What's Happening?
Gilead Sciences and Arcus Biosciences have decided to discontinue their late-stage study of the investigational TIGIT drug domvanalimab. This decision follows a futility analysis by an independent data panel, which found the drug's performance in combination
with a PD-1 blocker and chemotherapy for metastatic non-small cell lung cancer (NSCLC) to be ineffective compared to Merck's Keytruda plus chemotherapy. The trial, known as STAR-121, did not reveal any new safety issues, but the lack of efficacy has led Gilead to roll back its cancer collaboration with Arcus. Gilead will not make an option continuation payment, effectively ending its access to early-stage TIGIT therapies from Arcus. However, Gilead retains time-limited options on other programs, including the small-molecule AXL blocker AB801 and the anti-CD39 antibody AB598.
Why It's Important?
The discontinuation of the domvanalimab trial marks a significant setback for Gilead and Arcus, highlighting the challenges faced in the development of TIGIT therapies. The decision underscores the financial risks associated with high-stakes pharmaceutical collaborations, as companies have invested heavily in TIGIT programs with limited returns. The failure of the trial could impact investor confidence and influence future strategic decisions in the immuno-oncology sector. Additionally, the broader implications for patients with NSCLC are significant, as the search for effective treatments continues amidst these setbacks.
What's Next?
With the end of the STAR-121 trial, Gilead and Arcus will need to reassess their strategies in the oncology space. Gilead's decision to retain certain program options suggests a continued, albeit cautious, interest in exploring other therapeutic avenues. The pharmaceutical industry will likely monitor these developments closely, as the outcome may influence future collaborations and investments in similar drug development programs. Stakeholders, including investors and patients, will be keenly interested in how Gilead and Arcus navigate this setback and what new directions they might pursue.
