161 0 Kommentare Agenus Unveils New and Updated Botensilimab Data in Colorectal, Pancreatic, Lung, Melanoma, and Sarcoma

Agenus Inc. (Nasdaq: AGEN), a leader in developing novel immunological agents to treat cancers, today announced first-time and updated data from its ongoing botensilimab/balstilimab (BOT/BAL) clinical programs in advanced colorectal cancer (CRC), neoadjuvant CRC, pancreatic cancer, non-small cell lung cancer (NSCLC), melanoma, and sarcoma. Members of the Agenus leadership team along with key opinion leaders will discuss these findings during a live webcast at 1:00 p.m. EDT (19:00 CEST) at a corporate event at the European Society for Medical Oncology 2023 Conference.

“These new and updated data underscore BOT’s broad effectiveness across several advanced solid tumors, demonstrating its potential beyond first-generation immunotherapies and current treatments,” said Dr. Steven O’Day, Chief Medical Officer. “BOT’s versatility, alone, in combination with BAL, or in combination with other standard of care therapies, in early and late-stage solid tumors, positions Agenus to transform cancer care, offering immense promise to patients.”

Key highlights across solid tumors include:

Extended Follow-up and Additional Data in Refractory MSS CRC Demonstrate Improved Responses and Durability

In 70 efficacy evaluable patients with MSS CRC and no active liver metastases:

Confirmed (RECIST 1.1) overall response rate (ORR) of 24% was observed, compared to 2.8% reported with standard of care (SOC) in 2/3L+ MSS CRC patients with no active liver metastases¹.
12-month overall survival (OS) of 74% and median OS (mOS) not yet reached. Median follow up now 12.3 months.

Subsequent data from expanded cohorts and early signals from a 230 patient Phase 2 trial is consistent with the earlier cohort of 70 patients. Based on the totality of the evidence from the Phase 1 and Phase 2 trials, Agenus plans to submit its Biologics License Application (BLA) to the U.S. Food & Drug Administration (FDA) for BOT/BAL in patients with 2/3L+ MSS CRC in midyear 2024. Interactions with U.S. and EU regulatory agencies are ongoing.

Robust Clinical Outcomes in Neoadjuvant MSS CRC Underscore BOT/BAL’s Potential in Earlier-Stage Patients*

All patients treated with one dose of BOT and two doses of BAL.
After dosing, observations of responses were made within approximately four-weeks prior to surgery.
100% (3/3) of patients with MSI-H CRC had major pathological responses (>90%).
67% (6/9) patients with MSS CRC had pathological responses of >50%, which includes two complete pathological responses.
These findings offer an alternative path to minimize or eliminate radical rectal surgery and its associated morbidities such as colostomy dependance and sexual dysfunction, and potentially avoid the need for systemic chemotherapy.
Agenus plans to prioritize neoadjuvant development and is evaluating study design for further regulatory activity.