– Results Show Encouraging Activity of Trodelvy in Combination with KEYTRUDA in 1L Metastatic NSCLC Across all PD-L1 Subgroups and Histologies Studied –

– Results Support Further Investigation of Trodelvy in Combination with KEYTRUDA in 1L Metastatic NSCLC–

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 (TPS) ≥ 50% (Cohort A) and TPS < 50% (Cohort B). In Cohort A (n=29), confirmed and unconfirmed objective response rate (ORR) was 69%, and disease control rate (DCR) was 86%. In Cohort B (n=32), 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.

“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, Yonsei University College of Medicine. “The positive response rates and duration of response across patients treated with the combination shows promise compared with historical responses to anti-PD1 monotherapy in this setting. These data support further investigation of sacituzumab govitecan as a potential IO-combination option in first-line metastatic NSCLC.”

“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, MD, PhD, 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.”

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 (54%), anemia (48%), and asthenia (38%). 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%. One treatment related death was observed due to sepsis.

Gilead entered into two clinical trial collaboration and supply agreements with Merck (known as MSD outside of the United States and Canada) 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.

The use of Trodelvy for the treatment of NSCLC and the use of Trodelvy in combination with KEYTRUDA for any use is investigational, and the safety and efficacy for these uses have not been established or approved by any regulatory agency globally. Trodelvy has a Boxed Warning for severe or life-threatening neutropenia and severe diarrhea; please see below for additional Important Safety Information.