Abstract
A collection of recently published news items.
Cellectis announced the FDA placed a hold on the MELANI-01 trial evaluating UCARTCS1A, an off-the-shelf chimeric antigen receptor (CAR) T-cell therapy to treat relapsed/refractory multiple myeloma, after a patient died from cardiac arrest. Studies of two other off-the-shelf CAR T-cell therapies are continuing.
Genentech and Amgen settled two court cases involving biosimilars. Genentech filed the lawsuits to try to prevent Amgen from selling its trastuzumab biosimilar, trastuzumab-anns (Kanjinti), and its bevacizumab biosimilar, bevacizumab-awwb (Mvasi), in the United States. Genentech claimed that Amgen did not provide adequate notice before commercializing the drugs, but a federal court affirmed a lower court's decision in favor of Amgen in both cases.
The U.S. Court of Appeals for the Federal Circuit upheld a ruling that two U.S. scientists should be listed as inventors on six cancer immunotherapy patents. 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 previously issued to Ono Pharmaceutical and Tasuku Honjo, MD, PhD, of Kyoto University in Japan. The patents describe the PD-1 pathway, which was foundational to the development of the PD-1 inhibitor nivolumab (Opdivo; Bristol-Myers Squibb).
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 that cases of cervical cancer are rare before age 25 (CA Cancer J Clin 2020 July 30 [Epub ahead of print]).
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 develop and commercialize DS-1062, a TROP2-directed antibody–drug conjugate being tested in non–small cell lung cancer and triple-negative breast cancer.
For more news on cancer research, visit Cancer Discovery online at http://cancerdiscovery.aacrjournals.org/CDNews.