As the 2021 American Society of Clinical Oncology (ASCO) Annual Meeting presents many clinical trial updates, there appears to be a theme: access to drugs and pricing.
An experimental Bristol Myers Squibb drug from a new class of immunotherapy used in combination with the company’s big-selling cancer medicine Opdivo significantly extended the time it took for advanced melanoma to worsen compared with Opdivo alone, according to early data from a study released on May 19.
Merck announced positive results from the late-stage KEYNOTE-522 study for Keytruda as a neoadjuvant treatment for triple negative breast cancer, which should support the company’s previous attempt for U.S. approval that was stymied by a regulatory advisory committee in February and rejected by the Food and Drug Administration in March.
A U.S. Food and Drug Administration committee gave the nod to continue using Genentech’s checkpoint inhibitor Tecentriq in combination with chemotherapy to treat adults with unresectable locally advanced or metastatic triple-negative breast cancer (mTNBC) whose tumors express PD-L1.
The U.S. Food and Drug Administration approved GlaxoSmithKline’s new checkpoint inhibitor, Jemperli (dostarlimab), for patients with recurrent or advanced endometrial cancer.
Bristol Myers Squibb announced topline data from the Phase III CheckMate -648 trial on April 8, with positive results in esophageal cancer.
Aveo Oncology announced on March 12 a clinical trial collaboration and supply deal to study Fotivda in combination with Bristol Myers Squibb’s checkpoint inhibitor Opdivo (nivolumab) in advanced r/r RCC after previous immunotherapy exposure.
Six former FDA commissioners – Scott Gottlieb, Robert Califf, Mark McClellan, Margaret Hamburg, Jane Henney and Andrew von Escehenbach – signed a joint letter urging the U.S. president to nominate a permanent commissioner soon.
Two weeks after AstraZeneca announced the company was withdrawing the use of Imfinzi as a treatment for bladder cancer in the United States, Swiss pharma giant Roche followed suit with the checkpoint inhibitor Tecentriq (atezolizumab).
Merck presented new data from the Phase III CLEAR trial (KEYNOTE-581/Study 307) at the virtual 2021 Genitourinary Cancers Symposium of the company’s checkpoint inhibitor Keytruda (pembrolizumab) and Eisai’s tyrosine kinase inhibitor Lenvima (lenvatinib) in renal cell carcinoma.
