Provectus updates data on cancer immunotherapy PV-10 for uveal melanoma

Provectus provided updated data from an ongoing Phase 1 clinical trial of investigational cancer immunotherapy PV-10 – rose bengal sodium – for the treatment of uveal melanoma metastatic to the liver. mUM patients enrolled in this study received 1 or more cycles of PV-10 injection into 1 or more hepatic metastases. Where indicated, standard of care immune checkpoint blockade, as either monotherapy pembrolizumab or the combination of ipilimumab and nivolumab, was also administered. To date, 25 mUM patients have received monotherapy PV-10 or PV-10 in combination with CB. Acceptable safety was observed, with no mortality or permanent Grade 3 or higher morbidity attributed to study treatment. 1 patient achieved complete response – 4% -, 7 patients achieved partial response – 28% -; 32% objective response rate, and 8 patients achieved stable disease – 32% -; 64% disease control rate. Median overall survival of all patients was 11.0 months. All CMR patients are alive after a median follow-up of 39 months – 3.3 years -, range 24.6-61.6 months. mOS has not been reached yet, and CMR patients represent 24% of M1a patients and 16% of all patients. To confirm these initial results, additional M1a patients in a dedicated study cohort will receive PV-10 in combination with standard of care ipilimumab and nivolumab.