Novartis, Bristol-Myers Squibb Partner To Test Combo Treatments For NSCLC

Novartis announced that it has linked arms with Bristol-Myers Squibb to jointly conduct clinical trials investigating the combination of three of Novartis’ compounds with Bristol-Myers Squibb’s Opdivo (nivolumab) in patients with non-small cell lung cancer (NSCLC).

Under the terms of the agreement, three molecularly targeted compounds from Novartis, namely Zykadia, INC280, and EGF816, will be tested together with Opdivo (nivolumab), an investigational PD-1 immune checkpoint inhibitor. Zykadia is an FDA-approved treatment for patients with anaplastic lymphoma kinase-positive (ALK+) metastatic NSCLC. The company recently reported positive data from its pivotal study showing that the drug significantly extended progression-free survival in patients with lung cancer. INC280 is a selective inhibitor of c-MET receptor tyrosine kinase while EGF816 is a third-generation EGFR tyrosine kinase inhibitor that fights T790 mutations.

Novartis will take the lead in conducting Phase 1/2 trials. One trial will assess Zykadia with Opdivo while the second will evaluate Opdivo with INC280 and EGF816 separately in NSCLC.

Alessandro Riva, Global Head of Novartis Oncology Development and Medical Affairs, said, “Preclinical data suggests that combining molecularly targeted agents with immunotherapies such as nivolumab may have synergistic effects and lead to better outcomes for patients. This collaboration enables us to study several key compounds, including our new highly-potent ALK inhibitor Zykadia, together with a promising, novel immunotherapy agent, paving the way for potential new treatment approaches for patients with NSCLC.”

Michael Giordano, SVP of Oncology Development at BMS, said, “Combining Opdivo with select targeted agents from Novartis complements our broad global development strategy of immuno-oncology combinations across the spectrum of lung cancer settings, and supports our goal of improving outcomes for patients. We look forward to working with Novartis to fully explore how the combination of these agents can potentially advance care for lung cancer patients.”

Last month, BMS announced that the U.S. Food and Drug Administration (FDA) accepted its Biologics License Application (BLA) for priority review. The European Medicines Agency (EMA) also accepted its Marketing Authorization Application for accelerated assessment.