Quote:That was not leronlimab but Agenus' Botensilimab/Balstilimab. They had been hoping for a path to accelerated approval but denied by FDA. They are conducting a phase 3 trial. Their CEO has written op-eds bashing FDA.
The trial that was based on had a 19% objective response rate in the best arm of the trial. With no mention of a complete response rate I'm guessing there wasn't one and that was all partial response rate. Median overall survival was 20.9 months with the best treatment (regorafenib, ipilimumab, nivolumab) hitting 27.5 months. Both drug combos had trials that excluded liver metastasis. Liver metastasis is often the cause of death in CRC.
The treatment related adverse events in the best arm of the trial were 87% with 35% being grade 3 or above. With those results the CEO has nothing to kick about in not getting accelerated approval.
Botensilimab downregulates CTLA-4. CTLA-4 is an immune suppressor that increases Tregs. Balstilimab. blocks PD-L1 binding. Leronlimab downregulates six immune suppressors that we know of, CTLA-4, TIM3, LAG3, sB7-H3, BAFF, sTyro3, the tumor growth factor - VEGF and blocks the driver of metastsis migration - CCL5.