Noted

The FDA granted accelerated approval to enfortumab vedotin-ejfv (Padcev; Astellas/Seattle Genetics) for patients with locally advanced or metastatic urothelial cancer who have received prior PD-1–PD-L1 therapy and a platinum-containing chemotherapy. The decision was based on the phase II EV-201 trial, in which 44% of patients responded to the drug. Enfortumab vedotin-ejfv is the first Nectin-4–directed antibody–drug conjugate to be approved.

As part of a broader spending package, President Donald Trump signed legislation on December 20, 2019, prohibiting the sale of tobacco and electronic cigarettes to anyone under 21. The Tobacco 21 measure, which amends the Federal Food, Drug, and Cosmetic Act, immediately went into effect.

Merck announced that it will buy ArQule for $2.7 billion just as the Burlington, MA–based company presented positive results of a phase I trial of ARQ 531 in B-cell malignancies at the 2019 American Society of Hematology (ASH) Annual Meeting in Orlando, FL. An inhibitor of wild-type and C481S-mutant BTK, ARQ 531 elicited an overall response rate of 89% in patients with chronic lymphocytic leukemia and 50% of those with Richter transformation.

In a phase I/Ib trial, Genentech's mosunetuzumab induced complete remissions in patients with poor-prognosis non-Hodgkin lymphoma, including 22% of those whose had already received chimeric antigen receptor T-cell therapies, researchers reported at ASH. An off-the-shelf synthetic bispecific antibody, mosunetuzumab targets CD3 on T cells and CD20 on B cells.

Adding the small-molecule tyrosine kinase inhibitor tucatinib to trastuzumab (Herceptin; Genentech) and chemotherapy may improve survival in patients with locally advanced, inoperable, or metastatic HER2-positive breast cancer who have received prior therapies, according to findings presented at the 2019 San Antonio Breast Cancer Symposium in Texas (N Engl J Med 2019 Dec 11 [Epub ahead of print]). In the phase III HER2CLIMB trial, the tucatinib combination extended median overall survival by 4.5 months and median progression-free survival by 2.2 months compared with trastuzumab plus chemotherapy.

For more news on cancer research, visit Cancer Discovery online at http://cancerdiscovery.aacrjournals.org/CDNews.