FDA rejects accelerated approval for Agenus colorectal cancer drug
While the FDA has agreed on the phase 3 dosing regimen for Agenus' BOT/BAL immunotherapy combination for relapsed/refractory microsatellite stable colorectal cancer (r/r MSS CRC), it has advised against seeking accelerated approval, the company announced this week.
The FDA's recommendation includes adding a BOT monotherapy arm in the phase 3 study. Interim phase 2 data showed an overall response rate (ORR) of 19.4% and a six-month survival rate of 90%, consistent with phase 1 results. Agenus plans to present phase 2 data at an upcoming medical conference.
Additionally, Agenus is scheduling a meeting with the European Medicines Agency in Q3 2024 to explore approval pathways for BOT/BAL in Europe. The company is also advancing BOT/BAL development for other cancers, including lung, melanoma, and pancreatic cancers.
BOT/BAL is a combination of two immunotherapy drugs, botensilimab (BOT) and balstilimab (BAL). Botensilimab is a CTLA-4 blocking antibody designed to enhance both innate and adaptive anti-tumor immune responses by activating T cells, reducing regulatory T cells in tumors, activating myeloid cells, and inducing long-term memory responses. Balstilimab is a PD-1 antibody that enhances immune response against cancer by blocking the PD-1 pathway, which tumors use to evade immune detection.