FAILED TRIALS: Ph 3 LEAP-003 trial of KEYTRUDA + LENVIMA in 1L metastatic melanoma to be discontinued; combo’s Ph 3 LEAP-017 trial in 1L pMMR mCRC didn’t meet primary endpoint of OS improvement
“With the LEAP-003 and LEAP-017 trials, we set out to help improve outcomes for patients with two difficult-to-treat advanced cancers, melanoma and colorectal cancer,” said Corina Dutcus, M.D., Senior Vice President, Clinical Development, Oncology at Eisai Inc. “While these results are different from our initial expectation, insights from both studies will help contribute to our […]
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U.S. Accelerated Approvals for Mantle Cell Lymphoma and Marginal Zone Lymphoma Indications to be voluntarily withdrawn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 Accepts sNDAs for BRAFTOVI + MEKTOVI in patients with mNSCLC with a BRAF V600E mutation
“For more than a decade, Pfizer Oncology has been at the forefront of bringing biomarker-driven treatment options to patients with cancer. Since their initial regulatory approvals, BRAFTOVI and MEKTOVI have helped improve outcomes in their respective indications of BRAF-mutated metastatic melanoma and BRAF-mutated metastatic colorectal cancer,” said Chris Boshoff, M.D., Ph.D., Chief Development Officer, Oncology […]
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 […]
Jounce Therapeutics Enters Into Agreement to Be Acquired by Concentra Biosciences for $1.85 in Cash per Share Plus Contingent Value Rights
“In conjunction with the merger agreement, Jounce is implementing a workforce reduction of approximately 84% of its employees. This reduction is expected to be completed within the next month and Jounce will incur restructuring costs totaling approximately $6.5 million1. The remaining Jounce employees will work to complete the sale of the Company, conduct activities to […]
Bicycle Therapeutics Announces a Strategic Collaboration with Novartis to Discover, Develop and Commercialize Bicycle® Radio-Conjugates
“This collaboration builds on the groundbreaking clinical work we have been doing in the toxin conjugate field and provides new and additional validation for this unique technology,” said Kevin Lee, Ph.D., Chief Executive Officer of Bicycle Therapeutics. “We look forward to working closely with Novartis to pioneer the discovery and development of potential new cutting-edge […]
Boehringer Ingelheim And Covant To Collaborate On Cancer Immunotherapies
“ADAR1 is an exciting immuno-oncology target with significant therapeutic potential,” said Lamine Mbow, Global Head of Cancer Immunology & Immune Modulation, Boehringer Ingelheim. “We are committed to transforming the lives of cancer patients by delivering meaningful advances with the ultimate goal of curing a range of cancers. By partnering with Covant’s exceptional scientific team and […]
AstraZeneca completes agreement with KYM for CMG901
“AstraZeneca has entered into an exclusive global license for the research, development, manufacture and commercialisation of CMG901 for an upfront payment of $63m, with potential development and sales-related milestone payments of up to $1.1bn and tiered royalties up to low double digits.”
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 […]
First Patient dosed in the CaMMouflage Ph 1 Trial of CB-011 for the Treatment of Relapsed or Refractory Multiple Myeloma
“We are excited to announce the first patient has been treated with CB-011 in the CaMMouflage Phase 1 trial for relapsed or refractory multiple myeloma,” said Rachel Haurwitz, PhD, Caribou’s president and chief executive officer. “Initiation of the CaMMouflage trial is the first step in evaluating the safety of CB-011 and assessing how our immune […]
Dose Expansion Portion of CB-010 ANTLER Ph 1 Trial in 2L LBCL Patients initiated
“The ANTLER trial continues to push boundaries in evaluating the potential of allogeneic CAR-T therapies as we proceed with the dose expansion portion of ANTLER, which will now dose second-line patients with LBCL,” said Rachel Haurwitz, PhD, Caribou’s president and chief executive officer. “To our knowledge, CB-010 is the first allogeneic CAR-T cell therapy to […]
First Patient Dosed in the Ph 2 Study, Harmonic™, for LP-300 in Never Smokers with Advanced NSCLC
“Never-smokers with non-small cell lung cancer face limited choices in therapy options after treatment with targeted therapies, and we believe there is a great opportunity to introduce a therapeutic regimen designed specifically for this subgroup of cancer patients,” stated Reggie Ewesuedo, M.D., M.Sc., MBA, Lantern Pharma’s VP of Clinical Development. “These patients show tremendous bravery […]
First Patient Dosed in ONSEMBLE Ph 2 Randomized Trial of Onvansertib in Patients with mCRC
