FOSTER CITY (dpa-AFX) - Gilead Sciences Inc.'s (GILD) phase 2 EVOKE-02 Study of Trodelvy in combination with Merck & Co Inc.'s (MRK) Keytruda demonstrated promising clinical activity in first-line
The phase 2 EVOKE-02 study evaluated Trodelvy in combination with Merck's anti-PD-1 therapy Keytruda with or without platinum agents in patients with previously untreated advanced or metastatic non-small cell lung cancer or NSCLC without actionable genomic alterations.
According to Gilead, the preliminary analysis of the EVOKE-02 study included 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 greater 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.
Gilead noted that the data are very encouraging and confirms our approach for the ongoing Phase 3 EVOKE-03 study of Trodelvy in combination with Keytruda compared to Keytruda monotherapy for patients in first-line PD-L1-high metastatic NSCLC. The company noted that the safety profile of Trodelvy in combination with Keytruda in the EVOKE-02 study was consistent with the known safety of each agent. The most common any-grade TEAEs were diarrhea , anemia , and asthenia . Known key safety events for Trodelvy were not increased with the addition of Keytruda. The immune related adverse events were consistent with the known safety profile of Keytruda. Discontinuation rates due to adverse events were 18%.
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