MaaT Pharma Initiates Phase 2 Trial Combining Microbiome Therapy and Immunotherapy in Lung Cancer

Overview of the IMMUNOLIFE Trial

According to the press release, the IMMUNOLIFE trial is a randomized, multicenter study promoted by Gustave Roussy that will enroll 162 patients with advanced non-small cell lung cancer. These patients have shown resistance to PD-1/PD-L1 blockade after receiving antibiotics and suffer from intestinal dysbiosis induced by these treatments. Participants are randomized in a 1:1 ratio to receive either MaaT033 orally for one week before each cycle of cemiplimab, administered every three weeks for six months then as monotherapy, or the best treatment chosen by the investigator. The primary objective of the study is to assess whether this combination improves the disease control rate at 12 weeks compared to standard treatment. The study involves 14 centers in France with recruitment planned over approximately 2 years and a total treatment duration with cemiplimab of up to 2 years.

Expected Results and Study Timeline

According to the group, primary results after one year of post-treatment follow-up could be expected by the end of 2030. An interim futility analysis is scheduled for the first half of 2027, after the randomization of the 81st patient. This study is part of the IMMUNOLIFE consortium, which includes leading academic institutions such as Gustave Roussy, INSERM, Université Paris-Saclay, INRAe, and the Institut Hospitalo-Universitaire Méditerranée Infection, as well as biotechnology companies. The consortium is funded by the French National Research Agency. The trial is coordinated by Dr. Lisa Derosa, investigator at Gustave Roussy, and aims to address the challenge of primary resistance to immune checkpoint inhibitors observed in patients with advanced non-small cell lung cancer after antibiotic use.

Update on Related Study and Strategic Implications

The company has been informed by the academic promoter of the PICASSO study that the main results will not be available in the fourth quarter of 2025 as previously announced and are now expected in the first half of 2026. This randomized controlled Phase 2a trial, promoted by AP-HP in Paris, evaluates Xervyteg in combination with the immune checkpoint inhibitors ipilimumab and nivolumab in patients with metastatic melanoma. According to MaaT Pharma, the IMMUNOLIFE and PICASSO studies are part of an exploratory trial strategy launched in 2022 and aim to refine the research strategy particularly in terms of indication, treatment line, and target population. These data will also feed the company's artificial intelligence platform and support the development of MaaT034, a next-generation co-cultured microbiome therapy developed to target high-volume indications in solid tumors.