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.
Frontline Durvalumab/Chemo Combo Improves OS in Extensive-Stage SCLC
June 27th 2019Durvalumab combined with standard etoposide and platinum-based chemotherapy demonstrated a statistically significant and clinically meaningful improvement in overall survival compared with standard chemotherapy alone as a first-line treatment in patients with extensive-stage small cell lung cancer, meeting the primary endpoint of the phase III CASPIAN trial (NCT03043872).
Borghaei Discusses Long-Term Pembrolizumab NSCLC Data, Broadening Clinical Trial Eligibility
June 26th 2019Hossein Borghaei, MD, highlights long-term single-agent pembrolizumab (Keytruda) data and the overall state of immunotherapy in non–small cell lung cancer, as well as the prospect of making clinical trial eligibility less restrictive.
Woyach Highlights Long-Term Acalabrutinib/Obinutuzumab Data in CLL
June 26th 2019Jennifer Woyach, MD, discusses the 3-year follow-up from the single-arm study of the combination of acalabrutinib (Calquence) and obinutuzumab (Gazyva) showcase the efficacy of the regimen in both patients with treatment-naïve and relapsed/refractory chronic lymphocytic leukemia and the future of treatment in the space.
FDA Approves Newly Designed Syringe for Lanreotide in GEP-NETs
June 25th 2019The FDA has granted an approval to a prefilled syringe for lanreotide (Somatuline Depot), which has been designed to enable healthcare providers to administer the injection easier, for the treatment of adults with unresectable, well or moderately differentiated, locally advanced or metastatic gastroenteropancreatic neuroendocrine tumors.
FDA Lifts Partial Clinical Hold on Venetoclax Myeloma Trial
June 25th 2019The FDA has lifted a partial clinical hold that was placed on the phase III CANOVA (M13-494; NCT03539744) trial, which is examining venetoclax in combination with pomalidomide and dexamethasone in patients with relapsed/refractory multiple myeloma that harbors t(11;14), according to AbbVie, the company that co-develops the BCL-2 inhibitor with Roche.
FDA Grants Priority Review to Niraparib for Late-Stage Ovarian Cancer
June 25th 2019The FDA has granted a priority review designation to a supplemental biologics license application for niraparib for the treatment of patients with advanced ovarian, fallopian tube, or primary peritoneal cancer who have been treated with ≥3 or more prior chemotherapy regimens, and who have either a BRCA mutation or have homologous recombination deficiency and progressed >6 months after their last platinum-based chemotherapy.
Frontline Nivolumab Misses OS Endpoint in Unresectable HCC
June 24th 2019Nivolumab (Opdivo) did not achieve statistical significance for improved overall survival compared with sorafenib (Nexavar) as a frontline therapy for patients with unresectable hepatocellular carcinoma as per a prespecified analysis, missing the primary endpoint of the phase III CheckMate-459 trial.
Atezolizumab/Cobimetinib Combo Misses PFS Endpoint in BRAF V600 Wild-Type Melanoma
June 21st 2019The combination of atezolizumab (Tecentriq) and cobimetinib (Cotellic) did not improve progression-free survival compared with pembrolizumab (Keytruda) in patients with previously untreated BRAF V600 wild-type melanoma, missing the primary endpoint of the phase III IMspire170 trial.
FDA Issues Complete Response Letter for Quizartinib in AML
June 21st 2019The FDA has issued a complete response letter to Daiichi Sankyo informing the company that its new drug application would not be approved for quizartinib for the treatment of adult patients with relapsed/refractory FLT3-ITD–positive acute myeloid leukemia.
O'Regan Assesses Treatment Courses and Durations in Early-Stage HR+ Breast Cancer
June 21st 2019Ruth O'Regan, MD, discusses current approaches to treatment escalation and de-escalation, as well as the use of retrospective molecular profiling, which may help address some unanswered questions in the field.