GSK plans to file for approval of Jemperli in endometrial cancer after the checkpoint inhibitor met its primary endpoint in the Phase III RUBY trial, the company announced Friday.
Based on the strength of the interim analysis, GSK said it intends to seek regulatory approval in the first half of 2023. Full data from the RUBY study will be presented at a later date.
A GSK spokesperson told BioSpace that if approved, based on this data, Jemperli has the potential to become the first anti-PD-1 plus platinum-based chemotherapy treatment combination approved in primary advanced or recurrent endometrial cancer.
Additionally, the spokesperson stressed the RUBY data is the only trial that shows show improvement in progression-free survival for an immuno-oncology therapy in combination with standard-of-care chemotherapy in this indication.
Data showed Jemperli (dostarlimab) combined with chemotherapy generated a statistically significant and clinically meaningful improvement in investigator-assessed progression-free survival (PFS) in patients with primary advanced or recurrent endometrial cancer. The combination was assessed as a first-line treatment for these patients.
When GSK conducted the interim analysis, the company stated the combination of Jemperli and chemotherapy generated a significant and clinically meaningful benefit in the “prespecified mismatch repair deficient (dMMR)/microsatellite instability-high (MSI-H) patient subgroup,” as well as in the overall population.
The overall survival data from the RUBY was immature at the time of the analysis. But, the company noted this morning that a favorable trend was observed in the overall population and in the subgroups of patients.
In 2021, the FDA approved Jemperli for patients with dMMR recurrent or advanced endometrial cancer. The regulatory agency also granted accelerated approval to Jemperli for the treatment of adult patients with dMMR recurrent or advanced solid tumors.
A Multi-Faceted Therapeutic
Other indications could be on the horizon for Jemperli. Last month, GSK presented data showing Jemperli generated positive results as a first-line treatment for non-small cell lung cancer in the Phase II PERLA trial.
Also this year, treatment with Jemperli sent 12 rectal cancer patients into complete remission. In that small study, Jemperli was assessed as a first-line treatment for MMRd locally advanced rectal cancer. As BioSpace reported at the time, the data was so positive it was considered “unheard of.”
In the RUBY study, Jemperli continued to maintain a consistent safety and tolerability profile. The most common treatment-related adverse events were nausea, alopecia, fatigue, peripheral neuropathy, anemia, arthralgia, constipation and diarrhea.
For GSK, the good news from the RUBY study follows its decision to pull its multiple myeloma drug Blenrep from the U.S. market at the request of the FDA following its failure in a confirmatory study. BioSpace reported that Blenrep failed to “induce significantly superior progression-free survival” in patients with relapsed or refractory multiple myeloma, compared to pomalidomide and low-dose dexamethasone.
GSK also restricted the use of its PARP inhibitor Zejula to a specific population as a second-line maintenance treatment for ovarian cancer following updated Phase III data. GSK gained both Zejula and Jemperli in its acquisition of Tesaro.
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