MaaT Pharma: in melanoma, MaaT013 well tolerated but with no gain in response rate
MaaT Pharma commented on November 6, 2026 on the first data from a Phase 2a trial sponsored by AP-HP in metastatic melanoma, following their publication on the European clinical trials portal CTIS.
The Lyon-based biotech indicates that these results will inform its immuno-oncology development strategy, in particular for another of its candidates, MaaT034.
No significant difference in severe toxicity between the two arms
The PICASSO trial, sponsored and conducted by AP-HP in collaboration with INRAE and Gustave Roussy, evaluated MaaT013 (Xervyteg) in combination with ipilimumab and nivolumab. The enrolled patients had advanced, unresectable or metastatic melanoma and had never received immunotherapy. The study was randomized and placebo-controlled.
Its primary objective, which concerned the safety and feasibility of administration, was met. No statistically significant difference was observed between the two arms in the incidence of grade 3 or higher adverse events. The safety profile was “globally consistent” with that expected for this combination of immunotherapies.
In total, 70 patients were randomized at five centers in France. The analysis covered 69 of them: 34 in the MaaT013 arm and 35 in the placebo arm. The trial is fully funded by the Directorate General for Healthcare Provision and operated by INCa, the company having supplied the product and the placebo.
Response rates comparable to those of the placebo arm
In terms of efficacy, response rates, one of the main secondary endpoints, were comparable in the MaaT013 and placebo arms. They remain consistent with those previously reported for the combination of ipilimumab and nivolumab. The treatment, however, was associated with a significant increase in the richness and diversity of the microbiota compared with placebo.
Exploratory analyses suggest that the composition of the microbiota before treatment could influence the clinical response to MaaT013, which, according to the company, justifies further investigation. These preliminary data do not constitute a definitive scientific publication: the complete results will be presented by the investigators at an upcoming congress.
For Hervé Affagard, Chief Executive Officer and co-founder, these results “provide additional insight into the importance of the therapeutic context and patient selection.” According to him, they will help inform the group's strategy, “in particular in the development of MaaT034 in patients refractory to ICIs” (immune checkpoint inhibitors).
This candidate is intended for solid tumors. On October 19, 2026, following a meeting held prior to filing a clinical trial application, the company had indicated that the US health authority did not anticipate additional nonclinical studies on its safety.
