Noted

The FDA approved the tyrosine kinase inhibitor tucatinib (Tukysa; Seattle Genetics) plus trastuzumab (Herceptin; Genentech) and capecitabine for certain patients with locally advanced inoperable or metastatic HER2-positive breast cancer. The approval was based on a phase II trial in which the agent extended median progression-free survival and overall survival by 2.2 months and 4.5 months, respectively, compared with trastuzumab and capecitabine alone.

The agency also approved the antibody–drug conjugate sacituzumab govitecan-hziy (Trodelvy; Immunomedics) for patients with metastatic triple-negative breast cancer who have received prior therapies. The approval was based on a phase II trial in which the drug elicited an overall response rate of 33.3% and a median duration of response of 7.7 months.

Janssen Biotech will pay Fate Therapeutics $50 million up front and $50 million in equity in a deal that could be worth up to $3 billion in milestone payments. The companies will develop novel chimeric antigen receptor (CAR) natural killer cell and CAR T-cell candidates by combining Fate's induced pluripotent stem cell platform with Janssen's tumor-targeting antigen binders.

A survey of 32 cancer centers revealed how the COVID-19 pandemic is disrupting clinical trials. Overall, 54.8% of centers reported that patients are less willing to visit trial sites; 45.2% reported a reduction in staff to handle trials; and 38.7% reported issues with protocol compliance, or delays in scheduling and providing routine services.

Kite's experimental anti-CD19 chimeric antigen receptor T-cell therapy KTE- X19 may be effective in patients with relapsed/refractory mantle-cell lymphoma who have previously received a Bruton tyrosine kinase inhibitor (N Engl J Med 2020;382:1331–42). In a phase II trial, the therapy elicited a response in 93% of 60 patients, and 57% of patients were in remission at a median follow-up of 12.3 months.

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