“We are excited to be underway with our ONSEMBLE trial that builds on the promising efficacy and tolerability results demonstrated in our phase 1b/2 trial in mCRC,” said Fairooz Kabbinavar, MD, Chief Medical Officer of Cardiff Oncology. “mCRC is a difficult-to-treat cancer and patients in the second line setting need novel therapeutic options to improve […]
First Patient Dosed in Ph 1/1b Dose Escalation/Dose Expansion Study of PRGN-3007 in Advanced ROR1+ Hematological and Solid Tumors
“We are excited to work with Precigen and announce that the first patient, a CLL patient, has been dosed in the first-in-human study of PRGN-3007 UltraCAR-T,” said Javier Pinilla-Ibarz, MD, PhD, Senior Member, Lymphoma Section Head and Director of Immunotherapy, Malignant Hematology Department, Moffitt, and Principal Investigator for the PRGN-3007 clinical study. “ROR1 is a […]
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 […]
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 […]
Botensilimab in Combination with Balstilimab Shows 33% Durable Responses in Ovarian Cancer
“These results add to the growing body of data showing deep and durable efficacy signals for botensilimab across nine cold and treatment-resistant cancers,” said Steven O’Day, M.D., Chief Medical Officer of Agenus. “Botensilimab is designed with a unique mechanism of action that stimulates both innate and adaptive immune responses against cancer, resulting in an improved […]
Neoadjuvant Opdivo + chemo Demonstrates Long-Term, Durable Clinical Benefits for Patients with Resectable NSCLC at Three Years in the CheckMate -816 Trial
“These updated results from CheckMate -816 are immensely important, as they show that the addition of nivolumab to chemotherapy provides sustained efficacy over three years when given before surgery and provide hope for the large portion of patients with non-small cell lung cancer facing high recurrence rates and for whom cure is not feasible with […]
Positive Topline Data from BDC-1001 Ph 1 Dose-Escalation Trial in HER2-Expressing Tumors announced, Supporting Advancement to Ph 2 Clinical Studies
“We are enthusiastic to be taking the next step in investigating the therapeutic promise of BDC-1001. In the study, we not only achieved target exposure levels for BDC-1001, but at those levels we saw promising signs of clinical activity as a single agent and in combination with nivolumab,” said Edith A. Perez, M.D., Chief Medical […]
New RYBREVANT (amivantamab-vmjw) Data Showed Long-Term Clinical Response and Safety in Patients with Advanced NSCLC with EGFR Exon 20 Insertion Mutations Who Have Failed Prior Platinum-Based Chemotherapy
“With these new data, amivantamab showed long-term consistent efficacy regardless of prior therapies or response to prior platinum chemotherapy,” said Pilar Garridot, M.D., Associate Professor of Medical Oncology at Universidad de Alcalá, Head of Medical Oncology Department at the University Hospital Ramón y Cajal in Madrid, Spain and principal investigator. “Due to the aggressive nature […]
Updated Efficacy and Safety of Taletrectinib in Patients with ROS1-Positive NSCLC announced
“We’re excited to see that, with longer follow-up time, taletrectinib continues to demonstrate robust efficacy outcomes and favorable safety profiles in patients with ROS1 TKI-naïve or crizotinib-pretreated ROS1+ NSCLC,” said Prof. Caicun Zhou, Shanghai Pulmonary Hospital and Thoracic Cancer Institute, Tongji University School of Medicine, Shanghai, China. “Additionally, taletrectinib hits a unique balance of strong […]
KEYTRUDA + Chemo Significantly Improved PFS vs chemo Alone as 1L Therapy for Advanced/Recurrent Endometrial Carcinoma, Regardless of Mismatch Repair Status
“Endometrial cancer is the most common type of gynecological cancer, and patients with advanced stage or recurrent disease face a poor prognosis with limited treatment options,” said Dr. Ramez Eskander, principal investigator and gynecologic oncologist, University of California San Diego, Moores Cancer Center. “The significant improvement in progression-free survival regardless of mismatch repair status observed […]
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 […]
Positive CHMP Opinion for CAR T Cell Therapy Breyanzi (lisocabtagene maraleucel) for R/R Large B-cell Lymphoma After One Prior Therapy
“This positive CHMP opinion is an important milestone towards introducing a potential new standard of care for people in the European Union living with relapsed or refractory large B-cell lymphoma after first-line treatment, an area of critical unmet need where few patients are able to undergo or derive long-term clinical benefit from stem cell transplant,” […]
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 […]
