GSK has reported positive headline data from the Phase II PERLA clinical trial of Jemperli (dostarlimab) plus chemotherapy in first-line, metastatic, non-squamous non-small cell lung cancer (NSCLC) patients.
The randomised, international, double-blind trial assessed the safety and efficacy of dostarlimab plus chemotherapy versus pembrolizumab plus chemotherapy in 243 subjects.
Objective response rate (ORR) as evaluated by a blinded independent central review per Response Evaluation Criteria in Solid Tumours (RECIST) v1.1 was the primary endpoint of the trial.
Investigator-evaluated progression-free survival (PFS) per RECIST v1.1, safety, and overall survival comprised the trial’s secondary endpoints.
According to the findings, the trial met the primary endpoint of ORR.
Dostarlimab’s safety and tolerability profile in the trial was found to be in line with prior studies that assessed similar regimens.
Anaemia, nausea, asthenia, constipation, and neutropenia, among others, were reported to be the most prevalent treatment-emergent adverse reactions in the trial.
A programmed death receptor-1 (PD-1)-blocking antibody, Jemperli attaches to the PD-1 receptor and hinders its interaction with PD-L1 and PD-L2, which are the PD-1 ligands.
Apart from PERLA, the company is also progressing both arms of the COSTAR Lung trial into Phase III.
The move comes after the Independent Data Monitoring Committee recommended advancing the trial as it met its protocol-based expansion criteria.
The Phase III COSTAR Lung trial is assessing cobolimab plus dostarlimab and docetaxel versus dostarlimab, plus docetaxel versus docetaxel alone in advanced NSCLC patients.
GSK Oncology Development global head, senior vice-president Hesham Abdullah said: “These trials support the ambition for dostarlimab to become the backbone of our ongoing immuno-oncology-based research and development programme when used alone and in combination with standard of care and future novel cancer therapies, particularly in patients with currently limited treatment options.”
In September this year, the company reported data from the Phase III PRIMA trial where Zejula (niraparib) offered a lasting PFS benefit in ovarian cancer patients.