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 […]
Prelude Therapeutics Announces Clinical Trial Collaboration with BeiGene to Evaluate PRT2527 in Combination with Zanubrutinib in Hematologic Cancers
“The opportunity to combine Prelude’s potent, selective and potentially best-in-class CDK9 inhibitor with BeiGene’s next-generation highly efficacious and tolerable BTK inhibitor, zanubrutinib, reflects our commitment to bringing the most promising options to patients,” said Jane Huang, MD, President and Chief Medical Officer, Prelude Therapeutics.
Leap Therapeutics Provides Update on BeiGene Option Agreement for DKN-01; DisTinGuish Trial of DKN-01 + tislelizumab & chemo to continue as a clinical collaboration
“We look forward to continuing to collaborate with BeiGene to execute on our first randomized controlled trial for DKN-01 in first-line gastric cancer patients,” said Douglas E. Onsi, President and Chief Executive Officer of Leap. “With global rights to DKN-01 and a cash runway that was enhanced into mid-2025 by our recent acquisition of Flame […]
Merck Strengthens Oncology Franchise by Securing Exclusive Worldwide Rights to Anti PD-L1 Antibody BAVENCIO® (avelumab)
“On behalf of Merck KGaA, Darmstadt, Germany, I’d like to thank Pfizer for their partnership and collaboration over the last nine years, and for the role they have played in the success of BAVENCIO,” said Belén Garijo, Chair of the Executive Board and CEO of Merck KGaA, Darmstadt, Germany. “Our joint efforts have delivered meaningful […]
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 […]
Ph 1/2 clinical trials of GoCAR-T cell product candidates in combination with rimiducid in heavily pre-treated cancer patients discontinued
“Bellicum Pharmaceuticals, Inc. (Nasdaq: BLCM), today announced its decision to discontinue its ongoing Phase 1/2 clinical trials evaluating the safety and preliminary efficacy of its GoCAR-T cell product candidates in combination with rimiducid in heavily pre-treated cancer patients. The trials for BPX-601 and BPX-603 are being discontinued following the Company’s assessment of the risk/benefit profile […]
First Patient dosed in FRIDA, a Ph Ib trial with iadademstat in R/R FLT3-mutant AML patients
Dr. Carlos Buesa, President and CEO of Oryzon, said: “FRIDA’s initiation is a significant corporate milestone for Oryzon, marking a further expansion of our clinical pipeline as we seek to improve the treatment options for patients. Iadademstat has already shown strong efficacy data in AML. We hope this combination will open up new ways to […]
Clinical Hold Announced on XMT-2056 Ph 1 Clinical Trial
“In line with our steadfast commitment to patient safety, we have been proactive in our response to this event. With the clinical hold in place, our efforts for XMT-2056 are now focused on undertaking the work required to fully analyze this SAE and consider potential next steps for development,” said Anna Protopapas, President and Chief […]
Ph 2/3 Trial for Eftilagimod Alpha plus Paclitaxel initiated in Metastatic Breast Cancer
Immutep CEO, Marc Voigt, said: “With its novel mechanism of action to activate antigen-presenting cells, efti has to date safely improved clinical outcomes from anti-PD-(L)1 therapies and standard-of-care chemotherapy. We look forward to AIPAC-003 building upon the encouraging synergy seen in our previous Phase IIb trial in metastatic breast cancer, especially with its three key […]
First Lung Cancer Patient Dosed in Ph 1 Trial for BBP-398 in Combination with OPDIVO® (nivolumab)
“SHP2 has been shown to be a key regulator of both tumor and immune cell signaling. In KRAS mutant tumors, SHP2 promotes survival, proliferation and decreased immunogenicity by driving the active form of KRAS, while in immune cells, it associates with PD-1 which leads to immunosuppression in the tumor microenvironment,” said Eli Wallace, Ph.D., chief […]
First Patient Dosed in the 300 mg Dose Group with Next Generation Chemotherapy-Capecitabine
“We are pleased to have now dosed the first patient in our 300 mg dose group. This dose group will provide more information on the drug exposure vs adverse event relationship which is critical to FDA approval given FDA’s Project Optimus Oncology initiative. In addition, the data obtained from this dose group will help us […]
First Patient Dosed in Phase 2b Trial of IGV-001 for Glioblastoma
“Progression into this Phase 2b clinical study is a significant milestone for both Imvax and the many patients and families facing a life-altering GBM diagnosis,” said John P. Furey, Chief Executive Officer of Imvax. “For too long, there have been few advancements in the treatment of GBM; with the initiation of this trial, we take […]
New Study Arm to Evaluate (Z)-Endoxifen added to the Ongoing I-SPY 2 Clinical Trial
