Studies Will Investigate Novel Drug in Colon and Skin Cancer

A global, phase 2 program recently launched evaluating the novel drug botensilimab in two different clinical trials.

The ACTIVATE-Colorectal study will examine the drug in combination with balstilimab for patients with microsatellite stable colorectal cancer, while the ACTIVATE-Melanoma study will include single-agent botensilimab for patients with melanoma, a type of skin cancer.

Botensilimab, which works by activating the immune response to fight cancer, previously demonstrated anti-tumor effects in a phase 1 trial.

“The phase 1 botensilimab program demonstrated remarkable activity in poorly immunogenic and difficult to treat tumor types,” Dr. Steven O’Day, chief medical officer at Agenus, the manufacturer of the novel drug, said in a company-issued press release.

ACTIVATE-Colorectal

The colorectal cancer trial is a global study that will look at the safety, efficacy and optimal dose of botensilimab both alone and in combination with the PD-1 inhibitor, balstilimab.

To be eligible for enrollment, patients must have microsatellite stable colorectal cancer (cancer that does not have a deficiency in the DNA repair mechanism), have undergone at least one prior chemotherapy regimen, and did not receive a prior PD-1, CTLA-4 or other immune checkpoint inhibitor therapy.

The main goal of the trial is overall response rate, which is the percentage of patients whose disease shrunk as a result of treatment. Secondary goals of the study are duration of response, progression-free survival (time from treatment until disease progression) and overall survival (time from treatment until death of any cause).

ACTIVATE-Melanoma

The ACTIVATE-Melanoma trial will investigate the safety, efficacy and optimal dose botensilimab when given as a single agent (not administered in combination with other drugs) for patients with advanced refractory melanoma.

There will be two groups in this trial. Cohort A will include patients whose disease stopped responding to a prior anti-PD—1 therapy, while cohort B will include patients whose disease failed on both an anti-PD1 and anti-CTLA-4 therapy.

Overall response rate is also the main priority of this trial, with secondary goals being duration of response, progression-free survival and overall survival.

Researchers plan on launching another phase 2 trial to evaluate botensilimab in patients with pancreatic cancer later in 2022, according to the release.

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