GSK has eye on all-comers after latest endometrial cancer data for Jemperli

2024-03-18

临床结果并购临床3期上市批准ASCO会议

GSK said that a regimen of Jemperli (dostarlimab) plus standard chemotherapy reduced the risk of death by 31% versus chemotherapy alone in adults with primary advanced or recurrent endometrial cancer, boosting hopes of expanding the drug’s current label. The company also released new progression-free survival (PFS) data on the PD-1-blocking antibody in combination with the PARP inhibitor Zejula (niraparib).

“The results we’ve seen to date comprise the growing body of evidence supporting the role of [Jemperli] as the backbone of our immuno-oncology development programme,” remarked Hesham Abdullah, GSK's global head of oncology R&D.

Jemperli gained approval last year in the US and Europe for front-line treatment of advanced or recurrent endometrial cancer that is mismatch repair

deficient (dMMR) or microsatellite instability-high (MSI-H) based on positive PFS data from Part 1 of the Phase III RUBY trial. The first part of the study also achieved its overall survival (OS) endpoint.

Data unveiled on Saturday at the Society of Gynecologic Oncology (SGO) annual meeting on women’s cancer showed that median OS was 44.6 months for Jemperli plus chemotherapy, or 16.4 months longer than for chemotherapy alone. GSK added that in a subgroup of patients with mismatch repair proficient (MMRp)/microsatellite stable (MSS) tumours, Jemperli plus chemotherapy reduced the risk of death by 21%, with median OS in the two arms of 34 months and 27 months, respectively.

Meanwhile, Part 2 of the RUBY trial - which is investigating Jemperli plus chemotherapy followed by Jemperli plus Zejula, versus chemotherapy plus placebo followed by placebo – also hit its PFS goal, according to results top-lined last December.

Findings presented at the SGO conference showed that the Jemperli/Zejula arm had a 40% lower risk of disease progression or death, with median PFS of 14.5 months, or 6.2 months longer than the comparator group. In the MMRp/MSS population, the Jemperli/Zejula regimen reduced the risk of disease progression or death by 37%, with median PFS of 14.3 months, versus 8.3 months for chemotherapy alone.