Rilvegostomig for Metastatic Non-Small Cell Lung Cancer: A First-In-Human Phase I/II Clinical Study.
Kristoffer S Rohrberg, Mariana Brandão, Eduardo Castañón Álvarez et al.
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In 30 seconds
This first-in-human, multicenter, open-label phase I/II study evaluated rilvegostomig, a bispecific antibody targeting PD-1 and TIGIT, in patients with PD-L1-positive advanced or metastatic non-small cell lung cancer previously treated with checkpoint inhibitors. The study assessed safety, pharmacology and preliminary antitumour activity across dose escalation and expansion. At the recommended phase II dose of 750 mg every 3 weeks, the objective response rate was 5.6%, the 6-month disease control rate was 31.5%, and median progression-free survival was 3.8 months. Investigators reported tolerability and supported further evaluation.
Key findings
- No dose-limiting toxicities occurred, and the maximum tolerated dose was not reached; the recommended phase II dose was 750 mg once every 3 weeks.
- At the recommended dose, objective response rate was 5.6%, 6-month disease control rate was 31.5%, and median progression-free survival was 3.8 months.
- Treatment-related adverse events occurred in 54.2% of patients, including grade 3 events in 8.4%; treatment-related discontinuations were 2.4%.
Why it matters
The study provides early clinical data on a bispecific checkpoint-targeting antibody in checkpoint inhibitor-experienced patients, a population with advanced disease after prior immunotherapy. The response and disease-control findings indicate preliminary antitumour activity, while the reported adverse-event and discontinuation rates inform assessment of tolerability. These results support continued investigation but do not establish comparative benefit.
What to keep in mind
This was an open-label, early-phase study with preliminary antitumour activity assessed in a pretreated population; the abstract reports no comparator group.