AstraZeneca and Arcus Biosciences Pair Assets in NSCLC Study

Arcus Biosciences and AstraZeneca have partnered to evaluate a combination therapy as a potential treatment for advances non-small cell lung cancer (NSCLC).

Arcus will pair its investigational anti-TIGIT antibody domvanalimab (AB154) with AstraZeneca’s Imfinzi (durvalumab), a checkpoint inhibitor, in a Phase III study with patients who have unresectable Stage III NSCLC. Imfinzi is a human monoclonal antibody that binds to PD-L1 and blocks the interaction of PD-L1 with PD-1 and CD80 and is the only immunotherapy approved for patients with unresectable Stage III NSCLC, AstraZeneca said. The company touted Imfinzi as a game-changing drug in the treatment of Stage III NSCLS patients whose disease has not progressed following concurrent platinum-based chemotherapy and radiation therapy.

Arcus Chief Medical Officer Bill Grossman said the collaboration with AstraZeneca provides a unique opportunity for the development of domvanalimab. By combining domvanalimab with Imfinzi, which has become the standard of care in the curative-intent setting of unresectable Stage III NSCLC, Grossman said they anticipate this could maximize the impact of Arcus’ asset in this setting.

“With the aggressive development of our anti-TIGIT antibody in this additional setting, we are well positioned to be a leader in both the anti-TIGIT field and more broadly in the creation, development and commercialization of the next generation of innovative immuno-oncology combination therapies,” Grossman said in a statement.

José Baselga, AstraZeneca’s head of Oncology R&D, said the partnership with Arcus creates an important opportunity in the treatment of lung cancer. Baselga said this study will leverage the promise of Arcus’s anti-TIGIT antibody in Stage III NSCLC.

“This is a promising immunotherapy combination that has the potential to further enhance the efficacy and improvement of long-term survival that Imfinzi has already demonstrated in this setting, and to allow us to unlock the full potential of this medicine,” Baselga said in a statement.

In September, AstraZeneca released data from its Phase III PACIFIC study that showed treatment with Imfinzi following CRT led to unprecedented survival in unresectable Stage III NSCLC, with an estimated 50% of patients surviving four years versus 36% for CRT alone, and 35% of patients not progressing after four years versus 20% for CRT alone.

Arcus is currently evaluating domvanalimab, a new potential immuno-oncology backbone therapy in a three-arm randomized Phase II study, ARC-7, for first-line treatment of PD-L1-high metastatic NSCLC evaluating  the company’s own checkpoint inhibitor candidate zimberelimab as a monotherapy versus  domvanalimab with zimberelimab. The trial is also looking at domvanalimab plus etrumadenant (AB928), dual A2a/A2b adenosine receptor antagonist, with zimberelimab.

Under the terms of the agreement, each company will retain existing rights to their respective molecules and any future commercial economics. AstraZeneca will conduct the trial, and each company will supply its respective anti-cancer agent to support the trial. Pursuant to the terms of the agreement, the parties will share costs for the trial.

In May, Arcus teamed up with Gilead Sciences to evaluate domvanalimab and two other assets in oncology studies. Under terms of that deal, Gilead Sciences has an option to co-develop and co-commercialize domvanalimab. If Gilead exercises its option to domvanalimab, the trial from this AstraZeneca collaboration is expected to form part of the Arcus and Gilead joint development program and Arcus’ portion of the trial costs would be shared with Gilead.