PV-10 well-tolerated in treatment of refractory cutaneous melanoma

Intralesional injection of rose bengal disodium was well-tolerated in patients with refractory cutaneous melanoma, with just over half of patients meeting the primary study endpoint, according to a poster presented at the European Society of Medical Oncology Annual Congress.

Researchers included 80 patients with 6.3-cm median sum lesion diameter in biopsy-confirmed melanoma that was refractory to a median of six previous interventions in the study. The patients received intralesional injections of rose bengal disodium (PV-10) in up to 20 cutaneous and subcutaneous lesions up to four times during a 16-week period. Follow-up was 52 weeks.

The researchers assessed best overall response rate (BORR) in up to 10 injected target lesions, and secondary endpoints included the assessment of response duration, BORR of untreated bystander lesions, overall survival and adverse events.

PV-10 was found to be well-tolerated, and 41 patients achieved the study’s primary endpoint of an objective response for an overall response rate of 51%.

Among a subgroup of patients who had received PV-10 treatment in all existing lesions, overall response rate was 71%, with a complete response rate of 50%, according to the researchers.

A total of 54 patients, including those in the all-treatment subgroup, had a complete response in 232 of 363 injected lesions.

The researchers found 121 lesions required a single injection to achieve complete response, whereas 84 required two injections, 22 required three injections, and five required four injections.

Ten of 28 uninjected bystander lesions also achieved complete response, according to the researchers.

Reference:

Agarwala SS. Abstract #1120P. Presented at: the ESMO Annual Congress. Sept. 26-30, 2014; Madrid, Spain.