Microbiotica reported that five of 41 patients with advanced melanoma had an objective response in a Phase 1b MB097 trial, in which its investigational microbiome treatment was given alongside Merck’s Keytruda. The company presented the results at the European Society for Medical Oncology congress in Madrid in October 2026.
Key Takeaways
- Three of 21 patients given vancomycin preconditioning responded, as did two of 20 patients without it.
- Microbiotica said MB097 was safe and well tolerated with Keytruda, with no serious adverse effects related to MB097.
MB097 trial results by treatment arm
The MELODY-1 study enrolled patients whose advanced melanoma had not responded to prior anti-PD-1 antibody therapy. Participants were randomized to receive either five days of the antibiotic vancomycin, followed by a two-day washout, or no antibiotic preconditioning. Both groups then received MB097 and Keytruda for 24 weeks.
In the vancomycin group, all three patients who responded had reductions of more than 75% in target lesion dimensions, including one complete response. The company said bacterial engraftment was particularly strong in that group.
Both groups received the combination treatment, so the reported results do not isolate MB097’s effect from that of Keytruda. Microbiotica said the study met all its primary and secondary endpoints.
| Item | Details |
|---|---|
| Vancomycin preconditioning | 3 of 21 patients responded (14%); one had a complete response. |
| No antibiotic preconditioning | 2 of 20 patients responded (10%). |
Treatment and follow-up
MB097 is an oral, once-daily investigational treatment containing nine bacterial strains. Keytruda, also known as pembrolizumab, is an anti-PD-1 therapy made by Merck.
All 41 patients have completed the MB097 treatment phase and a 12-week safety follow-up. Patients with disease control were eligible to continue Keytruda after the initial treatment period.
Next milestone
Microbiotica is continuing MB097 through a Phase 1b extension and expects to generate additional data from that phase.
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