Interim Data from Phase I/II CLASSICAL-Lung Trial Shows Signs of Efficacy in Advanced NSCLC

Apr 5, 2019 | Cancer, Cancer Clinical Trials, Non-Small Cell Lung Cancer, Positive Results

Cancer Drug

Vaccinex presented at 2019 Annual Meeting of the American Association for Cancer Research, demonstrating the combination of pepinemab with avelumab is effective and well tolerated to date in the ongoing phase I/II CLASSICAL-Lung trial.

CLASSICAL-Lung is an open label, single arm, first-in-human combination study is designed to evaluate the safety, tolerability and efficacy of pepinemab in combination with avelumab in 62 subjects with advanced (IIIB/IV) non-small cell lung cancer (NSCLC). The trial is split into dose escalation (n=12) and dose expansion (n=50) phases. The dose escalation portion includes patients who are immunotherapy naïve and have either progressed or declined standard first or second-line systemic anticancer therapy.  Patients in the dose escalation cohorts received ascending doses of pepinemab (5, 10, 20 mg/kg, every two weeks {Q2W}) in combination with avelumab (10mg/kg, Q2W). The expansion phase includes a similar patient cohort as well as a second cohort of patients whose tumors progressed during or following immunotherapy.

The combination therapy was shown to be well tolerated at all dose levels. The most common adverse events were fatigue, pyrexia and chills. The recommended Phase 2 Dose was selected as 10 mg/kg of pepinemab Q2W with 10 mg/kg avelumab Q2W. Immunogenicity did not appear to be a concern. The Disease Control Rate (DCR) for all dose escalation patients was 75% and for subjects treated for at least two months the DCR was 90%.

About advanced NSCLC

NSCLC is the most common type of lung cancer. About 85% of lung cancers are NSCLC. In people with NSCLC, the cancer may spread from the lungs to other parts of the body. This is called advanced NSCLC. This type of cancer is also known as metastatic or stage 4 lung cancer.

 About pepinemab

Pepinemab is an IgG4 humanized monoclonal antibody targeting semaphorin 4D (SEMA4D, CD100). Sema4D is highly expressed in certain types of tumors and functions in the regulation of tumor angiogenesis and growth.

About avelumab

Avelumab Is a fully human anti-PD-L1 IgG1 antibody and inhibits PD-L1-PD-1 interactions. It has been approved by the FDA as Bavencio for the treatment of both Merkel cell and urothelial carcinomas. Merck and Pfizer manufacture avelumab.

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