09.11.23
Gilead Sciences, Inc. reported promising early data from the global, open-label, Phase 2 EVOKE-02 study evaluating Trodelvy (sacituzumab govitecan-hziy) in combination with Merck’s anti-PD-1 therapy KEYTRUDA (pembrolizumab) with or without platinum agents in patients with previously untreated advanced or metastatic non-small cell lung cancer (NSCLC).
Preliminary analysis of the 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 ≥ 50% and < 50%. In Cohort A, confirmed and unconfirmed objective response rate (ORR) was 69%, and disease control rate (DCR) 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 (DoR) was not reached at the time of data cut-off, and DoR rate at six months was 88% in both cohorts.
“The EVOKE-02 trial is the first data presented from several Gilead studies dedicated to exploring Trodelvy’s potential in lung cancer,” said Bill Grossman, senior vice president, therapeutic area head, Gilead Oncology. “These data are very encouraging and confirms our approach for the ongoing Phase 3 EVOKE-03 study of Trodelvy in combination with KEYTRUDA vs. KEYTRUDA monotherapy for patients in first-line PD-L1-high metastatic NSCLC. We look forward to potentially bringing a new treatment option to previously untreated metastatic NSCLC patients.”
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.
Preliminary analysis of the 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 ≥ 50% and < 50%. In Cohort A, confirmed and unconfirmed objective response rate (ORR) was 69%, and disease control rate (DCR) 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 (DoR) was not reached at the time of data cut-off, and DoR rate at six months was 88% in both cohorts.
“The EVOKE-02 trial is the first data presented from several Gilead studies dedicated to exploring Trodelvy’s potential in lung cancer,” said Bill Grossman, senior vice president, therapeutic area head, Gilead Oncology. “These data are very encouraging and confirms our approach for the ongoing Phase 3 EVOKE-03 study of Trodelvy in combination with KEYTRUDA vs. KEYTRUDA monotherapy for patients in first-line PD-L1-high metastatic NSCLC. We look forward to potentially bringing a new treatment option to previously untreated metastatic NSCLC patients.”
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.