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.
Phase 2 Trial Expanded to Examine AGEN1181 Plus Balstilimab in Colon Cancer
December 3rd 2020December 3, 2020 - A phase 2 trial has expanded to examine the use of the CTLA-4 antibody AGEN1181 in combination with the novel anti–PD-1 human monoclonal antibody balstilimab in patients with colon cancer.
Survivin-Targeted T-Cell Therapy Shows Durable Activity in Advanced Recurrent Ovarian Cancer
December 3rd 2020December 3, 2020 — The survivin-targeted T-cell therapy DPX-Survivac, when used in combination with intermittent low-dose cyclophosphamide, prolonged clinical benefit with promising tolerability in patients with recurrent, advanced platinum-sensitive and -resistant ovarian cancer.
Lurbinectedin/Doxorubicin Combo Misses OS End Point in Phase 3 SCLC Trial
December 3rd 2020December 3, 2020 - Lurbinectedin plus doxorubicin failed to significantly improve overall survival versus physician’s choice of topotecan or cyclophosphamide/doxorubicin/vincristine in patients with small cell lung cancer who progressed after 1 previous platinum-containing line of treatment, missing the primary end point of the phase 3 ATLANTIS trial.
COVID-19 Sharpens Focus on Drug Holidays
December 3rd 2020Having patients go on drug holidays or intermittent therapy is a common strategy during treatment of prostate cancer and several other malignancies, whether to provide temporary relief from adverse effects influencing quality of life, to prevent long-term health impacts, or to lessen drug resistance that would render the therapy ineffective.
FDA Approval Sought for Amivantamab for Metastatic EGFR Exon 20–Positive NSCLC
December 3rd 2020December 3, 2020 — A biologics license application has been submitted to the FDA for the EGFR-MET bispecific antibody amivantamab for the treatment of patients with metastatic non–small cell lung cancer with EGFR exon 20 insertion mutations who have progressed on or following a platinum-based chemotherapy.
Overcoming Mechanisms of Resistance to CDK4/6, PI3K Inhibition in Breast Cancer
December 3rd 2020Cynthia X. Ma, MD, PhD, discusses several research efforts examining mechanisms of resistance to CDK4/6 and PI3K inhibitors in breast cancer and some of the novel combinations that may possess the potential to overcome this challenge.
Nadofaragene Firadenovec Continues to Show Strong Activity in BCG-Unresponsive High-Grade NMIBC
December 2nd 2020December 2, 2020 - Patients with high-grade Bacillus Calmette-Guérin unresponsive non-muscle invasive bladder cancer who responded to the investigational gene therapy nadofaragene firadenovec had a lower rate of cystectomy and delayed time to cystectomy compared with those who did not respond.
Pivotal Trials Lead to Transformative Approaches in HER2+ Breast Cancer
December 2nd 2020December 2, 2020 - Four pivotal trials––KATHERINE, FeDeriCa, DESTINY-Breast01, and HER2CLIMB have not only amplified the armamentarium in HER2-positive breast cancer, but have illustrated the importance of neoadjuvant therapy, alternative administration methods, high-potency HER2-targeted therapy, and inclusion of all-comers with brain metastases in clinical trials.
FDA Approves Pralsetinib for RET+ Thyroid Cancers
December 1st 2020December 1, 2020 - The FDA has approved pralsetinib for the treatment of select patients with advanced or metastatic RET-mutant medullary thyroid cancer who require systemic therapy or RET fusion-positive thyroid cancer who require systemic therapy and who are radioactive iodine-refractory.
FDA Grants Fast Track Status to Irinotecan Liposome Injection for Second-Line SCLC
December 1st 2020December 1, 2020 — The FDA has granted a fast track designation to irinotecan liposome injection as second-line monotherapy option for patients with small cell lung cancer whose disease progressed following a platinum-based chemotherapy regimen.
FDA Approval Sought for Ublituximab/Umbralisib Combo in CLL
December 1st 2020December 1, 2020 - A rolling submission of a biologics license application to the FDA has been initiated for the CD20-directed monoclonal antibody ublituximab in combination with the PI3K-delta and CK1-epsilon inhibitor umbralisib for the treatment of patients with chronic lymphocytic leukemia.
Pandemic Heightens Stress of Cancer Diagnosis
December 1st 2020The repercussions of delays in diagnosing cancer, either through screening or the presence of early symptoms, and of required modifications in standard-of-care management paradigms in the COVID-19 era are only now beginning to be fully appreciated.
Response-Based Radiation Is Effective, Safe in Pediatric High-Risk Hodgkin Lymphoma
December 1st 2020The use of response-based consolidation coupled with radiation therapy was found to be effective and well tolerated, with low failure rates, in pediatric patients with high-risk classical Hodgkin lymphoma.