NEW YORK – Novartis said on Monday that it has inked an option, collaboration, and licensing deal with BeiGene for the TIGIT inhibitor ociperlimab.
Under the terms of the deal, Novartis will pay BeiGene $300 million upfront. BeiGene is eligible to receive another $700 million if the option is exercised before late 2023. The option would give Novartis the rights to develop and commercialize ociperlimab in the US, Canada, Mexico, the EU, the UK, and a number of other countries. BeiGene, meanwhile, will retain rights to ociperlimab in China and all other regions. In the US specifically, BeiGene and Novartis would evenly co-commercialize the drug.
During the option period, Novartis and BeiGene will collaborate on clinical trials to explore the activity of ociperlimab with tislelizumab — the PD-1 inhibitor that Novartis licensed from BeiGene in early 2021 and now owns rights to develop in North America, Europe, and Japan. Novartis will sponsor, fund, design, and conduct these combination therapy trials. Previous research has shown that the TIGIT pathway is associated with resistance to PD-1 checkpoint inhibitors, making TIGIT a target with the potential to improve the benefit of anti-PD-1 therapy when given concurrently.
BeiGene is currently evaluating ociperlimab — also called BGB-A1217 — in two Phase III clinical trials for advanced non-small cell lung cancer as well as in other trials for various solid tumors. Specifically, in AdvanTIG-301, the firm is randomizing roughly 900 patients with stage III, treatment-naïve NSCLC to one of three treatment arms. In one arm, patients will receive ociperlimab, tislelizumab, and concurrent chemoradiotherapy; in another, they will get tislelizumab and chemoradiotherapy; and in the third, patients will receive just chemo.
In the AdvanTIG-301 trial, BeiGene will track patients' progression-free survival outcomes and complete response rates on the various regimens and evaluate if patients' PD-L1 and TIGIT expression levels can predict treatment benefit.
In the AdvanTIG-302 trial, meanwhile, the firm is randomizing around 600 patients with treatment-naïve, advanced NSCLC whose tumors express PD-L1 in at least 50 percent of cells to receive either the ociperlimab-tislelizumab combination, tislelizumab alone, or Merck's PD-1 inhibitor pembrolizumab (Keytruda). Investigators will evaluate patients' progression-free and overall survival outcomes. They will also prospectively assess how PD-L1 expression levels play into patients' outcomes and retrospectively analyze the same for other biomarkers.
Beyond AdvanTIG-301 and AdvanTIG-302, the ociperlimab development program spans six clinical trials in lung cancer, esophageal squamous cell carcinoma, and cervical cancer. According to Novartis, about 600 patients have enrolled in these trials to date.
In addition to the ociperlimab deal, Novartis and BeiGene also announced on Monday that they have formed a partnership to expand Novartis' reach in China. Specifically, BeiGene will promote several Novartis cancer drugs in regions in China where Novartis doesn't already have a commercial presence.