, M.D., Ph.D., Roche’s Chief Medical Officer and Head of Global Product Development. “Today’s decision from the FDA to approve Polivy in combination with R-CHP in this setting brings a […]
Microbiotica Announces Clinical Trial Collaboration with MSD to Evaluate MB097 in Combination with KEYTRUDA in a Ph 1b Clinical Trial in Melanoma
Tim Sharpington, CEO of Microbiotica, said: “We are delighted to be working with MSD, a world leader in immuno-oncology. The treatment of patients with advanced melanoma has been revolutionised by ICIs such as KEYTRUDA® and there is an opportunity to increase the number of patients who can benefit from these treatments. There is growing evidence […]
ESSA Pharma and Janssen to evaluate EPI-7386 in combination with apalutamide and abiraterone acetate plus prednisone in patients with prostate cancer
“We are pleased to have this agreement in place in order to further investigate EPI-7386 in combination with apalutamide and abiraterone acetate plus prednisone in a variety of prostate cancer patient populations,” said David R. Parkinson, President and Chief Executive Officer of ESSA. “Preliminary clinical data from EPI-7386 combination studies with standard-of-care antiandrogens in mCRPC […]
CTRL Therapeutics Launches with $10M Seed Financing to Advance Next-Generation Cell Therapy Platform for the Treatment of Solid Tumors
“The field of cell therapy has been limited by the lack of tools to isolate and expand tumor-reactive cells that are efficacious against solid tumors.” said Shana Kelley, Ph.D., Founder and Chief Technology Officer at CTRL Therapeutics. “This funding enables further optimization and validation of our proprietary technology platform and expansion of our team to […]
Initiation of New Patients on Evobrutinib Paused in the U.S.; Fully Enrolled Phase III Evobrutinib Studies Continue
FDA has placed a partial clinical hold on the initiation of new patients on evobrutinib and patients with less than 70 days exposure to study medication in the U.S. The ongoing, fully-enrolled Phase III EVOLUTION clinical trial program of evobrutinib in relapsing multiple sclerosis (RMS) will continue as planned with all participants remaining on treatment […]
Enrollment completes in Part A of the DeFianCe Study of DKN-01 for the Treatment of Colorectal Cancer Patients
“The completion of enrollment of Part A of the DeFianCe study is an important milestone for the DKN-01 colorectal cancer development program,” said Cynthia Sirard, M.D., Chief Medical Officer of Leap. “We were very pleased with the enthusiasm of our investigators and patients for participating in Part A, which reflects the unmet medical need of […]
Initiation of Ph 1b Study for NXP800 in Platinum-Resistant, ARID1a-Mutated Ovarian Carcinoma announced
“We are excited to announce the initiation of the Phase 1b study in which NXP800 will be tested, for the first time, in patients with a target disease,” said Ron Bentsur, Chairman and Chief Executive Officer of Nuvectis. “The robust preclinical anti-tumor activity of NXP800, coupled with the data from the Phase 1a dose escalation […]
KEYTRUDA + Chemo Significantly Improved OS Compared to Chemo Alone in Patients With Advanced or Unresectable Biliary Tract Cancer
“Biliary tract cancer is rising in incidence worldwide, and unfortunately most patients are diagnosed with this devastating type of cancer at an advanced stage, when the five-year survival rate is less than 5%,” said Dr. Robin Kate Kelley, professor of clinical medicine in the division of hematology/oncology, University of California, San Francisco. “This trial shows […]
mRNA-4157 (V940) + KEYTRUDA combination Demonstrated Superior RFS in Patients With High-Risk Stage III/IV Melanoma Following Complete Resection vs KEYTRUDA
“Today’s results provide further encouragement for the potential of mRNA as an individualized neoantigen therapy to positively impact patients with high-risk resected melanoma,” said Dr. Kyle Holen, M.D. Moderna’s Senior Vice President and Head of Development, Therapeutics and Oncology. “The profound observed reduction in the risk of recurrence-free survival suggests this combination may be a […]
Imfinzi-based treatment before & after surgery reduced the risk of disease recurrence, progression events or death by 32% in resectable NSCLC in the AEGEAN Ph 3 trial
John V. Heymach, MD, PhD, Professor and Chair Thoracic/Head and Neck Medical Oncology, The University of Texas MD Anderson Cancer Center in Houston, Texas, said: “Too many patients with resectable non-small cell lung cancer experience disease recurrence and poor clinical outcomes today. Adding durvalumab both before and after surgery has the potential to become a […]
Positive topline data announced from Part A safety lead-in of THIO-101 Ph 2 trial in advanced NSCLC
“Part A’s safety profile is in sharp contrast with the typical safety profile of chemotherapy treatment where 70-80% of NSCLC patients experience grade 3 and 4 toxicities,” said MAIA’s Chief Medical Officer Mihail Obrocea, M.D. “The next dose levels of THIO in Part B are lower compared to Part A. Based on the initial safety […]
Tecentriq + Avastin reduced the risk of cancer returning in people with adjuvant HCC at high risk of disease recurrence following liver resection in Ph 3 IMbrave050 study
