PERLA is the largest global head-to-head trial of PD-1 inhibitors in this patient population
Confirmed objective response rate was 46% in patients treated with investigational dostarlimab combination versus 37% in the pembrolizumab combination
Key secondary endpoint of median progression-free survival was 8.8 months in the dostarlimab treatment arm versus 6.7 months in the pembrolizumab treatment arm
GSK plc (LSE/NYSE: GSK) today announced results from the PERLA phase II clinical trial investigating dostarlimab in combination with chemotherapy versus pembrolizumab in combination with chemotherapy as a first-line treatment for patients with metastatic non-squamous non-small cell lung cancer (NSCLC). Dostarlimab plus chemotherapy achieved very promising results for the primary endpoint of confirmed objective response rate (ORR) as well as for the key secondary endpoint of median progression-free survival (mPFS).

The PERLA phase II trial is a randomised, double-blind trial of 243 patients and is the largest global head-to-head trial of programmed death receptor-1 (PD-1) inhibitors in this patient population. The findings from the primary analysis were presented today at the European Society for Medical Oncology (ESMO) Immuno-Oncology Congress 2022 in Geneva, Switzerland.

Hesham Abdullah, Senior Vice President, Global Head of Oncology Development, GSK said: “The head-to-head data from the PERLA trial showed that dostarlimab combined with chemotherapy provided robust anti-tumour activity in patients with previously untreated metastatic non-squamous non-small cell lung cancer. The positive results from this trial inform our future development plans and highlight the potential for dostarlimab to be our foundational immuno-oncology therapy as a single-agent and in combination with standards of care and novel therapies within our pipeline.”

The primary endpoint was overall ORR by Response Evaluation Criteria in Solid Tumours (RECIST) as determined by blinded independent central review (BICR) and was 46% (n=56/121) in the dostarlimab treatment arm versus 37% (n=45/122) in the pembrolizumab treatment arm (difference in ORR: 9.32%; 80% CI: 1.46% to 17.18%).

The key secondary endpoint, mPFS, was 8.8 months (95% CI: 6.7 to 10.4) in the dostarlimab treatment arm versus 6.7 months (95% CI: 4.9 to 7.1) in the pembrolizumab treatment arm (HR 0.70 [95% CI: 0.50 to 0.98]).

The table below summarizes key results across all pre-specified programmed death ligand-1 (PD-L1) expression cohorts, as measured by Tumor Proportion Score (TPS).

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