Gilead Sciences (Gilead) has announced positive results from the fourth interim analysis its ARC-7 study. The research involves patients with metastatic non-small cell lung cancer (NSCLC) with a PD-L1 tumour proportion score of less than 50% without epidermal growth factor receptor or anaplastic lymphoma kinase mutations.
ARC-7 is a phase 2, multi-location, three-arm, randomised study evaluating the combinations of domvanalimab plus anti-PD-1 monoclonal antibody zimberelimab and domvanalimab plus zimberelimab and etrumadenant.
Efficacy was evaluated in patients who had at least 13 weeks of follow-ups, making them potentially eligible for at least two imaging scans, while safety was analysed among all enroled patients. With a median follow-up time of approximately 12 months, both the doublet and triplet combinations demonstrated clinically meaningful improvements in median progression-free survival (PFS).
There were also six-month landmark survival rates compared to zimberelimab monotherapy, with a 45% reduction in risk of disease progression or death for the doublet and 35% for the triplet.
The domvanalimab-containing study arms also demonstrated clinically meaningful improvements in objective response rate compared to zimberelimab monotherapy.
Confirmed overall response rate was 27%, 41% and 40% for the zimberelimab monotherapy arm and the domvanalimab doublet and triplet arms, respectively. The triplet arm did not show an improvement over the doublet arm, however, it appeared to reinforce the results observed in the doublet arm.
Melissa Johnson, lead investigator for the ARC-7 study, explained: “It is particularly encouraging to see that combination treatments may offer potentially meaningful advances for people with non-small cell lung cancer based on the largest, prospectively randomised phase 2 study of anti-TIGIT and anti-PD1 antibodies to date.”
She added: “The preliminary improvements observed for each of the doublet and triplet regimens across multiple efficacy measures reinforce our confidence in the potential therapeutic benefit of inhibiting the TIGIT pathway and provide further support for the ongoing phase 3 studies.”
The study will continue to monitor PFS, as well as overall survival, for the triplet arm as the data matures.
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