60P 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

SG, a Trop-2–directed antibody-drug conjugate, has demonstrated activity and manageable safety in heavily pretreated patients with mNSCLC. EVOKE-02 (NCT05186974) is an open-label, multicohort phase II study evaluating SG + pembro ± a platinum agent in 1L mNSCLC. Here we report results by histology (squamous vs nonsquamous) in patients treated with SG + pembro in Cohorts A and B of EVOKE-02. Patients aged ≥ 18 years, with no prior systemic treatment for mNSCLC, no actionable genomic alterations, and an ECOG PS of ≤ 1 were enrolled into Cohort A (programmed death ligand 1 PD-L1 tumor proportion score TPS ≥ 50%) or B (PD-L1 TPS < 50%). PD-L1 status, if not already known, was determined locally or at the central laboratory using the 22C3 assay prior to enrollment. Patients received SG 10 mg/kg on Days 1 and 8 + pembro 200 mg on Day 1 of a 21-day cycle. The primary end point is objective response rate (ORR; per RECIST v1.1); secondary end points include progression-free survival, overall survival, duration of response (DOR), disease control rate (DCR), and safety. As of June 16, 2023, 30 patients in Cohort A and 33 in Cohort B were enrolled. In Cohort A (PD-L1 TPS ≥ 50%), the ORR by investigator assessment was 73% (8/11) in efficacy-evaluable patients (those with ≥ 13 weeks of follow-up) with squamous mNSCLC and 67% (12/18) in patients with nonsquamous mNSCLC; in Cohort B (PD-L1 TPS < 50%), it was 54% (7/13) and 37% (7/19), respectively (Table). Median DOR was not reached in either cohort. In the safety population (N = 63), any-grade treatment-emergent adverse events (TEAEs) were reported in 63 patients (100%; grade ≥ 3, 70%).Table: 60PEfficacy by investigator assessmentSquamous mNSCLCNonsquamous mNSCLCCohort APD-L1 TPS≥ 50% (n = 11)Cohort BPD-L1 TPS< 50% (n = 13)Cohort APD-L1 TPS≥ 50% (n = 18)Cohort BPD-L1 TPS< 50% (n = 19)ORR,aIncludes confirmed and unconfirmed responses. n (%) 95% CI8 (73) 39-947 (54) 25-8112 (67) 41-877 (37) 16-62Best overall response,aIncludes confirmed and unconfirmed responses. n (%)PR8 (73)7 (54)12 (67)7 (37)Confirmed PR7 (64)6 (46)11 (61)6 (32)SD1 (9)4 (31)4 (22)7 (37)PD2 (18)01 (6)2 (11)Not assessed02 (15)1 (6)3 (16)DCR,bComplete response + PR + SD ≥ 6 weeks. n (%) 95% CI9 (82) 48-9811 (85) 55-9816 (89) 65-9914 (74) 49-91PD, progressive disease; PR, partial response; SD, stable disease.a Includes confirmed and unconfirmed responses.b Complete response + PR + SD ≥ 6 weeks. Open table in a new tab PD, progressive disease; PR, partial response; SD, stable disease. In EVOKE-02, SG + pembro showed promising activity regardless of histology (squamous and nonsquamous) in previously untreated mNSCLC. The safety profile was manageable and consistent with the known safety profile of each agent.