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.
CRESTONE Data Signal Positive Start to Treat Rare NRG1 Fusions in Solid Tumors
August 1st 2022Results of the phase 2 CRESTONE study have demonstrated the tolerable safety profile and efficacy of seribantumab for the treatment adult patients with metastatic solid or locally advanced tumors harboring the rare NRG1 fusions.
FDA Accepts BLA for N-803 in BCG-Unresponsive Non–Muscle Invasive Bladder Cancer in Situ
August 1st 2022The FDA has accepted for review a biologics license application for the IL-15 superagonist N-803 for the treatment of patients with Bacillus Calmette-Guérin–unresponsive non–muscle invasive bladder cancer carcinoma in situ.
Adjuvant Nivolumab/Ipilimumab Fails to Meet DFS End Point in Localized RCC
August 1st 2022The combination of nivolumab and ipilimumab failed to elicit a statistically significant improvement in disease-free survival compared with placebo as adjuvant treatment in patients with localized renal cell carcinoma who had undergone a full or partial removal of the kidney and were at moderate or high risk of relapse, failing to meet the primary end point of part A of the phase 3 CheckMate-914 trial.
Enhancing Awareness and Participation of Black Breast Cancer Patients in Clinical Trials
August 1st 2022Coral Omene, MD, PhD, medical oncologist in the Stacy Goldstein Breast Cancer Center at Rutgers Cancer Institute of New Jersey, the state’s only National Cancer Institute-designated Comprehensive Cancer Center together with RWJBarnabas Health, has been awarded a $50,000 grant from the V Foundation for Cancer Research in partnership with ESPN to increase clinical trial awareness and enrollment of Black women with breast cancer.
A Revolution Is Pending for Real-World Data Use in Cancer Care
August 1st 2022In the opinion of this commentator, one of the more exciting developments in clinical investigation over the past several years is the increasing recognition of the importance of real-world data and its role for physicians, regulators, policy makers, patients, and society.
Understanding the Role of pCR in Early-Stage TNBC Opens Doors for Tailored Treatment
July 30th 2022As ongoing research efforts are shifting further into personalized care, Hope S. Rugo, MD, FASCO discusses how pathologic complete response and the predictive value of residual cancer burden scoring are becoming a pivotal end point for the changing triple-negative breast cancer landscape.
How Low Can We Go? Metastatic Breast Cancer Enters a New Era of HER2 Classification
July 30th 2022Erika P. Hamilton, MD, shares how multidisciplinary collaboration between pathologist and breast oncologists is key to staying abreast of not only the classification-actionable HER2 mutations in metastatic breast cancer but also the evolving definition of expression.
Glutaminase Inhibition Represents Novel Treatment Strategy in NFE2L2- and KEAP1-Mutated NSCLC
July 30th 2022Jonathan Wesley Riess, MD, MS, discusses a phase 1 trial examining the combination of sapanisertib and telaglenastat, and explains why glutaminase inhibition is being investigated as a novel way to treat select patients with non–small cell lung cancer.
EGFR TKI–Based Combos Could Lead to More Tailored First-Line Treatment Options in EGFR-Mutated NSCLC
July 29th 2022Leveraging EGFR TKIs as a backbone for combination therapies will be pivotal for expanding treatment options and delivering more personalized therapies in the first-line setting for patients with non–small cell lung cancer harboring EGFR mutations.
Oral SERDs Could Fulfill Unmet Need in ESR1-Mutant, ER-Positive Breast Cancer
July 29th 2022Aditya Bardia, MD, MPH, discusses recent and ongoing trials evaluating oral SERDs in estrogen receptor–positive breast cancer, the effect of ESR1 mutations on treatment efficacy, and how the use of ctDNA continues to evolve across the breast cancer space.
HER2-Mutated NSCLC Treatment Evolves From Mainstay TKIs to Novel ADCs and Beyond
July 29th 2022Antibody-drug conjugates have demonstrated substantial activity in patients with HER2-mutated non–small cell lung cancer, with fam-trastuzumab deruxtecan-nxki showcasing the strongest response rate and progression-free survival benefit to date.
Value of Biomarkers for Immunotherapy in Advanced NSCLC Continue to Evolve
July 28th 2022Traditional predictive biomarkers for the efficacy of peri-operative immunotherapy for patients with advanced non–small cell lung cancer, such as PD-L1 expression, still hold value but newer biomarker candidates such as minimal residual disease are starting to make an impact.
Pre-NDA Meeting Held With FDA to Discuss Repotrectinib for ROS1+ Advanced NSCLC
July 28th 2022A pre–new drug application meeting was held with representatives from Turning Point Therapeutics, Inc. and the FDA to discuss repotrectinib as a potential therapeutic option for patients with ROS1-positive advanced non–small cell lung cancer.
PC14586 Shows Preliminary Activity, Safety in p53 Y220C–Mutant Solid Tumors
July 28th 2022The first-in-class p53 reactivator, PC14586, induced a response in approximately 1 of 4 patients with advanced solid tumors harboring p53 Y220C mutations and showcased an acceptable safety profile consisting primarily of grade 1 and 2 events.
Novel Agents Needed to Expand Treatment Options for Patients With High-Risk MDS
July 28th 2022Dan Pollyea, MD, MS, discussed the difficulties in developing new agents for the treatment of high-risk MDS, the objective of the ENHANCE trial, and the potential for other therapies to emerge in the treatment paradigm.