SillaJen Reveals Clinical Results of Pexastimogene Devacirepvec and Livtayo Combination at ESMO

Shinilgen announced on the 24th that it presented the research results of the combination therapy of 'Pexa-Vec' for metastatic or unresectable renal cell carcinoma (RCC, kidney cancer) and Regeneron's immune checkpoint inhibitor 'Libtayo (generic name: cemiplimab)' at the 'European Society for Medical Oncology Annual Meeting (ESMO 2023)' held in Madrid, Spain from the 20th to the 24th (local time).

[Photo by Shillajen]

The combination clinical trial results were presented as a poster on the 23rd. The phase 1b/2a trial was designed to confirm the safety and efficacy of the combination therapy of Pexa-Vec and Libtayo, consisting of four clinical cohorts (A to D). Among them, the clinical cohorts (C and D) that received intravenous (IV) administration of Pexa-Vec and Libtayo in combination demonstrated confirmed safety and efficacy.

Specifically, in cohort C, which involved patients without prior immune checkpoint inhibitor treatment receiving intravenous administration of Pexa-Vec and Libtayo, an objective response rate (ORR) of 23.3% and an overall survival (OS) of 25.1 months were observed. In cohort D, which involved patients who had failed immune checkpoint inhibitor treatment receiving intravenous administration of Pexa-Vec and Libtayo, an ORR of 17.9% was observed.

Notably, cohort D consisted of 22 out of 30 patients (78.6%) who had experienced three or more prior drug treatments. Considering that patients with extensive prior treatment history typically show lower response rates in cancer clinical trials, these results are encouraging. Additionally, since cohorts C and D received Pexa-Vec only once weekly for four doses, it is expected to be advantageous for commercialization compared to chemotherapy agents that require continuous administration.

A Shinilgen representative stated, “Through this trial, we were able to confirm the synergistic effect of the intravenously administered oncolytic virus and immune checkpoint inhibitor,” and added, “Based on these results, we plan to actively discuss collaboration strategies with our partner Regeneron.”

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