AstraZeneca will pay Daiichi Sankyo $1 billion up front and up to $5 billion more in milestone payments in a deal that focuses on Daiichi Sankyo’s investigational agent DS-1062. The companies will jointly develop and commercialize DS-1062, a TROP2-directed antibody–drug conjugate (ADC) being tested in non–small cell lung cancer (NSCLC) and triple-negative breast cancer. The companies made a similar deal in March 2019 centered on Daiichi Sankyo’s HER2-targeted ADC, trastuzumab deruxtecan (Enhertu).
The FDA approved brexucabtagene autoleucel (Tecartus; Gilead) for patients with relapsed/refractory mantle cell lymphoma. The approval was based on the phase II ZUMA-2 trial in which 60 patients had an objective response rate (ORR) of 87% and a complete remission rate of 62%. Brexucabtagene autoleucel is a CD19-directed chimeric antigen receptor T-cell therapy.
The agency also granted an orphan drug designation to zenocutuzumab (Zeno; Merus) for patients with previously treated pancreatic cancer who have NRG1 mutations. The agent is a bispecific antibody that binds to HER2 and HER3; it is thought to block the interaction between HER3 and its ligand NRG1. Zenocutuzumab is under evaluation in the phase I/II eNRGy trial of NRG1-positive solid cancers.
Spectrum Pharmaceuticals announced that the EGFR inhibitor poziotinib may be effective in patients with previously treated NSCLC who have HER2 exon 20 insertion mutations. In the phase II ZENITH20 trial, 90 patients had an ORR of 27.8%, a disease control rate of 70%, and median progression-free survival of 5.5 months.
The IL6 inhibitor tocilizumab (Actemra; Roche) may not improve outcomes in patients with severe COVID-19 infections. In the phase III COVACTA trial, the agent did not meet its primary endpoint—improved health of patients hospitalized with severe COVID-19–associated pneumonia—or its secondary endpoint—reduced mortality after 4 weeks. In April, Sanofi/Regeneron reported similarly disappointing results in a randomized trial of the IL6 inhibitor sarilumab (Kevzara); IL6 inhibitors are also being investigated in various solid and blood cancers.
The American Cancer Society (ACS) released guidelines recommending cervical cancer screening with primary human papillomavirus (HPV) testing every 5 years starting at age 25. The new recommendation is based on evidence suggesting that fewer women in their early 20s are developing precancerous cervical lesions due to higher HPV vaccination rates, and cases of cervical cancer are rare between ages 20 and 24. Previously, the ACS recommended a Pap test every 3 years starting at age 21, transitioning to a Pap test plus HPV testing every 5 years at age 30.