EVOKE-01 Metastatic NSCLC Study Results at ASCO 2024

Gilead Sciences, Inc. has announced detailed outcomes from its Phase 3 EVOKE-01 study, which will be presented at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting. This study assessed the efficacy of Trodelvy® (sacituzumab govitecan-hziy) compared to docetaxel in patients with previously treated metastatic non-small cell lung cancer (NSCLC). The findings, also published in the Journal of Clinical Oncology, revealed that the study did not achieve its primary endpoint of overall survival (OS).

The EVOKE-01 trial involved patients with metastatic or advanced NSCLC that had progressed after platinum-based chemotherapy and anti-PD-(L)1 therapy. Results indicated a 16% reduction in the risk of death for those treated with Trodelvy compared to docetaxel (median OS: 11.1 vs. 9.8 months; HR: 0.84). However, this improvement did not reach statistical significance. Notably, a subgroup of patients whose tumors did not respond to the last anti-PD-(L)1-containing treatment showed a meaningful OS improvement of 3.5 months with Trodelvy (median OS: 11.8 vs. 8.3 months; HR: 0.75).

For patients whose NSCLC had responded to the last anti-PD-(L)1 therapy, the median OS was similar between Trodelvy and docetaxel (9.6 vs. 10.6 months). More patients treated with Trodelvy survived at 12 months compared to those on docetaxel (46.6% vs. 36.7%).

Regarding safety, adverse events (AEs) of grade 3 or higher were lower in the Trodelvy group (66.6%) compared to the docetaxel group (75.7%). Fewer patients discontinued treatment due to AEs with Trodelvy (9.8% vs. 16.7%). The most common AEs for Trodelvy included fatigue, diarrhea, and alopecia, while for docetaxel, the prevalent AEs were fatigue, neutropenia, and diarrhea. Patients on docetaxel experienced higher rates of neutropenia, whereas those on Trodelvy had more cases of diarrhea.

Dr. Luis Paz-Ares, Head of Medical Oncology at Hospital Universitario 12 de Octubre in Madrid, emphasized the challenging nature of treating metastatic NSCLC post-progression. He highlighted the encouraging data from the Trodelvy subgroup, which warrants further investigation. Merdad Parsey, Chief Medical Officer at Gilead Sciences, expressed optimism about Trodelvy's potential impact and thanked those involved in the research.

In addition to the EVOKE-01 findings, Gilead will present further lung cancer research at the 2024 ASCO Annual Meeting, including results from the Phase 2 EVOKE-02 study. This study evaluated Trodelvy in combination with KEYTRUDA® (pembrolizumab) in first-line metastatic PD-L1 ≥50% NSCLC, showing a promising median progression-free survival (PFS) of 13.1 months. These results support the ongoing Phase 3 EVOKE-03 study in PD-L1-high metastatic NSCLC.

Trodelvy, a Trop-2-directed antibody-drug conjugate (ADC), is already approved for certain types of metastatic breast and urothelial cancers but remains investigational for metastatic NSCLC. The EVOKE-01 study enrolled 603 participants and focused on overall survival as the primary endpoint, with secondary endpoints including progression-free survival, objective response rate, and safety.

Gilead Sciences is dedicated to advancing innovative treatments for life-threatening diseases, including cancer. Their ongoing research in metastatic NSCLC with Trodelvy and other investigational drugs like domvanalimab and zimberelimab aims to address the significant unmet needs in lung cancer treatment.

This study's results, although not meeting the primary endpoint, reveal important insights into the potential benefits and safety of Trodelvy in treating metastatic NSCLC, highlighting the need for continued research and development in this challenging medical area.