In the Phase III ARTEMIS-008 study, 461 patients who had progressed following platinum-based chemotherapy were randomized to receive either risvutatug rezetecan or topotecan. At a median follow-up of 12.2 months, those receiving the novel therapy achieved a median overall survival of 18.5 months, compared to 10.3 months for the control group. Over 80% of the cohort had previously undergone treatment with PD-(L)1 inhibitors, highlighting the drug's potential for heavily pre-treated populations.

Beyond survival metrics, the drug outperformed topotecan across several secondary endpoints. Median progression-free survival reached 7.2 months with the experimental treatment versus 3.0 months with topotecan. Additionally, the objective response rate stood at 58.3% for the study group, significantly higher than the 12.6% observed in the control arm. Safety data also favored the new regimen, with Grade 3 or higher treatment-related adverse events reported in 60.9% of the risvutatug rezetecan group, compared to 78.2% for those receiving topotecan. Professor Jie Wang of the Chinese Academy of Medical Sciences noted that these findings suggest the drug could establish a new standard of care for relapsed small-cell lung cancer.