Studies Will Investigate Novel Drug in Colon and Skin Cancer

September 16, 2022
Brielle Benyon
Brielle Benyon

Brielle Benyon, Assistant Managing Editor for CURE®, has been with MJH Life Sciences since 2016. She has served as an editor on both CURE and its sister publication, Oncology Nursing News. Brielle is a graduate from The College of New Jersey. Outside of work, she enjoys spending time with family and friends, CrossFit and wishing she had the grace and confidence of her toddler-aged daughter.

Botensilimab will be evaluated in certain patients with colorectal cancer and melanoma, a type of skin cancer, in two recently launched clinical trials.

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.

For more news on cancer updates, research and education, don’t forget to subscribe to CURE®’s newsletters here.