AnaptysBio- and GSK-Partnered Immuno-Oncology Agent JEMPERLI (dostarlimab-gxly) plus Chemotherapy Approved in the U.S. for dMMR/MSI-H Primary Advanced or Recurrent Endometrial Cancer
- JEMPERLI is the first immuno-oncology treatment approved in the frontline setting for this patient population in combination with chemotherapy
U.S. Food and Drug Administrationapproval represents a potential significant driver of JEMPERLI royalties
- Anticipate top-line data from two GSK Phase 3 studies that include JEMPERLI to read out in 2024: the FIRST study in first-line ovarian cancer (H1 2024) and the COSTAR study in second-line NSCLC (H2 2024)
This approval is supported by interim analysis results from Part 1 of GSK’s Phase 3 RUBY trial. The dual-primary endpoints in Part 1 are investigator-assessed progression-free survival (PFS) and overall survival (OS). The statistical analysis plan included pre-specified analyses of PFS in the dMMR/MSI-H and intent-to-treat (ITT) populations and OS in the overall population. Part 1 of the RUBY trial continues to assess the dual-primary endpoint of OS in the ITT population.
“We are excited that JEMPERLI plus chemotherapy has been FDA-approved as the first new frontline treatment option in decades for patients with dMMR/MSI-H primary advanced or recurrent endometrial cancer,” said
JEMPERLI was discovered by
The sBLA supporting this new indication was reviewed under the
RUBY is a two-part global, randomized, double-blind, multicenter Phase 3 trial of patients with primary advanced or recurrent endometrial cancer. Part 1 is evaluating dostarlimab plus carboplatin-paclitaxel followed by dostarlimab versus carboplatin-paclitaxel plus placebo 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 dual-primary endpoints in Part 1 are investigator-assessed PFS based on the Response Evaluation Criteria in Solid Tumors v1.1 and OS. The statistical analysis plan included pre-specified analyses of PFS in the dMMR/MSI-H and ITT populations and OS in the overall population. Pre-specified exploratory analyses of PFS in the mismatch repair proficient (MMRp)/microsatellite stable (MSS) population and OS in the dMMR/MSI-H populations were also performed. RUBY Part 1 included a broad population, including histologies often excluded from clinical trials and had approximately 10% of patients with carcinosarcoma and 20% with serous carcinoma. In Part 2, the primary endpoint is investigator-assessed PFS. Secondary endpoints in Part 1 and Part 2 include PFS per blinded independent central review, overall response rate, duration of response, disease control rate, patient-reported outcomes, and safety and tolerability.
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 tumors or metastatic cancers.
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Source: AnaptysBio, Inc.