Positive headline Phase II trial results of Jemperli set scene for Phase III

The PERLA Phase II trial of cancer drug Jemperli (dostarlimab) met its primary endpoint of objective response rate (ORR) by Response Evaluation Criteria in Solid Tumors (RECIST) criteria as determined by blinded independent central review, says UK pharma major GSK (LSE:GSK), which is a late comer to the PD-/PD-Li inhibitors sector.

The study assessed dostarlimab in combination with chemotherapy versus pembrolizumab (Merck & Co’s [NYSE: MRK] mega blockbuster Keytruda) in combination with chemotherapy in first-line patients with metastatic non-squamous non-small cell lung cancer (NSCLC). The PERLA Phase II trial is a randomized, 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 population. The trial was not designed to demonstrate superiority, but the drug was shown to be as effective as its rival.

Jemperli was acquired by GSK as part of its $5.1 billion takeover of Tesaro in 2019, but has not yet made significant sales. The company has predicted that Jemperli will eventually make blockbuster sales, and has a peak sales forecast of £1 to £2 billion ($1.14-$2.28 billion) for the drug, a range that some analysts view as optimistic. First-half 2020 sales were just £8 million.