BeOne Medicines announced on July 11 that on December 19, 2021, its wholly-owned indirect subsidiary, BeiGene Switzerland GmbH (hereinafter referred to as "BeOne Medicines Switzerland"), entered into an "Option, Collaboration and License Agreement" with Novartis Pharma AG (Novartis Group, hereinafter referred to as "Novartis"). According to the option agreement, BeOne Medicines Switzerland granted Novartis an exclusive, time-based option, allowing Novartis to obtain an exclusive license to develop, manufacture, and commercialize the company's investigational TIGIT inhibitor ociperlimab in certain countries and regions by exercising this option.
By mutual agreement, on July 10, BeiGene Switzerland GmbH and Novartis signed a "Mutual Termination and Release Agreement" to jointly terminate the Option Agreement. The termination agreement took effect immediately upon signing. After the termination agreement became effective, Novartis no longer holds the option rights, and BeiGene Switzerland GmbH has regained full global rights to develop, manufacture, and commercialize ociperlimab.
The company will continue to advance patient enrollment in the Phase 3 AdvanTIG-302 trial, which evaluates the combination of ociperlimab and the anti-PD-1 antibody tislelizumab as a first-line treatment for patients with locally advanced, unresectable, or metastatic non-small cell lung cancer (NSCLC) who have high PD-L1 expression and no sensitizing EGFR mutations or ALK translocations. Due to changes in treatment approaches, the company will discontinue the Phase 3 AdvanTIG 301 trial comparing ociperlimab plus tislelizumab with durvalumab for the treatment of patients with Stage III unresectable NSCLC following concurrent chemoradiotherapy (cCRT).
The company will carefully evaluate all available data to support the future development of ociperlimab. The termination of this agreement will not affect the $300 million cash upfront payment that BeiGene Switzerland GmbH previously received from Novartis, nor will it have a material adverse effect on the company's financial and operating conditions.