Gilead Sciences, Inc. announced detailed results from the Phase 3 EVOKE-01 study that will be presented during an oral session (Abstract #LBA8500) on 2:45-5:45pm CT) at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting. The results were also published simultaneously in the Journal of Clinical Oncology. The company previously announced that the study did not meet the primary endpoint of overall survival (OS) in previously treated metastatic non-small cell lung cancer (NSCLC).

EVOKE-01, evaluating Trodelvy® (sacituzumab govitecan-hziy; SG) vs. docetaxel, showed a 16% reduction in the risk of death (median OS: 11.1 vs. 9.8 months; HR: 0.84; 95% CI: 0.68-1.04; 1-sided p=0.0534) in patients with metastatic or advanced NSCLC that had progressed on or after platinum-based chemotherapy and anti-PD-(L)1-therapy.

This numerical improvement in OS was observed consistently across both squamous and non-squamous histology. In patients with high unmet medical need whose tumors did not respond to last anti-PD-(L)1-containing treatment, a meaningful OS improvement of 3.5 months was seen when treated with Trodelvy vs. docetaxel (mOS: 11.8 vs.

8.3 months; HR: 0.75; 95% CI: 0.58-0.97). This subgroup represents approximately 2/3 of the study population. This pre-specified subgroup analysis was not alpha-controlled for formal statistical testing.

For the subgroup of patients whose mNSCLC was responsive to last anti-PD-(L)1-containing treatment, median OS was 9.6 vs. 10.6 months when treated with Trodelvy vs. docetaxel (HR: 1.09; 95% CI: 0.76-1.56).

In the overall study population numerically more patients were alive at 12-months when treated with Trodelvy compared to docetaxel (46.6% vs. 36.7%). In the study, Grade =3 adverse events (AEs) were lower among patients receiving Trodelvy (66.6%) vs.

docetaxel (75.7%), and AEs leading to discontinuation were lower with Trodelvy (9.8%) vs. docetaxel (16.7%). The most common AEs of any grade for Trodelvy were fatigue (57%), diarrhea (53%), and alopecia (43%) and for docetaxel were fatigue (56%), neutropenia (43%) and diarrhea (34%).

Patients treated with docetaxel had a greater incidence of neutropenia of any grade compared with Trodelvy (43% vs. 38%, respectively), while patients treated with Trodelvy experienced more diarrhea of any grade vs. docetaxel (53% vs.

34%, respectively). The safety profile for Trodelvy was consistent with prior studies, with no new safety signals identified in this patient population. In addition to the EVOKE-01 presentation at the 2024 ASCO Annual Meeting, Gilead will present data from its broader lung cancer clinical development program.

Longer-term results from Cohort A of the Phase 2 EVOKE-02 study of Trodelvy in combination with KEYTRUDA® (pembrolizumab) in first-line metastatic PD-L1 =50% NSCLC will also be presented in a poster session (Abstract #8592) on June 3, 2024. These data show a median progression-free survival (PFS) of 13.1 months and support promising activity in this patient population in both squamous and non-squamous histologies. These data continue to support ongoing Phase 3 EVOKE-03 study in PD-L1-high mNSCLC.

In addition, Gilead has a broad clinical development program in lung cancer with domvanalimab, the first Fc-silent investigational anti-TIGIT antibody, and the investigational anti-PD-L1, zimberelimab. Trodelvy is the first approved Trop-2-directed antibody-drug conjugate (ADC) that has demonstrated meaningful survival advantages in two different types of metastatic breast cancers and shown improved clinical outcomes for certain people with 2L advanced or metastatic urothelial cancer. Trodelvy has not been approved by any regulatory agency for the treatment of metastatic NSCLC.

Its safety and efficacy have not been established for this indication. Trodelvy has a Boxed Warning for severe or life-threatening neutropenia and severe diarrhea; please see below for the approved U.S. Indication and additional Important Safety Information.