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.
TOCA 511 and Toca FC Treatment Misses OS Endpoint in Glioma Trial
September 13th 2019Treatment with Toca 511 and Toca FC did not improve overall survival compared with standard therapy in patients with recurrent high-grade glioma undergoing resection, missing the primary endpoint of the phase III Toca 5 trial.
Maintenance CC-486 Improves OS in Newly Diagnosed AML
September 13th 2019Maintenance therapy with CC-486 (oral azacitidine) led to a highly statistically significant and clinically meaningful improvement in overall survival compared with placebo in patients with newly diagnosed acute myeloid leukemia who achieved first complete response or CR with incomplete blood count recovery with induction therapy.
Liquid Biopsy Matches Tissue for NSCLC Treatment Guidance
September 12th 2019Patients with advanced non–small cell lung cancer and actionable mutations had similar progression-free survival whether treatment guidance came from tissue or circulating tumor (ct)DNA analysis using the Guardant360 assay, a matched retrospective comparison showed.
Atezolizumab Monotherapy Improves Survival in Frontline PD-L1-High NSCLC
September 12th 2019Single-agent atezolizumab extended overall survival compared with chemotherapy as a frontline treatment for patients with advanced nonsquamous and squamous non–small cell lung cancer and high PD-L1 expression, according to topline findings from the phase III IMpower110 trial.
FDA Accepts sNDA for Neratinib Combo for HER2+ Breast Cancer
September 11th 2019The FDA has accepted a supplemental new drug application for neratinib for use in combination with capecitabine for the treatment of patients with HER2-positive metastatic breast cancer who have failed at least 2 prior lines of HER2-directed treatments.
Updated OS Data Reported With Tivozanib in Highly Refractory Metastatic RCC
September 10th 2019Results from the second prespecified analysis of the TIVO-3 trial showed a hazard ratio for overall survival of 0.99 for tivozanib compared with sorafenib in patients with highly refractory metastatic renal cell carcinoma.
Frontline Atezolizumab Plus Carboplatin/Nab-Paclitaxel Approved in Europe for Nonsquamous NSCLC
September 6th 2019The European Commission has approved atezolizumab for use in combination with carboplatin and nab-paclitaxel for the first-line treatment of adult patients with advanced, nonsquamous non–small cell lung cancer.
Atezolizumab Combo Approved in Europe for Small Cell Lung Cancer
September 6th 2019The European Commission has approved atezolizumab for use in combination with carboplatin and etoposide for the frontline treatment of adult patients with extensive-stage small cell lung cancer, according to Roche (Genentech) the developer of the PD-L1 inhibitor.
Nivolumab Combo Misses PFS Endpoint in Newly Diagnosed MGMT-Methylated GBM
September 5th 2019The combination of nivolumab plus standard temozolomide and radiation therapy did not show a statistically significant improvement in progression-free survival compared with temozolomide/radiation therapy alone in patients with newly diagnosed glioblastoma multiforme that is O6-methylguanine-DNA methyltransferase-methylated, missing one of the primary endpoints of the phase III CheckMate-548 trial.
USPSTF Releases Final Recommendation on Treatments for Reducing Breast Cancer Risk
September 5th 2019Risk-reducing therapies, such as tamoxifen, raloxifene, or aromatase inhibitors, should be administered to women who are at an increased risk for breast cancer and at a low risk for adverse events associated with these medications.
FDA Grants Nirogacestat Breakthrough Designation for Desmoid Tumors
September 4th 2019The FDA has granted a breakthrough therapy designation to the investigational gamma-secretase inhibitor nirogacestat (PF-03084014) for the treatment of adult patients with progressive, unresectable, recurrent or refractory desmoid tumors or deep fibromatosis.