Noted This Week

September 11–17

Gilead will acquire Immunomedics for $21 billion. In the deal, Gilead will gain Immunomedics’ antibody–drug conjugate (ADC) sacituzumab govitecan-hziy, which is FDA approved for triple-negative breast cancer. A monoclonal antibody against human trophoblast cell-surface antigen 2 conjugated to the topoisomerase I inhibitor SN-38, the agent is being tested in bladder cancer, non–small cell lung cancer, and other solid tumors.

The American Association for Cancer Research released its inaugural Cancer Disparities Progress Report. The report "will provide the world with a comprehensive baseline understanding of our progress towards understanding and eliminating cancer health disparities," said John Carpten, PhD, of the University of Southern California’s Keck School of Medicine in Los Angeles, who led the steering committee that developed it. The report covers topics such as social inequities in access to care, the role of biology in creating disparities, the need for greater diversity in clinical trials, and how COVID-19 may be contributing to cancer disparities.

The FDA approved Roche’s CINtec PLUS Cytology test to determine which women require more immediate follow-up after testing positive for high-risk types of human papillomavirus. The test detects p16 and Ki-67 biomarkers associated with a higher risk of developing cancer. The approval was based on the IMPACT trial, which enrolled 35,000 women to validate the test.

The agency also released a guidance on resuming manufacturing of drugs and biologics during the COVID-19 pandemic. The document outlines how to evaluate and prioritize manufacturing activities that were delayed, reduced, or modified during the pandemic to restart production of therapies and avoid shortages. It offers suggestions to address deviations from established manufacturing procedures and developing a manufacturing plan that factors in another possible wave of COVID-19.

Merck will pay Seattle Genetics $125 million up front and up to $65 million more in milestone payments to co-develop and sell Seattle Genetics’ ADC ladiratuzumab vedotin; they plan to assess the agent in combination with Merck’s anti–PD-1 agent pembrolizumab (Keytruda) in breast cancer and other solid tumors. Merck will also gain exclusive rights to sell Seattle Genetics’ tyrosine kinase inhibitor tucatinib (Tukysa) in Asia, the Middle East, and Latin America.

Researchers have confirmed what many suspected based on anecdotal evidence: Patients with lung cancer are experiencing changes in their treatment plans due to the COVID-19 pandemic. Researchers analyzed 211 patients with lung cancer who were receiving active treatment and found that 57% experienced at least one change to their treatment plan; 9% had more than one change. Treatment alterations included delaying or stopping palliative chemotherapy, adjusting therapy dose or schedule, or delaying or canceling surveillance visits.


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