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.
Nivolumab Plus Low-Dose Ipilimumab Shows Durable Responses for PD-L1-Negative, TMB-High NSCLC
June 6th 2018The combination of nivolumab and low-dose ipilimumab reduced the risk of progression or death by 52% compared with standard platinum doublet chemotherapy for patients with metastatic PD-L1–negative, tumor mutation burden-high non–small cell lung cancer.
Dacomitinib Demonstrates Superior OS Versus Gefitinib in EGFR-Mutant NSCLC
June 6th 2018The investigational second-generation tyrosine kinase inhibitor dacomitinib improved overall survival compared with gefitinib as first-line treatment in patients with advanced non-small cell lung cancer harboring activating EGFR mutations.
Trastuzumab Biosimilar Demonstrates Equivalence to Reference Product in HER2-Positive Breast Cancer
June 6th 2018The pathologic complete response rate associated with the trastuzumab biosimilar ABP 980 was equivalent to that of reference trastuzumab based on central laboratory evaluation in patients with HER2-positive early breast cancer enrolled in the phase III LILAC study.
48 Week PFS Similar for MYL-1401O, Trastuzumab in HER2-Positive Metastatic Breast Cancer
June 5th 2018MYL-1401O (Ogivri; trastuzumab-dkst) added to a taxane as initial therapy followed by MYL-1401O monotherapy as maintenance resulted in a nearly identical rate of progression-free survival compared with trastuzumab (Herceptin) in patients with HER2-positive metastatic breast cancer.
Bevacizumab Biosimilar Demonstrates Similar Response Rate, Survival as European Originator
June 5th 2018The bevacizumab biosimilar PF-06439535 demonstrated similarity to the European Union bevacizumab reference product for overall response rate, with similar pharmacokinetic and immunogenicity profiles for patients with advanced non-squamous non-small cell lung cancer.
FDA Grants Frontline Eltrombopag Priority Review for Severe Aplastic Anemia
May 31st 2018The FDA has granted a priority review to a supplemental new drug application for eltrombopag (Promacta) for use in combination with standard immunosuppressive therapy as a frontline treatment for patients with severe aplastic anemia.
FDA Grants Crizotinib Breakthrough Designation for MET+ NSCLC and ALK+ ALCL
May 30th 2018The FDA has granted crizotinib a breakthrough therapy designation for the treatment of patients with metastatic non–small cell lung cancer with MET exon 14 alterations, and for use in patients with relapsed/refractory ALK+ anaplastic large cell lymphoma.
Studies Stopped for Daratumumab/Checkpoint Inhibitor Combos in NSCLC, Myeloma
May 29th 2018Two separate early-phase clinical trials exploring daratumumab in combination with either a PD-1 inhibitor for multiple myeloma or a PD-L1 inhibitor for non–small cell lung cancer were terminated following a planned interim analysis.
Durvalumab Improves Survival in Stage III NSCLC
May 25th 2018Durvalumab significantly improved overall survival versus placebo when used as a sequential treatment in patients with locally-advanced, unresectable non–small cell lung cancer who had not progressed following standard chemoradiotherapy, according to updated findings from the phase III PACIFIC trial.