“Four out of five people with HCC who receive surgery with curative intent may still see their cancer return. Thus, an urgent need exists for adjuvant treatments to prevent early recurrence and improve survival rates,” said Levi Garraway, M.D., Ph.D., Chief Medical Officer and Head of Global Product Development. “With Tecentriq plus Avastin already a […]
FDA Accepts Application for KEYTRUDA + Chemo as 1L Treatment for Locally Advanced Unresectable or Metastatic Gastric or GEJ Adenocarcinoma
“The five-year survival rate for patients diagnosed with metastatic gastric cancer is estimated to be only six percent, and eighty percent of patients with locally advanced unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma have HER2-negative disease,” said Dr. Scot Ebbinghaus, vice president, global clinical development, Merck Research Laboratories. “We are committed to working closely […]
Biotheryx Announces Research Collaboration and License Agreement with Incyte for Discovery of Targeted Protein Degraders for Novel Oncology Targets
“We are pleased to embark on this collaboration with Incyte to identify targeted protein degraders for novel oncology targets. Biotheryx and Incyte share a commitment to finding new, transformative treatment options for people living with cancer,” said Philippe Drouet, President and Chief Executive Officer of Biotheryx. “Our PRODEGY platform is designed to increase efficiency in […]
Scorpion Therapeutics and Pierre Fabre to Co-Develop and Commercialize STX-721 and STX-241 for Patients with EGFR Mutant NSCLC
“Our mission is to develop the next generation of transformational therapies and to deliver them to patients worldwide,” said Axel Hoos, M.D., Ph.D., Chief Executive Officer of Scorpion. “Pierre Fabre is the ideal partner to accelerate this vision; a global pharmaceutical company with a robust clinical and commercial footprint in Europe and Asia, and a […]
Genenta Announces Extension of License Agreement with Ospedale San Raffaele to All Solid Tumor Indications
“We are pleased to reaffirm Genenta’s collaboration with OSR by expanding our license agreement and providing our platform access to all solid tumor indications,” said Pierluigi Paracchi, Chief Executive Officer of Genenta. “This agreement will strengthen the breadth of our IP position and confirm options for combination treatments and other potential payloads. Promising preliminary clinical […]
Additional tablet strength of ERLEADA, 240 mg, available now in the United States
“Each person and their cancer are unique and, as such, there is no one-size-fits-all approach to treatment,” said Luca Dezzani, M.D., Vice President, Medical Affairs, Solid Tumor, Janssen Scientific Affairs, LLC. “The availability of 240mg and 60mg strength options of ERLEADA® demonstrates Janssen’s commitment to prostate cancer patients and provides prescribers flexibility in dosing and […]
First Subject Dosed in Ph 1 KisMET-01 Clinical Trial of MYTX-011 for the Treatment of NSCLC
“Today’s announcement of our first subject dosed represents a significant step towards increasing the number of lung cancer patients eligible for treatment using ADCs, including those whose cancers express moderate cMET levels,” said Brian Fiske, PhD, Chief Scientific Officer and Co-Founder at Mythic Therapeutics. “At Mythic, we are focused on our vision of unlocking the […]
First Two US Clinical Investigator Sites for AVA6000 Ph 1 Clinical Study Opened
Neil Bell, Chief Development Officer for Avacta Therapeutics, commented: “This timely opening of these two key US sites, under the expert direction of Dr Tap and Professor Cranmer, is a major milestone in Avacta’s entry strategy into the US with our promising AVA6000 pre|CISION™ lead programme. We share with our US colleagues a clear vision […]
Partial Clinical Hold announced for Ph 1 Study of MT-0169
“Patient safety is our highest priority. The 5 and 10 mcg/kg cohorts have been completed and we have not observed any cardiac adverse events or other serious adverse events at these lower doses. One patient dosed at 5 mcg/kg is in a stringent complete response and is in his seventh month of therapy. We look […]
Clinical Data of KEYNOTE-695 Trial of TAVO™-EP + KEYTRUDA in Patients with Advanced Melanoma Refractory to anti-PD-1 Treatment announced
“Treatment of patients with anti-PD-1 refractory melanoma remains difficult with limited success for immune checkpoint inhibitor combinations and exploratory therapeutic approaches. It is disappointing that review by blinded central readers did not confirm the previously reported results by investigator assessment of the KEYNOTE-695 Phase 2 clinical trial in this patient population. However, we remain optimistic […]
Lynparza and Imfinzi combination improved PFS in newly diagnosed patients with advanced ovarian cancer without tumour BRCA mutations in DUO-O Ph 3 trial
Philipp Harter, Director, Department of Gynaecology and Gynaecologic Oncology, Evangelische Kliniken Essen-Mitte, Germany and principal investigator for the trial, said: “DUO-O showcases the power of academia and industry collaboration in advancing new treatment combinations for patients with ovarian cancer. I’m grateful for the academic cooperative study groups and patients around the world that made this […]
