The OncLive® News page includes the latest in clinical oncology news, including breaking regulatory decisions, clinical trial findings, pivotal and practice-changing data published in academic peer-reviewed journals, and more across solid and hematologic malignancies. Regulatory news includes new drug approvals by the FDA and European Union, priority review and breakthrough therapy designations, and orphan drug and fast track statuses.
Nivolumab Plus FOLFOXIRI/Bevacizumab Elicits Promising Responses in RAS/BRAF-Mutated mCRC
July 7th 2022The addition of nivolumab to FOLFOXIRI and bevacizumab resulted in encouraging responses when used as frontline treatment in patients with advanced or metastatic colorectal cancer harboring RAS or BRAF mutations, irrespective of microsatellite status.
FDA Grants Fast Track Designation to Belzupacap Sarotalocan for Non–Muscle Invasive Bladder Cancer
July 7th 2022The FDA has granted a fast track designation to belzupacap sarotalocan for the treatment of patients with non–muscle invasive bladder cancer, representing the first virus-like drug conjugate candidate therapy from Aura Biosciences, Inc., the drug developer.
AL102 Monotherapy Demonstrates Early Antitumor Activity in Desmoid Tumors
July 6th 2022Interim findings from part A of the phase 2/3 RINGSIDE trial indicated that the selective oral gamma-secretase inhibitor, AL102, was found to have favorable tolerability and early antitumor activity in patients with desmoid tumors.
FDA Accepts BLA Resubmission for Toripalimab in Advanced Nasopharyngeal Carcinoma
July 6th 2022The FDA has accepted for review a biologics license application resubmission for toripalimab both in combination and as monotherapy for patients with advanced recurrent or metastatic nasopharyngeal carcinoma, according to an announcement from drug developer Coherus.
New Findings in Breast Cancer Trials Call for Restructuring of Disease Subtypes
July 6th 2022Gregory Vidal, MD, PhD, including the evolution of treatment options for HER2-low breast cancer, emerging antibody-drug conjugates in triple-negative disease, and the viability of HER3 as an emerging target in breast cancer
FDA Grants Priority Review to Mosunetuzumab for Relapsed/Refractory Follicular Lymphoma
July 6th 2022The FDA has accepted a biologics license application and granted a priority review designation to mosunetuzumab, a potential first-in-class CD20 and CD3 T-cell engaging bispecific antibody, for the treatment of patients with relapsed/refractory follicular lymphoma following at least 2 prior systemic therapies.
Tisa-cel Adds a Potential New ‘Standard-of-Care’ in Third-Line Treatment of Follicular Lymphoma
July 6th 2022Stephen J. Schuster, MD, discusses the implications of the FDA approval of tisagenlecleucel on the treatment strategy for relapsed/refractory follicular lymphoma and the next steps for tisa-cel.
Brexucabtagene Autoleucel Has Durable Efficacy in B-ALL, Irrespective of Age and Tumor Burden
July 4th 2022Bijal Shah, MD, MS, discusses the long-term data from the ZUMA-3 trial of brexucabtagene autoleucel in patients with relapsed/refractory B-cell acute lymphoblastic leukemia and spotlighted additional areas ripe for further exploration.
Tucatinib Plus Trastuzumab Induces Durable Tumor Response in HER2+ mCRC
July 2nd 2022Patients with previously treated metastatic HER2-positive colorectal cancer experienced clinically meaningful and durable responses to treatment with tucatinib plus trastuzumab, according to data from the phase 2 MOUNTAINEER trial.
ALRN-6924 Halts Development in P53-Mutant NSCLC, Advances in P53-Mutant Breast Cancer
July 1st 2022Drug manufacturer Aileron plans to stop further enrollment into a phase 1b trial (NCT04022876) after the chemoprotective agent ALRN-6924 missed its composite primary end point for patients with advanced p53-mutant non–small cell lung cancer.
KRYSTAL-12 Investigators Seek to Confirm Adagrasib’s Role in KRAS G12C–Mutant NSCLC
July 1st 2022Efforts to unlock treatment modalities targeting KRAS mutations have ebbed and flowed for patients with non–small cell lung as investigators face resistance, intolerable toxicity profiles, and a lack of available binding pockets to guide treatment development.
FDA Issues Warning for Increased Risk of Death, Serious AEs with Duvelisib in CLL/SLL
July 1st 2022The FDA has warned that treatment with duvelisib has shown a possible increased risk of death and serious adverse effects compared with ofatumumab in patients with relapsed/refractory chronic lymphocytic leukemia and small lymphocytic lymphoma.
FDA Approval Sought for Subcutaneous Epcoritamab for Relapsed/Refractory LBCL
July 1st 2022Genmab A/S shared plans to submit a biologics license application to the FDA seeking the approval of subcutaneous epcoritamab for the treatment of patients with relapsed or refractory large B-cell lymphoma in the second half of 2022.
Tremelimumab/Durvalumab Produces Favorable OS Benefit in Unresectable HCC Irrespective of ALBI Grade
June 30th 2022A single priming dose of tremelimumab added to regular interval durvalumab generated significantly improved overall survival compared with sorafenib in the frontline setting for patients with unresectable hepatocellular carcinoma, irrespective of of their baseline albumin-bilirubin grade, according to updated data from the phase 3 HIMALAYA trial.
Tislelizumab Plus Chemotherapy Elicits Strong Survival Benefit in Esophageal Cancer
June 30th 2022The combination of tislelizumab and chemotherapy demonstrated a superior overall survival benefit compared with chemotherapy alone in patients with metastatic or unresectable esophageal squamous cell carcinoma