Dostarlimab or pembrolizumab plus chemotherapy in previously untreated metastatic non-squamous non-small cell lung cancer: the randomized PERLA phase II trial

Sun Min Lim (), Solange Peters, Ana Laura Ortega Granados, Gustavo dix Junqueira Pinto, Christian Sebastián Fuentes, Giuseppe Lo Russo, Michael Schenker, Jin Seok Ahn, Martin Reck, Zsolt Szijgyarto, Neda Huseinovic, Eleftherios Zografos, Elena Buss, Neda Stjepanovic, Sean O’Donnell and Filippo Marinis
Additional contact information
Sun Min Lim: Yonsei University College of Medicine
Solange Peters: Lausanne University
Ana Laura Ortega Granados: Hospital Universitario de Jaén
Gustavo dix Junqueira Pinto: Barretos Cancer Hospital
Christian Sebastián Fuentes: FUNDACIÓN RESPIRAR
Giuseppe Lo Russo: Thoracic Unit, Fondazione IRCCS Istituto Nazionale dei Tumori
Michael Schenker: 23 Strada Caracal, Craiova, Județul Dolj, Romania, and the University of Medicine and Pharmacy
Jin Seok Ahn: Samsung Medical Center, Sungkyunkwan University
Martin Reck: Center for Lung Research
Zsolt Szijgyarto: GSK
Neda Huseinovic: GSK
Eleftherios Zografos: GSK
Elena Buss: GSK
Neda Stjepanovic: GSK
Sean O’Donnell: GSK
Filippo Marinis: Istituto Europeo di Oncologia (IRCCS)

Nature Communications, 2023, vol. 14, issue 1, 1-12

Abstract: Abstract PERLA is a global, double-blind, parallel phase II trial (NCT04581824) comparing efficacy and safety of anti–PD-1 antibodies dostarlimab and pembrolizumab, plus chemotherapy (DCT and PCT, respectively) as first-line treatment in patients with metastatic non-squamous NSCLC without known targetable genomic aberrations. Patients stratified by PD-L1 tumor proportion score and smoking status were randomized 1:1, receiving ≤35 cycles 500 mg dostarlimab or 200 mg pembrolizumab, ≤35 cycles 500 mg/m2 pemetrexed and ≤4 cycles cisplatin (75 mg/m2) or carboplatin (AUC 5 mg/ml/min) Q3W. Primary endpoint was overall response rate (ORR) (blinded independent central review). Secondary endpoints include progression-free survival (PFS) based on investigator assessment, overall survival (OS) and safety. Exploratory endpoints include ORR by PD-L1 subgroup and duration of response. PERLA met its pre-specified endpoint. ORR (n/N; 95% CI) is 45% (55/121; 36.4–54.8) for DCT and 39% (48/122; 30.6–48.6) for PCT (data cut-off: 07 July 23), numerically favoring dostarlimab in PD-L1-positive subgroups. Median PFS (months [95% CI]) is 8.8 (6.7–10.4) for DCT and 6.7 (4.9–7.1) for PCT (HR 0.70 [95% CI: 0.50–0.98]; data cut-off: 04 August 22). Median OS (months [95% CI]) is 19.4 (14.5–NR) for DCT and 15.9 (11.6–19.3) for PCT (HR 0.75 [95% CI: 0.53–1.05]) (data cut-off: 07 July 23). Safety profiles are similar between groups. In this study, DCT shows similar efficacy to PCT and demonstrates clinical efficacy as first-line treatment for patients with metastatic non-squamous NSCLC.

Date: 2023
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DOI: 10.1038/s41467-023-42900-4

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