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.
Enobosarm May Represent a Safe, New Hormone Treatment Approach for AR+, ER+ Metastatic Breast Cancer
July 6th 2021Hannah M. Linden, MD, discusses the potential for enobosarm in patients with metastatic breast cancer, data from a phase 2 trial examining its use, and next steps for the agent in the paradigm.
FDA Supports Continued Development of Oral Paclitaxel/Encequidar in Metastatic Breast Cancer
July 6th 2021Athenex, Inc. held a Type A meeting with the FDA to discuss the deficiencies raised in the complete response letter issued in March 2021 for the new drug application for oral paclitaxel plus encequidar in the treatment of patients with metastatic breast cancer.
Adjuvant Radiation Therapy Could Yield Reduction in All-Cause Mortality in High-Risk Prostate Cancer
July 6th 2021Men with positive pelvic lymph nodes or a prostatectomy Gleason score of 8 to 10 with disease extending beyond the prostate should be considered for treatment with adjuvant radiation therapy.
Merck Withdraws Pembrolizumab Third-Line Gastric Indication in the United States
July 6th 2021Merck has announced plans to withdraw the accelerated approval indication for pembrolizumab in the treatment of select patients with recurrent locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma whose tumors express a PD-L1 combined positive score of 1 or more, and who have progressed on or after 2 or more previous lines of therapy, including fluoropyrimidine- and platinum-containing chemotherapy, and HER2-/neu-targeted therapy, if appropriate.
GSK2636771/Paclitaxel Combo Demonstrates Early Promise in Advanced PTEN-Deficient Gastric Cancer
July 3rd 2021The novel PI3Kß inhibitor GSK2636771 plus paclitaxel led to encouraging clinical activity as well as a tolerable safety profile in patients with PTEN-deficient advanced gastric cancer who progressed following frontline chemotherapy.
Yale Cancer Center Laboratory Study Shows Combination Treatment Effective in IDH-Mutant Cancers
July 2nd 2021A new study led by Yale Cancer Center scientists revealed the combination of ATR and PARP inhibitor therapies can effectively target the enzyme isocitrate dehydrogenase-I/2 (IDH-1/2) in mutant cancer cells.
Phase 3 ARMADA 2000 Trial of Devimistat in Relapsed/Refractory AML to Continue
July 2nd 2021An independent data monitoring committee has recommended that the phase 3 ARMADA 200 trial examining devimistat plus high-dose cytarabine and mitoxantrone in patients with relapsed or refractory acute myeloid leukemia continue as planned.
Frontline Pemigatinib Under Investigation in Advanced FGFR2+ Cholangiocarcinoma
July 2nd 2021Single-agent pemigatinib is being compared with gemcitabine plus cisplatin in patients with unresectable and/or metastatic cholangiocarcinoma whose tumor harbor FGFR2 fusions or rearrangements in the ongoing, phase 3 FIGHT-302 trial.
Scientific Communication Requires a Course Correction
July 2nd 2021The overall picture related to COVID-19 in the Unites States is encouraging, and we might suspect that the American public would be relatively united with favorable views of efforts of public health officials and organizations at the national, state, and local levels to successfully control this terrible event and return us to our prepandemic state.
Lenvatinib Treatment Can Continue in Unresectable HCC With Child–Pugh Class-B Liver Function
July 1st 2021Lenvatinib can continue to be administered in patients with unresectable hepatocellular carcinoma that has Child-Pugh class B liver function, as they experienced a similar tumor size reduction as their Child-Pugh class A counterparts in a post-hoc analysis of the phase 3 REFLECT trial.
FDA Approves Dose-Escalation Label Update for Neratinib in HER2+ Breast Cancer
July 1st 2021The FDA has approved a labeling supplement to the US prescribing information for neratinib that includes the dose-escalated use of the agent in patients with HER2-positive breast cancer, as examined in the phase 2 CONTROL trial, and the new 133-count commercial Nerlynx SKU.
Pembrolizumab/Lenvatinib Regimen Being Tested in Advanced Gastroesophageal Adenocarcinoma
July 1st 2021Frontline pembrolizumab plus lenvatinib, and chemotherapy is being tested against chemotherapy alone in patients with advanced gastroesophageal adenocarcinoma, as part of the international, 2-part, phase 3 LEAP-015 trial.
Adjuvant Advances Shine at ASCO 2021
July 1st 2021Novel therapeutic strategies are poised to expand in adjuvant settings for patients with early-stage disease facing recurrence risks in the treatment paradigms for a range of tumor types after positive data from large phase 3 clinical trials were highlighted at the 2021 American Society of Clinical Oncology Annual Meeting