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.
Osimertinib/Bevacizumab Improves ORR, But Fails to Prolong PFS in EGFR T790M+ NSCLC
January 8th 2021January 8, 2021 — The combination of osimertinib plus bevacizumab failed to result in a statistically significant improvement in progression-free survival versus osimertinib alone in patients with advanced lung adenocarcinoma that harbored an EGFR T790M mutation.
Brexucabtagene Autoleucel Provides New Option for Patients With R/R MCL
January 8th 2021Brexucabtagene autoleucel induced durable response in patients with relapsed/refractory mantle cell lymphoma, according to findings from the phase 2 ZUMA-2 trial, leading to an FDA approval for use in this patient population on July 24, 2020.
FDA Updates Label for Darolutamide in Nonmetastatic CRPC to Include OS Data
January 8th 2021January 8, 2021 - The FDA has approved a supplemental new drug application to add overall survival and other secondary end point data from the phase 3 ARAMIS trial to the prescribing information for darolutamide for the treatment of patients with nonmetastatic prostate cancer.
NICE Rejects Nivolumab for Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma
January 8th 2021January 8th, 2021 - The United Kingdom’s National Institute for Health and Care Excellence has issued guidelines recommending against nivolumab for use in patients with recurrent or metastatic head and neck squamous cell carcinoma who experienced disease progression during or after platinum-based chemotherapy.
FDA Grants Fast Track Designation to Zenocutuzumab for Metastatic NRG1+ Solid Tumors
January 8th 2021January 8, 2021 — The FDA has granted a fast track designation to zenocutuzumab for the treatment of patients with metastatic solid tumors that harbor NRG1 gene fusions and have progressed on standard-of-care treatment.
Hussain and Taplin Talk Gender-Specific Struggles, Career Lessons in GU Oncology
January 8th 2021Maha H.A. Hussain, MD, and Mary-Ellen Taplin, MD, sit down with OncLive® to travel the road that led them to specialize in genitourinary oncology, the challenges they experienced as a female in the field, and advice they would give to not only other rising female oncologists, but to their younger selves knowing what they know now.
Need for Molecular Testing in Lung Cancer Is Underscored as Additional Targets Emerge
January 8th 2021Yujie Zhao, MD, PhD, highlights molecular testing and how it's a critical component of the treatment selection process in lung cancer, as a host of effective drugs have since been developed to target alterations such as ALK, ROS1, and RET.
Eganelisib/Nivolumab Elicits Promising Responses, PFS Benefit in Metastatic Urothelial Cancer
January 7th 2021January 7th, 2021 - The addition of eganelisib to nivolumab was found to elicit encouraging responses and improve progression-free survival compared with single-agent nivolumab in patients with platinum-refractory, immunotherapy-naïve, advanced, metastatic urothelial cancer.
Less Tumor Texture Variability From Baseline May Be Linked With Better Outcomes in PDAC
January 7th 2021January 7, 2021 - Patients with pancreatic ductal adenocarcinoma who were treated with a 920 mg dose of SM-88 were less likely to experience a change in tumor texture and were found to have more favorable outcomes, according to results from a phase 2 dose-escalation trial.
FDA Grants 3 Rare Pediatric Disease Designations to STAT3 Inhibitor WP1066
January 7th 2021January 7, 2020 - The FDA has approved the request submitted by Moleculin Biotech, Inc. for rare disease designations to be granted their drug candidate WP1066, an agent that appears to directly elicit tumor cell death and rouse the immune system to eliminate tumors.
Next-Generation Cytotoxic Therapy Moves Forward in mCRPC
January 7th 2021VERU-111, a next-generation form of chemotherapy, has shown promising signs of efficacy as a treatment option for men with metastatic castration-resistant prostate cancer whose disease has progressed while receiving androgen receptor–targeting therapy.
Chemoimmunotherapy Continues to Display Survival Benefits in Small Cell Lung Cancer
January 7th 2021Yanyan Lou, MD, PhD, highlighted the role of atezolizumab, durvalumab, pembrolizumab, and nivolumab and how they have demonstrated improved survival in combination with etoposide and platinum in untreated extensive-stage small cell lung cancer, cementing checkpoint inhibition plus chemotherapy as a frontline standard.
TP53, NF1 Among Genetic Variants Identified as Precursors to Pediatric Rhabdomyosarcoma
January 6th 2021Germline predisposition variants associated with cancer susceptibility syndromes can underlie the genetic risk for rhabdomyosarcoma, indicating that germline testing should be performed in accordance with RMS subtypes and irrespective of age.
Vemurafenib Plus Cetuximab/Irinotecan Improves PFS in BRAF-Mutant Metastatic CRC
January 6th 2021January 6th, 2021 - The addition of vemurafenib to irinotecan and cetuximab led to a significant improvement in progression-free survival versus irinotecan and cetuximab alone in patients with BRAF V600E–mutated metastatic colorectal cancer.
Updated ExteNET Data Raise Questions Over TKI Utility in HER2+ Breast Cancer With Brain Metastases
January 6th 2021Adam M. Brufsky, MD, PhD, discusses the updated findings from the ExteNET trial, the role of TKIs in treating patients with brain metastases, and unanswered questions that future research efforts should aim to address.
FDA Grants Fast Track Status to ADC ARX788 for HER2+ Metastatic Breast Cancer
January 5th 2021January 5th, 2021 -The FDA has granted a fast track designation to the investigational antibody-drug conjugate ARX788 for use as a monotherapy in the treatment of patients with advanced or metastatic HER2-positive breast cancer who have previously received 1 or more HER2-targeted regimens in the metastatic setting.
Japanese Approval Sought for Oncolytic Virus Teserpaturev for Malignant Glioma
January 5th 2021January 5, 2020 - A new drug application has been submitted to Japan’s Ministry of Health, Labour, and Welfare for the oncolytic virus teserpaturev for use in the treatment of patients with malignant glioma.
FDA Grants Breakthrough Therapy Designation to Tiragolumab Plus Atezolizumab for PD-L1–High NSCLC
January 5th 2021January 5th, 2021 - The FDA has granted a breakthrough therapy designation to the anti-TIGIT therapy tiragolumab for use in combination with atezolizumab in the frontline treatment of patients with metastatic non–small cell lung cancer whose tumors are PD-L1 high and do not harbor any EGFR or ALK aberrations.
Homing in on HER2-Targeted Treatment Strategies in Early and Advanced Breast Cancer
January 5th 2021Clinical risk continues to guide treatment decisions in early-stage HER2-positive breast cancer. The presence of brain metastases has become a driving force for treatment selection in the metastatic setting.
Ripretinib Under Investigation for Second-Line GIST in Phase 3 INTRIGUE Trial
January 5th 2021January 5th, 2021 - Ripretinib is under investigation as a second-line treatment in patients with gastrointestinal stromal tumor versus sunitinib in the phase 3 INTRIGUE trial, which recently completed its target enrollment.
Parsing Out Remaining Questions With CDK4/6 Inhibitors in HR+ Breast Cancer
January 5th 2021Sarah Sammons, MD, discusses the clinical significance of ESR1 mutations in HR-positive, HER2-negative breast cancer, how to determine the optimal timing to perform genetic sequencing for ESR1 mutations, and emerging agents, like lasofoxifene, that are poised to transform the paradigm for patients who harbor these mutations.