AnaptysBio- and GSK-partnered immuno-oncology agent JEMPERLI (dostarlimab-gxly) meets primary endpoint in Phase 3 RUBY trial in primary advanced or recurrent endometrial cancer
- Pivotal Phase 3 (Part 1) trial demonstrates JEMPERLI plus chemotherapy significantly improved PFS versus chemotherapy plus placebo in patients with primary advanced or recurrent endometrial cancer
- First-in-class pivotal data in endometrial cancer, if approved, to be a potential significant driver of JEMPERLI royalties to
While the overall survival (OS) data were immature at the time of this analysis, a favorable trend was observed in the overall population, including both the dMMR/MSI-H and MMRp/MSS subgroups.
The safety and tolerability profile of dostarlimab plus chemotherapy was consistent with clinical trials of similar regimens.
Regulatory submissions based on the trial results are anticipated in the first half of 2023. GSK expects to publish full results from the RUBY trial in a medical journal and present at an upcoming scientific meeting.
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RUBY is a two-part global, randomised, double-blind, multicentre study of patients with primary advanced or recurrent endometrial cancer. Part 1 is evaluating dostarlimab plus carboplatin-paclitaxel followed by dostarlimab versus placebo plus carboplatin-paclitaxel followed by placebo. Part 2 is evaluating dostarlimab plus carboplatin-paclitaxel followed by dostarlimab plus niraparib versus placebo plus carboplatin-paclitaxel followed by placebo. The primary endpoints are progression-free survival (PFS), per RECIST v1.1 by investigator assessment, and overall survival in Part 1, and PFS in Part 2. Secondary endpoints include PFS per blinded independent central review (BICR), overall response rate, duration of response, disease control rate, patient-reported outcomes, and safety and tolerability. RUBY is part of an international collaboration of European Network of Gynaecological Oncological Trial groups (ENGOT) and the
About JEMPERLI (dostarlimab-gxly)
JEMPERLI is a programmed death receptor-1 (PD-1)-blocking antibody that binds to the PD-1 receptor and blocks its interaction with the PD-1 ligands PD-L1 and PD-L2. JEMPERLI is being investigated in registrational enabling studies, as monotherapy and as part of combination regimens, including in women with recurrent or primary advanced endometrial cancer, women with stage III or IV non-mucinous epithelial ovarian cancer, and in patients with other advanced solid tumours or metastatic cancers.
JEMPERLI is indicated in the US for adult patients with dMMR recurrent or advanced endometrial cancer, as determined by an FDA-approved test, that have progressed on or following prior treatment with a platinum-containing regimen. JEMPERLI is also indicated in the US for dMMR recurrent or advanced solid tumours, as determined by an FDA-approved test, that have progressed on or following prior treatment and who have no satisfactory alternative treatment options. These indications are approved in the US under accelerated approval based on tumour response rate and durability of response. Continued approval for these indications may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). In the EU, JEMPERLI received conditional approval for adult patients with dMMR/MSI-H recurrent or advanced endometrial cancer who have progressed on or following prior treatment with a platinum-containing regimen.
Source: AnaptysBio, Inc.