CEL-SCI announces potential impact on Multikine following FDA ODAC meeting

CEL-SCI (CVM) announced the potential impact on the clinical development of its immunotherapy Multikine resulting from a recent FDA Oncologic Drugs Advisory Committee, or ODAC, meeting, a public forum. FDA advisory committees provide independent expert advice to the FDA on the safety and effectiveness of new and marketed drugs and help the agency make sound and informed decisions. Advisory committees make non-binding recommendations to the FDA, which generally follows the recommendations but is not legally bound to do so. The September 27 ODAC meeting evaluated the use of checkpoint inhibitors on patients with various cancers. PD-L1 is the biomarker most often used for patient selection for checkpoint inhibitors, the most successful class of cancer drugs including Keytruda and Opdivo. The FDA sought the ODAC’s opinion on the following: adequacy of PD-L1 expression as a predictive biomarker for patient selection in this patient population; differing risk-benefit assessments in different subpopulations defined by PD-L1 expression; adequacy of the cumulative data to restrict the approvals of immune checkpoint inhibitors based on PD-L1 expression. Following a thorough analysis of peer-reviewed published data, the panel of experts on the ODAC voted 10-2 and 11-1 against the risk-benefit profile for PD-L1 inhibitors in various cancers in two separate votes. Most ODAC members expressed concerns about the lack of benefit demonstrated for patients with low PD-L1 expression, while some members pointed to evidence that the use of the immune checkpoint inhibitors may add unnecessary toxicities for patients while also increasing financial burdens on patients.