KEY TAKEAWAYS
- The phase 2 EVOKE-02 study evaluated the use of SG with pembro, with or without a platinum agent, as a first-line treatment for mNSCLC.
- The trial’s endpoints were ORR, PFS, DoR, DCR, OS, and safety.
- SG + pembro showed promising early efficacy and manageable safety in Cohorts A and B of previously untreated mNSCLC pts.
In the EVOKE-02 study, Cohorts A and B included adults with previously untreated metastatic non-small cell lung cancer (mNSCLC), no actionable genomic mutations, and an ECOG performance status of 0 or 1. Cohort A consisted of patients (pts) with a PD-L1 tumor proportion score (TPS) ≥50%, while Cohort B included pts with a PD-L1 TPS <50%. Patients in both cohorts receive sacituzumab govitecan (SG) at a 10 mg/kg dosage on Day 1 and 8, along with pembrolizumab (pembro) at 200 mg on Day 1, following a 21-day cycle.
The study evaluated various endpoints, including objective response rate (ORR) according to RECIST v1.1, progression-free survival, duration of response, disease control rate, overall survival, and safety. In this preliminary report, safety data are presented for pts who received at least one dose of the study treatment. At the same time, efficacy results are based on pts with a follow-up period of at least 13.0 weeks.
As of January 13, 2023, 44 pts (16 in Cohort A and 28 in Cohort B) have enrolled and been treated with SG + pembro. The median age was 68 years, with an age range of 47 to 80. Most patients (64%) had non-squamous histology, and 77% had an ECOG performance status of 1. Among pts evaluated for efficacy (8 in Cohort A and 18 in Cohort B), the ORR, as assessed by investigators, was 75% in Cohort A (including 5 confirmed partial responses and 1 pending confirmation) and 44% in Cohort B (including 7 confirmed partial responses and 1 pending confirmation).
In the group of pts evaluated for safety (44 in total), 96% experienced treatment-emergent adverse events (TEAEs) of any grade, with 52% being grade 3/4. The most common TEAEs included diarrhea (50%), anemia (41%), asthenia (36%), and neutropenia (32%). SG discontinuation due to TEAEs occurred in 7% of pts, and TEAEs leading to death were reported in 3 pts (7%), with only 1 case (2%) considered related to the study treatment.
In Cohorts A and B, the combination of SG + pembro demonstrated promising early efficacy while maintaining a manageable safety profile consistent with the available safety profiles of each individual agent. Further results with a larger patient population and longer follow-up will be presented in future analyses.
Source: https://cattendee.abstractsonline.com/meeting/10925/presentation/955
Clinical Trial: https://classic.clinicaltrials.gov/ct2/show/NCT05186974
Cho, B.C., Dols, M.C., Cabanillas, R.R., Baz, D.V., Pradera, J.F., Grisanti, S., Gabayan, A.E., Lee, K.H., Cho, E.K., Mekan, S., Safavi, F., Fernando, N., Chisamore, M.J., Reck, M. Sacituzumab Govitecan + Pembrolizumab in 1L Metastatic Non-Small Cell Lung Cancer: Preliminary Results of the EVOKE-02 Study.
