Faron Pharmaceuticals (AIM:FARN) told investors that final results from the metastatic melanoma cohort of its Phase 1/2 MATINS study have been accepted as an ePoster at the European Society for Medical Oncology Congress, taking place in Madrid from 23 to 27 October.
The Turku-based clinical-stage biopharmaceutical company develops immune-based cancer treatments, and the data mark the first report of complete survival outcomes for all 25 patients in the cohort, following interim results presented in 2022 and 2023.
The melanoma cohort comprised 25 patients with checkpoint inhibitor-refractory metastatic melanoma who received single-agent bexmarilimab at doses of 0.3 to 10 mg/kg every three weeks, all having failed prior anti-PD-1 therapy and 48% also having failed anti-CTLA-4 therapy.
The disease control rate was 20%, with median overall survival of 7.6 months; patients who achieved disease control had a median overall survival of 15.2 months against 6.2 months for those who did not, with 12-month survival rates of 80% and 35% respectively, though the company noted this difference did not reach statistical significance in a cohort of this size.
Treatment-emergent adverse events occurred in 96% of patients, including grade 3 or higher events in 56% and serious events in 44%, which Faron described as consistent with a heavily pretreated metastatic population; events related to bexmarilimab occurred in 36% of patients, most commonly fatigue.
Exploratory biomarker analysis found patients who achieved disease control had lower baseline serum interferon gamma than those who did not, and showed a median peak increase of 181% in the biomarker on treatment, which the company said is consistent with treatment-induced immune activation.
"What interests us most is the biology underneath it," said Petri Bono, Faron's chief medical officer. "The patients who benefited started with lower interferon gamma and their levels rose on treatment, which is what we would expect if bexmarilimab is reactivating an immune response that had been switched off."
MATINS tested bexmarilimab as a single agent, while the BLAZE trial, led by The Institute of Cancer Research, London, in partnership with The Royal Marsden NHS Foundation Trust, is evaluating bexmarilimab combined with the checkpoint inhibitor nivolumab in patients with acquired resistance to immunotherapy.
BLAZE enrols patients with metastatic non-small cell lung cancer and melanoma who have progressed on prior anti-PD-1 therapy, using a sequential design in which patients receive an initial run-in dose of bexmarilimab before transitioning to the combination with nivolumab.
Faron dosed the first patient in the BLAZE trial on 1 October.