European Commission granted approval to AKEEGA® (Niraparib & Abiraterone Dual Action Tablet) for the Treatment of Patients with mCRPC with BRCA1/2 Mutations
“Metastatic castration-resistant prostate cancer remains a lethal disease, with high unmet needs in terms of treatment options, particularly for patients with BRCA1/2 gene mutations,” said Professor Gerhardt Attard, Oncologist, University College London (UCL), London, UK*. “We’ve seen that in these patients, niraparib combined with abiraterone acetate and predniso(lo)ne (AAP) significantly reduced the risk of disease […]
Coeptis Therapeutics Signs Agreement to Acquire Allogeneic Immuno-Oncology NK Platform in Phase 1 Clinical Trials from Deverra Therapeutics
“This transaction would greatly expand Coeptis’ technology portfolio by incorporation of a cutting-edge allogeneic cell therapy platform with extensive safety and clinical data and align itself with leading experts in the field of cell and gene therapy,” said Dave Mehalick, President and CEO of Coeptis Therapeutics. Mr. Mehalick continued, “The addition of these clinical and […]
Tubulis Announces Strategic License Agreement with Bristol Myers Squibb to Develop Next Generation ADCs for the Treatment of Cancer Patients
“This strategic agreement with Bristol Myers Squibb is an important validation of the potential of our approach in developing next-generation ADC-based therapeutics and our cutting-edge ADC conjugation technologies that accommodate advanced ADC design to tackle tumors with high-unmet medical need,” said Dominik Schumacher, PhD, CEO and co-founder of Tubulis. “We are committed to transforming oncology […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
IMBRUVICA’s U.S. Accelerated Approvals for Mantle Cell Lymphoma and Marginal Zone Lymphoma Indications to be voluntarily withdrawn
“We fully support the FDA accelerated approval pathway, which patients rely on for timely access to promising treatments that may improve or extend their lives. While withdrawing these indications was a difficult decision, we remain confident in the benefit/risk profile of IMBRUVICA in its approved indications and are committed to its continued development,” said Craig […]
mRNA-4157/V940 (mRNA Cancer Vaccine + KEYTRUDA) Receives PRIME Scheme Designation from the EMA for Adjuvant Treatment of Patients with High-Risk Stage III/IV Melanoma Following Complete Resection
“Prime scheme designation for mRNA-4157/V940 in combination with KEYTRUDA highlights the potential promise of individualized cancer treatments in a population with limited alternatives,” said Stephen Hoge, M.D., Moderna’s President. “There is a high unmet need for therapies in melanoma, as it can be a life-threatening condition where available therapies may not be sufficiently effective in […]
FDA Approves KEYTRUDA + Padcev combination for 1L Treatment of Certain Patients With Locally Advanced or Metastatic Urothelial Cancer
“This approval is a major milestone in the treatment of patients with locally advanced or metastatic urothelial carcinoma because it is the first approved combination of an immunotherapy and an antibody-drug conjugate for these patients,” said Dr. Eliav Barr, senior vice president, head of global clinical development and chief medical officer, Merck Research Laboratories. “This […]
Coeptis Therapeutics Secures Exclusive Rights to Negotiate to Acquire Transformational Cell Therapy Platform to Enable Potent Combinatorial IO Treatment Strategies
“We believe that the acquisition of VyGen-Bio’s GEAR Platform would represent a significant inflection point in the growth of Coeptis and our strategy to be a leader in the development of ‘next generation’ cell therapy technologies for cancer and other diseases,” said Dave Mehalick, President and CEO of Coeptis Therapeutics. “Our vision for GEAR is […]
Omega Enters Supply Agreement With Roche To Evaluate OTX-2002 In Combination With Atezolizumab in HCC
“This agreement with Roche represents continued execution of our clinical trial strategy and the next step toward realizing the transformative potential of OTX-2002, a first-in-class epigenomic controller designed to pre-transcriptionally downregulate the MYC oncogene, a historically undruggable target,” said Mahesh Karande, President and Chief Executive Officer of Omega Therapeutics. “In preclinical studies, OTX-2002 demonstrated synergistic […]
Ph 3 Study Evaluating PDS0101 + KEYTRUDA in Head and Neck Cancer to Initiate in 2023
“With the maturing data from VERSATILE-002, we are pleased to now have visibility into the progression free survival and potential overall survival, and we are excited to move into the final stage of development for our lead asset, PDS0101. The initiation of a randomized, controlled Phase 3 registrational trial of PDS0101 in combination with KEYTRUDA® […]
Lift of Partial Clinical Hold on Ph 1/2 VELA Trial of BLU-222 announced
“With a focus on patient safety, we have worked diligently with the FDA over the last several weeks to resolve the partial clinical hold by updating adverse event monitoring and management procedures. We will now collaborate closely with investigators to resume patient enrollment,” said Becker Hewes, M.D., Chief Medical Officer at Blueprint Medicines. “We are […]
Interim results from Part 1 of Ph 3 RUBY trial of Jemperli + chemo in adult patients with primary advanced or recurrent endometrial cancer announced
Hesham Abdullah, Senior Vice President, Global Head of Oncology Development, GSK said: “These positive results from the RUBY trial bring us one step closer to addressing the significant unmet needs of endometrial cancer patients and add to the growing body of evidence on dostarlimab, strengthening our belief in its potential to transform cancer treatment as […]
