A collection of recently published news items.
Bristol Myers Squibb announced that the FDA approved the PD-1 inhibitor nivolumab (Opdivo) for patients with esophageal or gastroesophageal junction cancer who have residual pathologic disease after surgery and neoadjuvant chemoradiotherapy. The approval was based on the phase III CheckMate-577 trial in which nivolumab extended the median disease-free survival by 11.4 months compared with a placebo.
The U.S. Supreme Court declined to review a federal appeals court decision to include two U.S. scientists on immunotherapy patents describing the PD-1 pathway. The scientists—Gordon Freeman, PhD, of Dana-Farber Cancer Institute in Boston, MA, and Clive Wood, PhD, of Boehringer Ingelheim—will be added to the patents, which were initially issued to Ono Pharmaceutical and Tasuku Honjo, MD, PhD, of Kyoto University in Japan.
The TROP2-directed antibody–drug conjugate datopotamab deruxtecan (DS-1062; AstraZeneca/Daiichi Sankyo) may be active in patients with metastatic triple-negative breast cancer (TNBC) who have received other therapies. In a phase I trial, five of 21 evaluable patients responded to the drug, and four more responses await confirmation; 11 patients experienced stable disease. Findings were presented at the 2021 European Society of Medical Oncology Breast Cancer Virtual Congress.
Genentech's BRAF inhibitor vemurafenib (Zelboraf) and anti-CD20 agent rituximab (Rituxan) may lead to durable responses in hairy-cell leukemia (N Engl J Med 2021;384:1810–23). In a phase II trial, the drug elicited complete responses in 26 of 30 patients with relapsed/refractory disease, and 85% of patients who responded were relapse-free at a median follow up of 34 months.
African American women with TNBC may have a higher mortality rate than their white counterparts (JAMA Oncol 2021 May 13 [Epub ahead of print]). Researchers conducted a retrospective analysis of 23,123 women diagnosed with nonmetastatic TNBC between 2010 and 2015, 25.3% of whom were African American. They found that African American women had a 28% increased risk of death compared with white women, in part due to lower rates of surgery and chemotherapy.
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