Updated Results From KEYNOTE-695 Do Not Meet ORR Primary Endpoint in Advanced Melanoma

Source: Targeted Oncology, April 2023

Primary results from the phase 2 KEYNOTE-695 study (NCT03132675) did not meet the prespecified end point of overall response rate (ORR) for previously treated patients with unresectable or metastatic (Stage III/IV) melanoma to the combination of pembrolizumab (Keytruda) and a proprietary interleukin 12 (IL–12) intratumoral tavokinogene telseplasmid and electroporation (TAVO-EP).

The encoding plasmid in combination with the anti-PD-1 therapy is meant for patients who had a confirmed disease progression after at least 12 weeks of exposure to a prior anti-PD-1 therapy like pembrolizumab or nivolumab monotherapy.

In this trial, there was a total of 98 efficacy evaluable patients that had at least 1 post-baseline tumor assessment with a confirmed ORR per RECIST v1.1 by blinded independent central review (BICR) assessment of 10.2% (95% CI, 5%-17.97%).