“Atossa is proud to partner with Quantum Leap Healthcare Collaborative and excited that (Z)-endoxifen has been added to their unprecedented I-SPY clinical trial, which is designed to quickly and efficiently bring new drug therapies to breast cancer patients who need them urgently,” said Dr. Steven Quay, Atossa’s President and Chief Executive Officer. “Data from this […]
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 […]
Pivotal Ph 3 INDIGO Trial of vorasidenib in IDH-Mutant Low-Grade Glioma Meets Primary Endpoint of PFS and Key Secondary Endpoint of Time to Next Intervention (TTNI)
“Therapeutic progress in the low-grade glioma space has been stagnant for decades. The results of the Phase 3 INDIGO trial, meeting both the primary endpoint of progression-free survival and the key secondary endpoint of time to next intervention, presents an opportunity to shift the treatment paradigm for patients with IDH mutant low-grade glioma by potentially […]
Dose Escalation Portion of Phase 1 Solid Tumors Trial of TRE-515 Produces Favorable Results in Heavily Pretreated Solid Tumor Patients
“Based on the first-in-class mechanism of action, we believe TRE-515 has breakthrough potential. We’ve seen strong trial enrollment and remain optimistic for how TRE-515 can impact the future of cancer care,” said Dr. Zev Wainberg, principal investigator of the trial and medical oncologist at the University of California Los Angeles (UCLA). “We are especially excited […]
Ph 3 Study Shows XTANDI® (enzalutamide) plus Leuprolide Significantly Improves Metastasis-Free Survival in Men with Non-Metastatic Prostate Cancer
“As the only novel hormone therapy approved for three disease states of prostate cancer in the U.S., XTANDI has impacted hundreds of thousands of men,” said Chris Boshoff, M.D., Ph.D., Chief Development Officer, Oncology and Rare Disease, Pfizer Global Product Development. “The topline findings from EMBARK are highly encouraging and we look forward to engaging […]
A First Complete Bone Marrow Response in a R/R AML Patient From The Very Low Dose Arm of Its AB8939 Ph 1/2 Clinical Trial (AB18001) reported
Dr Pau Montesinos, hematologist at the La Fe University Hospital and coordinator of the Spanish group of acute myeloblastic leukemia (PETHEMA), said “It is remarkable that we rapidly observed a response in what is typically a difficult-to-treat patient population of refractory AML. We observe a clear blast count reduction for this patient and excellent tolerance […]
Ph 3 China ARCHES Study of XTANDI® Meets Primary Endpoint
“While past global studies have supported the use of XTANDI plus ADT in men with mHSPC, it is encouraging to see these results replicated for patients in mainland China,” said Prof. Zhou Fangjian, Head of Urology Department, Sun Yat-sen University Cancer Center, Sun Yat-sen University.
KEYTRUDA + Chemo Significantly Improved PFS vs chemo Alone as 1L Therapy for Advanced or Recurrent Endometrial Carcinoma, Regardless of MMR 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 […]
Kisqali® Ph 3 NATALEE Trial Meets Primary Endpoint At Interim Analysis Demonstrating Clinically Meaningful Benefit In Patients With Early Breast Cancer
“While most patients are diagnosed and treated early with the aim to cure breast cancer, the risk of cancer returning, often as metastatic disease, peaks within three years after diagnosis, but never goes away completely,” said Dennis J. Slamon, MD, Director of Clinical/Translational Research, University of California, Los Angeles Jonsson Comprehensive Cancer Center and Chairman […]
Zolbetuximab Improves Survival in Gastric Cancer
“The progression-free and overall survival data from GLOW demonstrate the potential of zolbetuximab in patients with CLDN18.2-positive, HER2-negative, locally advanced unresectable or metastatic gastric and gastroesophageal junction cancer,” said Rui-Hua Xu, M.D., Ph.D., Professor in the Department of Medical Oncology, Sun Yat-Sen University Cancer Center, Guangzhou, China, and the primary investigator of GLOW. “While the […]
Patritumab Deruxtecan Continues to Show Encouraging Clinical Activity in Distinct Patient Populations with Metastatic Lung and Breast Cancer in Updated Results of Two Early Trials
“Most patients with lung or breast cancer involved in these two early-stage trials were heavily pre-treated, underscoring the need for new and innovative treatment options to help improve outcomes,” said Mark Rutstein, MD, Global Head, Oncology Clinical Development, Daiichi Sankyo. “These results further add to the growing body of evidence that targeting HER3 with patritumab […]
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 […]
Yescarta® CAR T-cell Therapy Demonstrates a Statistically Significant Improvement in OS for Initial Treatment of R/R Large B-cell Lymphoma
Yescarta demonstrated a 2.5-fold increase in patients who were alive at two years and did not experience cancer progression or require the need for additional cancer treatment (40.5% vs. 16.3%) and a four-fold greater median EFS (8.3 mo. vs. 2.0 mo.) compared to SOC (hazard ratio 0.398; 95% CI: 0.308-0.514, P<0.0001). In addition to being […]
