GSK’s Jemperli can now be used as a first-line treatment for all adult endometrial cancer patients following an expanded label approval in the US.
The FDA approved the PD-1 antibody in combination with the chemotherapies carboplatin and paclitaxel, followed by Jemperli monotherapy, in adult patients with primary advanced or recurrent endometrial cancer, including those with mismatch repair proficient (MMRp) and microsatellite stable (MSS) tumors. Those with that subset of tumors represent the bulk — 70% to 75% — of patients with endometrial cancer.
Jemperli was approved last year in the first-line treatment for those with mismatch repair deficient (dMMR) and microsatellite instability-high (MSI-H) patients, which is about 20% to 29% of all endometrial cancers. It is also in the market in the second-line setting.
Hesham AbdullahJemperli plus chemotherapy is so far the “first and only” immuno-oncology treatment to show a significant and meaningful improvement in overall survival in first-line patients, according to Hesham Abdullah, GSK’s global head of oncology R&D. For the past 15 to 20 years, chemotherapy has been the mainstay of treatment, he added.
“We haven’t really necessarily seen any new therapies emerge into the landscape until more recently and I would say [Jemperli] was probably the first to emerge in that space and more specifically in the dMMR and MSI high segment,” Abdullah told Endpoints News. “I think being able to hopefully provide patients with a treatment option that, for the first time in the past 15 to 20 years, that improves survival is something that’s quite important.”
The FDA based its new approval on progression-free survival and overall survival data from the first part of the RUBY Phase III trial, which showed a 31% reduction in risk of death compared to chemotherapy alone, and a 16.4-month improvement in median overall survival with Jemperli. Additional data in Jemperli’s favor included follow-up statistics after two and a half years: 61% of patients in the Jemperli combo group were alive compared to 49% of patients just taking chemotherapy.
GSK made £141 million on Jemperli last year, according to the company’s annual report, and £80 million in the first quarter of this year. GSK expects big revenues from the cancer drug and to eventually be a blockbuster by bringing in $1 billion to $2 billion per year at its peak.