Agenus (AGEN) said Monday its combination of botensilimab and balstilimab demonstrated a two-year survival rate of 42% along with a new 21-month median overall survival in an expanded group of 123 participants with microsatellite-stable metastatic colorectal cancer without active liver metastases.

The confirmed objective response rate was 20% in heavily pretreated participants, while the median duration of response was about 17 months and the disease control rate was 69%, the company said.

No new safety signals were seen, immune-related side effects were manageable and there were no treatment-related deaths, the company said, adding that the combination was "tolerated" throughout dose levels.

Agenus said it has also reached a deal with the US Food and Drug Administration on the design of its global Battman phase 3 study, which is expected to start in Q4, while the regulator scrapped the botensilimab monotherapy arm requirement for the trial as the current result "appears to support" balstilimab's role in the combination's clinical activity and allowed for a two-arm study design.

Agenus said that during the July 1 discussion, it was asked by the FDA to carry out a randomized controlled study to support the approval of the combination in the metastatic setting, as the demonstrated magnitude of treatment effect "does not appear to meet the standard of reasonably likely to predict benefit", while the company "strongly" believes its treatment meets the benchmark in this patient group.

Shares of the company were down past 10% in recent Monday trading.

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