Gilead presents early data from Phase 2 EVOKE-02 study

Gilead Sciences (GILD) announced early data from the global, open-label, Phase 2 EVOKE-02 study evaluating Trodelvy in combination with Merck’s (MRK) anti-PD-1 therapy KEYTRUDA with or without platinum agents in patients with previously untreated advanced or metastatic non-small cell lung cancer without actionable genomic alterations. The results were presented at the IASLC 2023 World Conference on Lung Cancer hosted by the International Association for the Study of Lung Cancer. The preliminary analysis of the EVOKE-02 study includes results of two cohorts: Trodelvy in combination with KEYTRUDA in first-line advanced or metastatic squamous/non-squamous NSCLC with PD-L1 tumor proportion score greater than or equal to 50% and TPS less than 50%. In Cohort A, confirmed and unconfirmed objective response rate was 69%, and disease control rate was 86%. In Cohort B, confirmed and unconfirmed ORR was 44%, and DCR was 78%. Across both cohorts, the ORR was 56%, and DCR was 82%. Median duration of response was not reached at the time of data cut-off, and DoR rate at six months was 88% in both cohorts. The safety profile of Trodelvy in combination with KEYTRUDA in the EVOKE-02 study was consistent with the known safety of each agent. The immune related adverse events were consistent with the known safety profile of KEYTRUDA. Discontinuation rates due to adverse events were 18%. One treatment related death was observed due to sepsis. Gilead entered into two clinical trial collaboration and supply agreements with Merck in January 2022 to evaluate the combination of Trodelvy and Merck’s KEYTRUDA in the Phase 2 EVOKE-02 signal-seeking study and the ongoing Phase 3 EVOKE-03 study in first-line NSCLC.