Armenia grants first-ever approvals for Agenus cancer drug combination

Agenus Inc. (NASDAQ: AGEN) announced that Armenia's Ministry of Health has granted marketing authorizations for Botvymo® (botensilimab) and Evamplix® (balstilimab), each approved for use in combination with the other, marking the first such approvals for either medicine anywhere in the world.

The approvals, effective October 2, 2026, cover adult patients with microsatellite stable (MSS) metastatic colorectal cancer without active liver metastases who have previously received available standard therapies. Each authorization is conditional and valid for one year, renewable based on annual clinical updates provided to Armenian regulators.

Under the approved dosing regimen, Botvymo is administered at 75 mg intravenously every six weeks for up to four doses, in combination with Evamplix at 240 mg intravenously every two weeks for up to two years, or until disease progression or unacceptable toxicity.

The approvals followed a review of a complete registration dossier submitted in the international Common Technical Document format used under Eurasian Economic Union rules, covering product quality and manufacturing, nonclinical data, clinical efficacy and safety, and the pharmacovigilance system. The supporting clinical evidence includes data from the Phase 1b C-800-01 study and the randomized Phase 2 C-800-25 study, with results published in Nature Medicine and Clinical Cancer Research.

"Patients who have exhausted standard treatments now have a new option, and we are proud to bring it to them," said Garo H. Armen, PhD, Chairman and Chief Executive Officer of Agenus.

Agenus stated it will evaluate potential marketing authorization submissions for the combination in other Eurasian Economic Union member countries. The Armenian authorizations apply only within Armenia's territory.

In France, the combination is available through the national Autorisation d'Accès Compassionnel program for eligible patients with MSS metastatic colorectal cancer, platinum-resistant ovarian cancer, and certain advanced soft-tissue sarcomas. BAP Pharma serves as Agenus' global partner for the French access pathway and named-patient programs in other countries.

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