FDA Grants Fast Track Designation to Botensilimab Plus Balstilimab in Non–MSI-H/dMMR mCRC

On April 17, 2023, the combination of botensilimab (AGEN1181) and balstilimab (AGEN2034) has been granted fast-track designation by the FDA for the treatment of patients with non-microsatellite instability-high (MSI-H)/mismatch repair-deficient (dMMR) metastatic colorectal cancer (mCRC) with no active liver involvement.

The designation is intended for patients who have received a VEGF inhibitor, an EGFR inhibitor, and/or a BRAF inhibitor and are resistant or intolerant to fluoropyrimidine, oxaliplatin, and irinotecan. A phase 2 trial (NCT05608044) is currently underway to compare botensilimab monotherapy and in combination with balstilimab to standard-of-care therapy in patients with unresectable mCRC who have previously received chemotherapy for metastatic or recurrent disease. In 2023, a global phase 3 trial evaluating the combination in patients with non-MSI-H CRC is scheduled to begin.

About Agenus

Agenus is a clinical-stage immuno-oncology company dedicated to the discovery and development of therapies that use the body’s immune system to combat cancer and infections. The Company’s vision is to increase the number of patients who benefit from cancer immunotherapy by pursuing combination approaches that leverage a diverse repertoire of antibody therapeutics, adoptive cell therapies (via its subsidiary MiNK Therapeutics), and adjuvants (via its subsidiary SaponiQx). The company has a suite of antibody discovery platforms as well as a state-of-the-art GMP manufacturing facility that can support clinical programs. Agenus’ headquarters are in Lexington, Massachusetts.

For more information, please visit: Botensilimab Plus Balstilimab in Non–MSI-H/dMMR mCRC

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