Agenus (AGEN) Tanks on Colorectal Cancer Study Interim Data

Company Overview - Agenus Inc. (AGEN) shares fell 58.8% on July 18 following the FDA's discouragement of the accelerated approval pathway for its immunotherapy combination botensilimab (BOT) and balstilimab (BAL) in treating relapsed/refractory microsatellite stable colorectal cancer (r/r MSS CRC) [1] - The FDA indicated that the objective response rate (ORR) from the phase II study may not translate into a survival benefit [1] Clinical Study Results - Interim data from a phase II study showed that the BOT/BAL combination at a dose of 75 mg BOT and 240 mg BAL achieved an ORR of 19.4%, with 90% of patients alive at this dosage [1] - The FDA has agreed on the dosing regimen for a phase III study, which includes BOT (75 mg) every six weeks for up to four doses and BAL (240 mg) every two weeks for up to two years [2] Future Developments - The FDA has proposed including a BOT monotherapy arm in the phase III study, and Agenus is seeking a partner in the U.S. for this study [2] - Apart from colorectal cancer, the BOT/BAL combination has shown clinical activity in other cancer types, including lung cancer, melanoma, and pancreatic cancers [3] Market Performance - Year-to-date, Agenus shares have declined 55.9%, contrasting with a 1.4% decline in the industry [2]