ROCHESTER, N.Y., Nov. 09, 2019 (GLOBE NEWSWIRE) — Vaccinex, Inc. (NASDAQ:VCNX), a clinical-stage biotechnology company pioneering novel investigational antibody therapies in cancer and Huntington's disease, today announced that updated interim data of the Phase 1b/2 study of pepinemab in combination with anti-PD-L1 checkpoint inhibitor, BAVENCIO® (avelumab), in non-small cell lung cancer (NSCLC) is being reported during a poster presentation on Saturday, November 9 at the 34th Annual Meeting of The Society for Immunotherapy of Cancer (“SITC”). Below is a summary of updated interim data from the poster presentation.
Updated Interim Data
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 SITC, 59% of patients (17/29) whose tumors had progressed during or following treatment with FDA-approved checkpoint inhibitors appeared to benefit from switching to the combination of pepinemab + avelumab, which appeared to induce a halt or reversal of tumor progression. Notably, half of these patients who benefited from the combination of pepinemab + avelumab had been treated with Keytruda® and 25% had been treated with Opdivo® prior to enrolling in this clinical trial. Two patients had partial responses (PR) with 63% and 52% tumor reductions on combination therapy after progression on Keytruda®, and 15 patients experienced stable disease (SD) , including 3 who had been refractory to prior anti-PDx therapy. To date, 1 subject (PR) has been on study for one year, 4 subjects (1PR+3SD) have been on study for at least 26 weeks and an additional 5 subjects with stable disease for at least 16 weeks.
Among 21 evaluable immunotherapy naïve patients enrolled, 5 subjects experienced a partial response following treatment with pepinemab plus avelumab. A total of 3 subjects have experienced durable clinical benefit for > 1 year at data cutoff and an additional 5 subjects have been on study for at least 26 weeks. The Disease Control Rate (PR+SD) is 81%.
Importantly, comparative analysis of available pre-treatment and on-treatment biopsies in a subset of subjects indicate that there is increased CD8+ T cell influx into tumors following combination therapy in patients experiencing a partial response (5/5) or stable disease (4/5), suggesting a favorable treatment-related change in the tumor micro-environment. Tumor was absent or greatly reduced in on-treatment biopsies from these subjects.
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, …
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