Vaccinex Presents Updated Interim Data from Phase 1b/2 Study

Vaccinex (NASDAQ:VCNX) has announced updated interim data for its Phase 1b/2 study of pepinemab in combination with anti-PD-L1 checkpoint inhibitor BAVENCIO in non-small cell lung cancer (NSCLC).

As quoted in the press release:

The CLASSICAL-Lung trial is being conducted in collaboration with Merck KGaA, Darmstadt, Germany.  It is a multi-center, open-label study designed to evaluate the safety and potential efficacy of the combination of pepinemab and avelumab in subjects with advanced NSCLC. In the interim data presented at CICON , 59% of patients (17/29) whose tumors had progressed during or following treatment with FDA-approved checkpoint inhibitors (50% received Keytruda) appeared to benefit from switching to the combination of pepinemab + avelumab, which appeared to induce a halt or reversal of tumor progression.  Among the 17 responders, two had partial responses with 49% and 37% tumor reductions on combination therapy after failure of pembrolizumab, and 15 experienced stable disease. In a second cohort of immunotherapy naïve patients (n=18), 5 subjects experienced a partial response following treatment with pepinemab plus avelumab, 3 subjects have experienced durable clinical benefit for > 1 year at data cutoff, and the Disease Control Rate (PR+SD) is 81%.

Importantly, comparative analysis of available pre-treatment and on-treatment biopsies suggest that there is increase CD8+ T cell influx into tumors following combination therapy in patients experiencing a partial response (6/6) or stable disease (4/6), indicating a favorable treatment-related change in the tumor micro-environment. Furthermore, tumor was absent or greatly reduced in on-treatment biopsies from subjects who had partial responses (6/6) or stable disease (5/6).

No concerning safety signals with the combination of pepinemab and avelumab have been identified by investigators to date. One dose limiting toxicity (DLT), a grade 3 pulmonary embolism, occurred. This resolved and did not recur in that same subject or additional subjects in any cohort. In addition, there have been no dropouts or discontinuations due to toxicity.

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