KEY TAKEAWAYS
- The phase II trial aimed to assess the impact of dostar combined with CT compared to pembro combined with CT on OS in metastatic NSCLC patients.
- The primary endpoint was ORR. The secondary endpoint was OS, while the exploratory endpoint was DOR.
- The result demonstrated that Dostar + CT remains effective in follow-up, suggesting a potential survival advantage without new safety concerns.
First global head-to-head trial of dostarlimab (dostar) vs. pembrolizumab (pembro) for non-small cell lung cancer(NSCLC) (PERLA trial). Dostar + chemotherapy(CT) showed equivalence to pembro + CT in response rate and progression-free survival(PFS) but hinted at a potential survival benefit.
For this study, researchers aimed to assess the impact of dostar combined with CT compared to pembro combined with CT on overall survival(OS) in metastatic NSCLC patients.
Patients with metastatic NSCLC confirmed PD-L1 status, absence of EGFR, ALK, or other actionable genomic aberrations determined locally, ECOG 0–1, and no prior systemic treatment were randomly assigned in a 1:1 ratio to receive dostar 500 mg or pembro 200 mg intravenously (IV) every 3 weeks (Q3W) for up to 35 cycles. Both groups received combination CT (4 cycles of pemetrexed [pem; 500 mg/m2] + carboplatin [AUC 5 mg/mL/min] or cisplatin [75 mg/m2], followed by pemetrexed up to 35 cycles) IV every 3 weeks.
The primary endpoint was the objective response rate (ORR) determined by a blinded independent central review (BICR). OS was a secondary endpoint, and the duration of response (DoR) by BICR was an exploratory endpoint. OS and DoR were assessed using the Kaplan-Meier method, with 95% CIs determined by the Brookmeyer-Crowley method and HR calculated by the stratified Cox proportional hazard model.
About 243 patients were randomized and treated, 121 in the dostar + CT arm and 122 in the pembro + CT arm.OS maturity was 55% (134/243). In the dostar + CT arm, the median OS was 19.4 months (95% CI 14.5, NR), while in the pembro + CT arm, it was 15.9 months (95% CI 11.6, 19.3). The median follow-up (IQR) was 20.7 months (17.3, 24.0) for dostar + CT and 21.6 months (18.3, 24.1) for pembro + CT. This trend was consistent across PD-L1 subgroups, and new safety signals were reported.
The result demonstrated that Dostar + CT remains effective in follow-up, suggesting a potential survival advantage without new safety concerns.
Clinical Trial: https://clinicaltrials.gov/study/NCT04581824
S. Peters, A.L.O. Ortega Granados, F. de Marinis, G. Lo Russo, M. Schenker, E. Arriola, J.M. Puig, D.H. Lee, M. Reck, Z. Szijgyarto, E. Buss, N. Stjepanovic, S.M. Lim. “Overall survival from a phase II randomized double-blind trial (PERLA) of dostarlimab (dostar) + chemotherapy (CT) vs pembrolizumab (pembro) + CT in metastatic non-squamous NSCLC.” Annals of Oncology (2023) 34 (suppl_2): S1254-S1335. DOI: 10.1016/annonc/annonc1358-
