Vaccinex to Present Updated Results from CLASSICAL-Lung, Phase 1b/2 Study of Pepinemab (VX15/2503) in Combination with Avelumab (BAVENCIO) in Non-Small Cell Lung Cancer at the American Society of Clinical Oncology (ASCO) 2020 Annual Meeting

Data continue to demonstrate durable response in patients as trial nears completion

ROCHESTER, N.Y., May 13, 2020 (GLOBE NEWSWIRE) -- Vaccinex, Inc. (Nasdaq: VCNX), a clinical-stage biotechnology company pioneering a differentiated approach to treating cancer and neurodegenerative disease through the inhibition of SEMA4D, today announced a poster presentation highlighting interim results from CLASSICAL-Lung, the Company’s Phase 1b/2 study of pepinemab in combination with the anti-PD-L1 checkpoint inhibitor BAVENCIO (avelumab) in non-small cell lung cancer (NSCLC), at the American Society of Clinical Oncology (ASCO) 2020 Annual Meeting, being held virtually May 29-31, 2020.

“We are pleased to announce that updated data from the CLASSICAL-Lung trial of combination treatment with pepinemab and avelumab confirms earlier signs of anti-tumor activity, most notably in patients for whom  previous treatment with anti–PD-1/PD-L1 therapies failed and those who have PD-L1–negative or –low tumors,” said Dr. Maurice Zauderer, President and CEO of Vaccinex. “We believe this uniquely positions pepinemab to help the many patients with NSCLC who do not respond to PDx therapies, and we are looking forward to continuing to advance pepinemab through development.” 

Details on Vaccinex’s poster discussion presentation at ASCO:

Abstract Number: 3011
Title: Interim subgroup analysis for response by PD-L1 status of CLASSICAL-Lung, a phase 1b/2 study of pepinemab (VX15/2503) in combination with avelumab in advanced NSCLC
Session: Developmental Therapeutics – Immunotherapy
Presenter: Michael Rahman Shafique, M.D., Department of Thoracic Oncology, Moffitt Cancer Center and Research Institute
Date: Available on demand beginning May 29 at 8:00 a.m. EDT.

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. Avelumab is co-developed and co-commercialized by Merck KGaA, Darmstadt, Germany and Pfizer Inc. The data to be presented at ASCO demonstrate that 59% (17/29) of patients who were either refractory (3/17) or whose tumors progressed (14/17) during or following treatment with single agent checkpoint inhibitor benefited from switching to the combination therapy, demonstrating that adding pepinemab to an immunotherapy (IO) treatment regimen has the potential to halt or reverse tumor progression. Additionally, 81% of immunotherapy-naïve patients  (17/21) have experienced disease control, either a partial response (5 patients) or stable disease (12 patients), while receiving the combination. Six IO naïve and 4 IO failure patients have experienced durable clinical benefit of greater than six months. Tumor biopsies show increased T cell infiltration and reduced tumor burden in both patients who experienced a partial response or stable disease. Notably, 97% of patients who demonstrated a partial response or stable disease had negative or low PD-L1 expression in the tumor, demonstrating that adding pepinemab to an immunotherapy treatment regimen has the potential to expand the patient population for whom immunotherapy could be beneficial. The combination of pepinemab and avelumab has been demonstrated to be well-tolerated at all dose levels tested.