Northwestern University Feinberg School of Medicine, Chicago, IL
Jyoti D. Patel , Byoung Chul Cho , Manuel Cobo , Roxana Reyes Cabanillas , David Vicente , Jose Fuentes Pradera , Edward B. Garon , Tony S. K. Mok , Federico Cappuzzo , Joel W. Neal , Sabeen Fatima Mekan , Farnoush Safavi , Nelumka Fernando , Michael Jon Chisamore , Martin Reck
Background: SG, a Trop-2–directed antibody-drug conjugate, has clinical activity and manageable safety in heavily pretreated patients with mNSCLC. EVOKE-02 (NCT05186974) is an ongoing, global, open-label, multicohort phase 2 study evaluating SG + pembro ± platinum agent as 1L treatment for mNSCLC. We report safety and efficacy results from Cohort A of EVOKE-02, with a median follow-up of 11.3 months. Methods: Patients aged ≥18 years with no prior systemic mNSCLC treatment, no actionable genomic alterations, and an ECOG performance status of 0 or 1 were enrolled into Cohort A [PD-(L)1 tumor proportion score ≥50%, 22C3 assay]. Patients received SG 10 mg/kg intravenously on days 1 and 8 + pembro 200 mg intravenously on day 1 of 21-day cycles. Primary endpoints include objective response rate (ORR; RECIST v1.1) per independent review committee (IRC); secondary endpoints include progression-free survival (PFS), duration of response (DOR), disease control rate (all per IRC), overall survival (OS), and safety. Results: As of December 1, 2023, 30 patients in Cohort A were enrolled and had received SG + pembro. Median age was 67 (range, 47-77) years; 60% had nonsquamous histology and 80% had an ECOG performance status of 1. Among all treated patients (n=30), ORR was 67% (95% CI, 47-83%) (squamous, 67% [95% CI, 35-90%]; nonsquamous, 67% [95% CI, 41-87%]). Median PFS was 13.1 (95% CI, 5.5-not reached [NR]) months (squamous, NR [95% CI, 1.2-NR] months; nonsquamous, 13.1 [95% CI, 5.5-NR] months). Median DOR was NR. In the safety population (n=30), the incidence of grade ≥3 treatment-emergent adverse events (TEAEs) and of grade ≥3 TEAEs related to any study drug were 67% and 40%, respectively. Grade ≥3 TEAEs in ≥10% of patients were neutropenia (17%), diarrhea (10%), and respiratory failure (10%). TEAEs leading to SG discontinuation occurred in 17%. There was 1 (3%) treatment-related death due to neutropenic sepsis. Conclusions: SG + pembro demonstrated promising activity in patients with tumor proportion score ≥50% mNSCLC. AEs were manageable and consistent with the known safety profile of each individual agent. The EVOKE-03 study (NCT05609968) of pembro vs SG + pembro in mNSCLC is ongoing. Clinical trial information: NCT05186974.
Overall (n=30) | Squamous (n=12) | Nonsquamous (n=18) | |
---|---|---|---|
ORR (CR+PR), n (% [95% CI]) | 20 (67 [47-83]) | 8 (67 [35-90]) | 12 (67 [41-87]) |
CR, n (%) | 1 (3) | 0 | 1 (6) |
PR, n (%) | 19 (63) | 8 (67) | 11 (61) |
SD, n (%) | 6 (20) | 2 (17) | 4 (22) |
PD, n (%) | 3 (10) | 2 (17) | 1 (6) |
Not evaluable, n (%) | 1 (3) | 0 | 1 (6) |
Median PFS, mo [95% CI] | 13.1 [5.5-NR] | NR [1.2-NR] | 13.1 [5.5-NR] |
DOR, mo [95% CI] | NR [8.5-NR] | NR [2.4-NR] | NR [4.6-NR] |
CR, complete response; PD, progressive disease; PR, partial response; SD, stable disease.
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