Insilico Medicine reported on October 26, 2026, that two of five evaluable mesothelioma patients responded to a 130 mg daily dose of its experimental cancer drug ISM6331 in an ongoing Phase 1 study. The company plans to complete dose selection before deciding whether to advance to a Phase 2a trial.

Key Takeaways

  • The 40% response rate at 130 mg was based on five evaluable mesothelioma patients.
  • Across doses of 30 to 130 mg, four of 22 evaluable mesothelioma patients responded.
  • No dose-limiting toxicities were reported at doses from 15 to 130 mg.

Insilico Medicine trial results

ISM6331 is an investigational oral drug designed with Insilico’s Chemistry42 generative AI platform. The company presented the first-in-human findings at the European Society for Medical Oncology Congress 2026 in Madrid.

The study had enrolled 36 participants across doses of 15 to 130 mg as of the August 14, 2026 data cutoff. Participants had received a median of two prior treatment lines, with a range of one to 12.

At 130 mg once daily, the two patients who responded had target-lesion reductions of 58% and 36%. Across the 30 to 130 mg cohorts, the objective response rate among evaluable mesothelioma patients was 18.2%, while the disease control rate was 68.2%.

Three of the four partial responses across those cohorts were ongoing at the cutoff, including one lasting approximately a year. The small patient groups mean the reported response rates are preliminary.

Safety and development plans

Insilico said no treatment-related adverse events led to discontinuation, and most were grade 1 or 2. Grade 3 treatment-related adverse events occurred in 8.3% of participants, including asymptomatic increases in amylase and lipase, fatigue and drug dermatitis.

Treatment-related proteinuria occurred in 11.1% of participants and was low-grade and reversible, the company said. Dose escalation remains ongoing.

The US Food and Drug Administration granted ISM6331 orphan drug designation for mesothelioma in June 2024 and fast track designation in July 2026.

Next milestone

Insilico plans to complete Phase 1 dose selection and, subject to emerging data, start a randomized Phase 2a dose-optimization study in mesothelioma.

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