Gilead Shares Drop 9% as Trop2 ADC Trodelvy Fails Phase 3 NSCLC Trial

On January 22, 2024, Gilead Sciences announced the latest data from the Phase III clinical trial EVOKE-01 of its new Trop2ADC drug Trodelvy for the treatment of non-small cell lung cancer. The study did not meet the primary endpoint of overall survival (OS). This study compared Trodelvy with docetaxel chemotherapy in patients who had progressed after platinum-based chemotherapy and immune checkpoint therapy.

Compared with the control group, Trodelvy showed a numerical advantage in OS but did not reach statistical significance. In the subgroup of patients non-responsive to PD-1/PD-L1, OS was extended by more than 3 months. However, in the subgroup of patients responsive to PD-1/PD-L1, there was no difference in OS. Gilead Sciences plans to further explore the clinical value of Trodelvy for these patients.

Summary

Trodelvy is the world's first approved Trop2ADC, initially approved for the treatment of triple-negative breast cancer and urothelial carcinoma. However, it failed in the more significant indication of non-small cell lung cancer. Following this news, Gilead Sciences' stock price fell by 9% today, dropping its market value below $100 billion. Meanwhile, the new generation of Trop2ADC has caught up, with Kelun Biotech's SKB264 already submitting an application for marketing authorization for triple-negative breast cancer. Phase III clinical trials for EGFR-mutant non-small cell lung cancer and HR+/HER2- breast cancer are also progressing actively.

Editor: Bai Ji

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