Trodelvy Fails to Impress in Phase III NSCLC Trial, Raises Questions About Asian Patient Populations

The pharmaceutical company Gilead Sciences, in collaboration with Merck & Co., recently terminated its Phase III EVOKE-03 clinical trial for the treatment of non-small cell lung cancer (NSCLC) due to disappointing results. The trial aimed to evaluate the efficacy and safety of combining Trodelvy, a TROP2-targeting antibody-drug conjugate (ADC), with Keytruda, an immunotherapy drug, in first-line NSCLC patients.

Although the combination therapy extended progression-free survival (PFS) from 7.7 months to 11.8 months, the overall survival (OS) was not significantly improved, with a hazard ratio (HR) of 0.81, which did not reach statistical significance. Furthermore, the OS for Chinese patients in the trial showed an HR of 0.65, indicating that they benefited more from Trodelvy.

The termination of the EVOKE-03 trial raises questions about the generalizability of clinical results obtained from Chinese patient populations to the global population. The phenomenon of better clinical outcomes in Asia has been observed in several recent studies, including those on ADCs and immunotherapy drugs.

One possible explanation for the disparity is that Asian patients may be more sensitive to TROP2 ADC or have different disease characteristics compared to European and American patients. Additionally, differences in treatment regimens across regions may also contribute to variations in benefit.