Gilead’s EVOKE-02 study of Trodelvy, KEYTRUDA combo shows promise in NSCLC

Gilead Sciences, Inc. announced early data showcasing promising clinical activity of Trodelvy in combination with Merck’s KEYTRUDA for first-line treatment of metastatic non-small cell lung cancer (NSCLC). The data was presented at the IASLC 2023 World Conference on Lung Cancer and focuses on patients without actionable genomic alterations.

EVOKE-02 Preliminary Analysis: Notable Response Rates Across Cohorts

The preliminary analysis includes two different cohorts based on PD-L1 tumor proportion score (TPS). Cohort A showed a confirmed and unconfirmed objective response rate (ORR) of 69% and a disease control rate (DCR) of 86%. In Cohort B, the ORR was 44% and DCR was 78%. Across both cohorts, the median duration of response (DoR) had not been reached at the time of data cut-off, and the DoR rate at six months was 88% in both cohorts.

“Patients with metastatic NSCLC continue to need novel treatment options. The data from the EVOKE-02 study gives us confidence in the clinical activity of sacituzumab govitecan in combination with pembrolizumab in first-line metastatic NSCLC patients,” said Byoung Chul Cho, MD, PhD, Professor in the Division of Medical Oncology at Yonsei Cancer Center.

Implications and Future Studies for Trodelvy and KEYTRUDA Combination

Bill Grossman, Senior Vice President at Gilead Oncology, emphasized the importance of these findings for future research. “These data are very encouraging and confirms our approach for the ongoing Phase 3 EVOKE-03 study of Trodelvy in combination with KEYTRUDA for patients in first-line PD-L1-high metastatic NSCLC,” Grossman stated.

Safety Profile and Collaboration with Merck

The safety profile for the Trodelvy and KEYTRUDA combination was consistent with each agent’s known safety profiles. Common any-grade adverse events included diarrhea, anemia, and asthenia. Gilead entered into clinical trial collaborations with Merck in January 2022 for the Phase 2 EVOKE-02 and the ongoing Phase 3 EVOKE-03 studies in first-line NSCLC.

Trodelvy’s Current Approvals and Ongoing Reviews

Trodelvy is approved in almost 50 countries for the treatment of adult patients with unresectable locally advanced or metastatic triple-negative breast cancer. It’s also approved in the U.S. and the EU for certain patients with pre-treated HR+/HER2- metastatic breast cancer. Regulatory reviews are currently underway worldwide.

The results of the EVOKE-02 study present a new avenue in the treatment of first-line metastatic NSCLC, offering hope for more effective and well-tolerated treatment options.