SillaJen Demonstrates Efficacy in Combination Therapy of Pexavex and Livtayo

Shinilgen announced on the 27th that the Clinical Study Report (CSR) for the combination therapy of the oncolytic virus Pexa-Vec and Regeneron's immune checkpoint inhibitor Libtayo (generic name: cemiplimab) for metastatic or unresectable renal cell carcinoma (RCC, kidney cancer) has been completed.

Since the U.S. Food and Drug Administration (FDA) clinical approval in November 2017, Shinilgen and Regeneron initiated clinical trials at a total of 21 clinical sites across the United States, South Korea, and Australia. Earlier this year, the last patient completed the final drug administration, and the trial was concluded.

This clinical trial (Phase 1b/2a) was designed to confirm the safety and efficacy of the combination therapy of Pexa-Vec and Libtayo and consisted of four clinical cohorts (A to D). Among these, the cohorts (C and D) that received intravenous (IV) administration of the combination of Pexa-Vec and Libtayo demonstrated safety and efficacy.

Cohort C involved patients who had no prior experience with immune checkpoint inhibitor therapy and received intravenous Pexa-Vec combined with Libtayo, showing an objective response rate of 23.3% and an overall survival (OS) of 25.1 months. Cohort D, which combined intravenous Pexa-Vec and Libtayo in patients who had failed immune checkpoint inhibitor therapy, showed an objective response rate of 17.9%.

Notably, in cohort D, 22 out of 28 patients (78.6%) had previously undergone three or more lines of drug treatment, and 5 patients (17.9%) had two prior treatment experiences. Considering that in cancer clinical trials, patients with extensive treatment history typically show lower response rates, these clinical results can be regarded as very encouraging.

Accordingly, Shinilgen plans to actively explore cooperative strategies with its partner Regeneron, having secured efficacy across multiple indicators in this study.

A Shinilgen representative stated, “This new treatment approach of intravenous administration of an oncolytic virus combined with an immuno-oncology agent could offer a novel option for metastatic or unresectable renal cell carcinoma, where diverse treatment options are required. Based on these results, we plan to actively discuss various cooperation strategies, including licensing out, with our partner Regeneron.”

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