Risvutatug Rezetecan Improves Survival in Relapsed Small-Cell Lung Cancer

Risvutatug Rezetecan, a B7-H3-directed antibody-drug conjugate, has shown significant promise in the treatment of relapsed small-cell lung cancer (SCLC), according to results from the Phase III ARTEMIS-008 trial. The trial, conducted by the International Association for the Study of Lung Cancer (IASLC) and presented at the IASLC 2026 World Conference on Lung Cancer, demonstrated that Risvutatug Rezetecan reduced the risk of death by 54% compared to topotecan, a standard chemotherapy treatment.

The multicenter, open-label, randomized Phase III study involved 461 patients in China who had relapsed SCLC and had progressed after platinum-based chemotherapy. Patients were randomized 1:1 to receive either Risvutatug Rezetecan at 8.0 mg/kg every three weeks or topotecan at 1.2 mg/m² on days 1 through 5 every three weeks. The primary endpoint was overall survival, with key secondary endpoints including progression-free survival, objective response rate, and disease control rate.

At the June 6, 2026, data cutoff, after a median follow-up of 12.2 months, the median overall survival was 18.5 months for patients receiving Risvutatug Rezetecan, compared to 10.3 months for those receiving topotecan. Risvutatug Rezetecan also showed a median progression-free survival of 7.2 months, compared to 3.0 months for topotecan. The objective response rate was 58.3% for Risvutatug Rezetecan and 12.6% for topotecan, while the disease control rate was 90.4% and 60.2%, respectively.

The study also found that grade 3 or higher treatment-related adverse events occurred less frequently with Risvutatug Rezetecan than with topotecan, at 60.9% versus 78.2%. The most common grade 3 or higher treatment-related adverse events were hematologic toxicities, including decreased neutrophil count, decreased white blood cell count, anemia, decreased lymphocyte count, and decreased platelet count.

The ARTEMIS-008 trial (NCT06498479) is part of a broader effort to improve outcomes for patients with SCLC, a type of lung cancer known for its aggressive nature and poor prognosis. The findings from this trial could have significant implications for the treatment of this disease, potentially offering a more effective and safer alternative to current therapies.

The IASLC, the world's largest meeting dedicated to lung cancer and other thoracic malignancies, aims to increase awareness, collaboration, and understanding of lung cancer and help participants implement the latest developments in the field. The WCLC, the conference where these results were presented, attracts nearly 7,000 researchers, physicians, and specialists from over 100 countries.