KEY TAKEAWAYS
- The EVOKE-02 phase 2 trial aimed to analyze outcomes by histology in patients treated with SG + pembro.
- The primary endpoint was PFS.
- The results demonstrated promising activity and manageable safety of SG + pembrolizumab in previously untreated mNSCLC.
Sacituzumab govitecan (SG), an antibody-drug conjugate targeting Trop-2, has shown efficacy and tolerability in heavily treated metastatic non-small cell lung cancer (mNSCLC) patients. EVOKE-02 (NCT05186974) is a phase II trial investigating SG + pembrolizumab (pembro) with or without platinum-based therapy in first-line mNSCLC.
F. Cappuzzo and his team conducted a study that aimed to present outcomes based on histology (squamous vs. nonsquamous) in patients receiving SG + pembro in Cohorts A and B of EVOKE-02.
Age 18 years or older, untreated mNSCLC, non-functional genomic alterations, and ECOG PS 1 or lower, enrolled in group A (programmed death [ligand] 1 [PD-1]. L1] tumor proportion score [TPS].≥ 50%) ; or group B (PD-L1 TPS < 50%). PD-L1 status, if unknown, was determined locally or centrally by the 22C3 test before enrollment. Patients received SG 10 mg/kg on day 1 and day 8 plus Pembro 200 mg on day 1 of the 21-day cycle.
The primary endpoint was objective response rate (ORR; according to RECIST v1.1), with secondary endpoints including progression-free survival (PFS), overall survival (OS), duration of response (DOR), disease control rate (DCR), and safety.
About 30 patients were enrolled in Cohort A and 33 in Cohort B. In Cohort A (PD-L1 TPS ≥ 50%), the ORR, as assessed by investigators, was 73% (8/11) for efficacy-evaluable patients with squamous mNSCLC and 67% (12/18) (those with ≥ 13 weeks of follow-up) with nonsquamous mNSCLC; in Cohort B (PD-L1 TPS < 50%), it was 54% (7/13) and 37% (7/19), respectively.
Median DOR was not reached in either cohort. Among the safety population (N = 63), any-grade treatment-emergent adverse events (TEAEs) were reported in all patients (100%), with 70% being grade ≥ 3.
The analysis revealed encouraging efficacy of SG + pembro across histological subtypes in untreated mNSCLC, with a manageable safety profile consistent with each agent’s known profile.
The trial was sponsored by Gilead Sciences.
Clinical Trial: https://clinicaltrials.gov/study/NCT05186974
F. Cappuzzo, J. Patel, B.C. Cho, et al. (2024) “Sacituzumab govitecan (SG) + pembrolizumab (pembro) in first-line (1L) metastatic non-small cell lung cancer (mNSCLC): Efficacy results by histology from the EVOKE-02 study.” Presented at ELCC 2024. Annals of Oncology (2024) 9 (suppl_3): 1-53. 10.1016/esmoop/esmoop102569 (60P).
