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.
Neoadjuvant Daromun Elicits RFS Benefit in Locally Advanced, Fully Resectable Melanoma
October 16th 2023Neoadjuvant treatment with intratumoral daromun led to a statistically significant and clinically meaningful improvement in recurrence-free survival compared with surgery alone in patients with locally advanced, fully resectable melanoma, meeting the primary end point of the phase 3 PIVOTAL trial.
Dendritic Cell Vaccination Fails to Improve OS, Still Bolsters Immune Activation in Mesothelioma
October 16th 2023Joachim G. J. V. Aerts, MD, PhD, discusses how dendritic cell vaccines could bolster historically poor responses to immunotherapy in patients with mesothelioma, reports and provides potential explanations for negative results from the DENIM trial, and details a potential role for this therapy in earlier lines of mesothelioma treatment.
CHMP Recommends Dostarlimab Plus Chemotherapy in dMMR/MSI-H Advanced/Recurrent Endometrial Cancer
October 16th 2023The Committee for Medicinal Products for Human Use of the European Medicines Agency has recommended the approval of dostarlimab plus chemotherapy for the treatment of adult patients with mismatch repair–deficient/microsatellite instability–high primary advanced or recurrent endometrial cancer.
Two FCS Manuscripts Published in NEJM Within Two Months Co-Authored by Manish R. Patel, MD
October 16th 2023Florida Cancer Specialists & Research Institute, LLC Director of Drug Development Manish Patel, MD is the co-author for two manuscripts published in the New England Journal of Medicine within two months.
European Commission Approves Adjuvant Pembrolizumab for High-Risk NSCLC
October 16th 2023The European Commission has approved pembrolizumab as adjuvant monotherapy for the treatment of adult patients with non–small cell lung cancer who are at high risk of recurrence following complete resection and platinum-based chemotherapy.
New Data Bring Excitement, Raise Questions in Advanced RCC
October 16th 2023Although renal cell carcinoma remains a difficult-to-treat disease, with patients with clear cell histology experiencing a median overall survival of approximately 13 months and a 5-year overall survival rate of less than 10%, updated results from clinical trials examining emerging therapeutic strategies have spurred optimism.
Emerging Therapies Underscore Need for Genomic Testing in HR+/HER2– Breast Cancer
October 16th 2023Kari Wisinski, MD, highlights the use of oral selective estrogen receptor degraders and CDK4/6 inhibitors in the treatment of patients with hormone receptor–positive/HER2-negative breast cancer, the growing role of antibody-drug conjugates across the breast cancer spectrum, and ongoing research taking place at Carbone Cancer Center.
Infection Risk Increases With Longer Surgical Duration in Lower Extremity Bone Tumors
October 15th 2023R. Lor Randall, MD discusses the primary results of the PARITY study and their implications for the use of antibiotics for patients with lower extremity bone tumors undergoing surgery and highlighted the findings from the secondary analysis of the study on the effect of surgical duration on risk of infection
Zanubrutinib Plus Obinutuzumab Approaches EU Approval in R/R Follicular Lymphoma
October 13th 2023The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended the approval of zanubrutinib in combination with obinutuzumab for use in adult patients with relapsed or refractory follicular lymphoma who have previously received at least 2 lines of systemic treatment.
FDA Approves Companion Diagnostics for Encorafenib/Binimetinib in BRAF V600E+ Metastatic NSCLC
October 13th 2023The FDA has approved FoundationOne® CDx and FoundationOne Liquid CDx for use as companion diagnostics to identify patients with metastatic non–small cell lung cancer harboring BRAF V600E mutations who may benefit from treatment with the combination of encorafenib plus binimetinib.
Pirtobrutinib to be Compared with Ibrutinib in CLL/SLL Ongoing BRUIN CLL-314 Trial
October 13th 2023The phase 3 BRUIN CLL-314 trial evaluating the selective noncovalent BTK inhibitor pirtobrutinib vs the potent covalent BTK inhibitor ibrutinib is currently enrolling patients with chronic lymphocytic leukemia and small lymphocytic lymphoma who previously received treatment with non-BTK inhibitor therapy.
First-Line UV1 Vaccine Plus Pembrolizumab Sustains OS in Unresectable or Metastatic Melanoma
October 12th 2023First-line treatment with the universal cancer vaccine UV1 in combination with pembrolizumab sustained overall survival in patients with advanced unresectable or metastatic malignant melanoma, according to updated data from cohort 1 of the phase 1 UV1-103 trial.