GSK advances combination PD-1 therapy into late-stage trials
GSK received US Food and Drug Administration (FDA) approval for Jemperli in April 2022, when it became the seventh PD-1/PD-L1 treatment to enter the US market.
Following the first approval in endometrial cancer, the treatment also received an accelerated approval for adult patients with mismatch repair-deficient recurrent or advanced solid tumors in August 2021.
In its latest trial, Jemperli was tested head-to-head against the market-leader in the area, Merck’s Keytruda (pembrolizumab). The PD-1 therapies were both tested in combination with chemotherapy in first-line patients with metastatic non-squamous non-small cell lung cancer (NSCLC).
The trial was set up to test non-inferiority to Keytruda in a Phase II trial and GSK announced that the Jemperli had successfully cleared the hurdle. In terms of further data on meeting the primary endpoint of overall response rate and secondary endpoint of progression-free survival, the company stated that it would release the information at an upcoming scientific meeting.
Keytruda was first approved all the way back in 2014 for advanced melanoma, since then the treatment has gone onto become one of the highest selling treatments in the industry. In the first quarter of this year, the treatment brought in revenue of $4.7bn (€4.76bn) for Merck and is the dominant treatment within the PD-1/PD-L1 area – making non-inferiority against Keytruda an important barrier to overcome for GSK’s treatment.
Finding an edge
Having emerged on the market later than rival treatments, GSK will be looking to discover potential advantages of its treatment against Keytruda and other established treatments to carve out its own portion of market share.
In order to do this, the company announced that Jemperli would be entering Phase III trials for the treatment of advanced NSCLC, where the treatment is being explored alongside cobolimab, a TIM-3 antagonist.
The combination therapy had already passed through Phase II/III trials, where an independent data monitoring committee recommending that the trial be expanded, after meeting its pre-specified expansion criteria per protocol.
This trial will test the combination therapy against Jemperli with chemotherapy and against chemotherapy alone. Participants in the trial will be those whose cancer has progressed despite prior anti-PD-L1 therapy and chemotherapy.
Hesham Abdullah, global head of oncology development at GSK, 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.”
Both Jemperli and cobolimab were acquired by GSK through its US$5.1bn acquisition of Tesaro in 2019.