LEXINGTON, MASS. -- Agenus Inc. (Nasdaq: AGEN), a leader in immuno-oncology innovation, announced that France’s National Agency for Medicines and Health Products Safety (ANSM) has approved an updated national treatment protocol for botensilimab (BOT) plus balstilimab (BAL) under France’s Autorisation d’Accès Compassionnel (AAC) framework.

The updated protocol expands France’s previously granted AAC authorization for BOT+BAL in patients with microsatellite-stable (MSS) metastatic colorectal cancer (mCRC) without active liver metastases to eligible patients with certain ovarian cancers and soft-tissue sarcomas—diseases with substantial unmet medical need after standard options have been exhausted.

The revised protocol is designed to broaden the eligibility criteria, allowing more patients with advanced solid tumors to have early access to BOT+BAL under reimbursed compassionate use, and to enhance monitoring and treatment procedures in participating hospitals.

BOT+BAL is a chemotherapy- and radiation-free immunotherapy combination being evaluated in clinical studies and available in compassionate access settings authorized by ANSM. In studies conducted to date, antitumor activity has been observed in heavily pretreated patients, including in tumor types that have historically shown limited responsiveness to standard immunotherapy approaches.

France’s AAC pathway enables hospital-based access for patients with serious or life-threatening diseases who lack appropriate therapeutic alternatives. Treatment under AAC is governed by a national protocol that standardizes the conditions of use, including patient eligibility, treatment administration, effectiveness and safety data collection and follow-up under France’s national health system oversight.

For eligible French patients treated in hospital under AAC, BOT+BAL is fully reimbursed.

Expanded AAC eligibility

Under the updated national protocol, reimbursed AAC access to BOT+BAL is authorized in France for eligible adult patients with:

· MSS metastatic colorectal cancer without active liver metastases, following progression on standard therapies;
· Platinum-refractory or platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer, after exhaustion of approved treatment options; and
· Advanced or metastatic soft-tissue sarcomas, including multiple high-grade histologies, following failure of standard therapies.

Significance of the update

By extending fully reimbursed AAC access across colorectal cancer, ovarian cancer, and sarcoma, France has implemented a multi-tumor early access framework for a single investigational immunotherapy combination under one nationally standardized protocol. This represents an uncommon level of national early-access authorization and enables consistent hospital access to an investigational treatment while maintaining ANSM oversight and structured patient follow-up as additional clinical and real-world evidence continues to develop.

BOT+BAL remains investigational and is not approved for commercial marketing in France or elsewhere.