Swiss pharmaceutical giant Novartis AG (NYSE: NVS) has decided to terminate an option and license deal with China-based BeiGene (NASDAQ: BGNE, HKG: 6160, SHA: 688235), which was focused on the development of BeiGene’s TIGIT-targeted antibody drug, ociperlimab. The initial deal, signed in December 2021, included a USD 300 million upfront payment and potential milestone payouts of up to USD 745 million in regulatory approval milestones, and a further USD 1.15 billion in sales-based milestone payouts.
Implications for Ociperlimab’s Development and Commercialization
Had Novartis exercised its option, it would have taken over the development, manufacturing, and commercialization rights for ociperlimab in various territories across North America, Europe, and Japan. With the termination of the deal, BeiGene now regains full ownership of all development, manufacturing, and commercialization rights related to the investigational TIGIT inhibitor.
Continuation and Cancellation of Clinical Trials
BeiGene has stated that the development of ociperlimab will continue in the Phase III AdvanTIG-302 study, which assesses the TIGIT inhibitor in combination with the programmed death-1 (PD-1) inhibitor tislelizumab as a first-line treatment for locally advanced, unresectable, or metastatic non-small cell lung cancer (NSCLC) with high expression of PD-L1 and EGFR mutation or ALK translocation. However, the company will cancel another Phase III trial, the AdvanTIG 301 study, which was assessing ociperlimab in combination with tislelizumab and durvalumab in Stage III unresectable NSCLC after concurrent chemotherapy and radiotherapy (cCRT), reflecting changes in treatment norms for that type of NSCLC.
Mixed Signals in TIGIT Target Development
The decision comes amidst mixed signals regarding TIGIT as a target for drug developers. In February, Bristol-Myers Squibb (BMS) cancelled development on the Phase II stage anti-TIGIT med BMS-986207, citing safety signals when used in triple combination therapy with the CTLA-4 antibody Yervoy (ipilimumab) and PD-1 Opdivo (nivolumab). Meanwhile, Roche continues development of its anti-TIGIT candidate tiragolumab in NSCLC but halted development in extensive stage small-cell lung cancer in March. Roche also presented strongly positive data from a Phase II trial at this year’s ASCO meeting, assessing tiragolumab in combination with PD-L1 targeted Tecentriq (atezolizumab) and VEGF inhibitor Avastin (bevacizumab).-Fineline Info & Tech
