Jemperli nears final hurdle for reimb in endometrial cancer

Cancer immunotherapy for endometrial cancer

Completes drug pricing negotiations with the NHIS

New treatment option for recurrent/advanced patients

The immunotherapy Jemperli is on the verge of securing expanded reimbursement coverage for endometrial cancer in Korea.

 

According to industry sources, GSK Korea has recently finalized drug price negotiations with the National Health Insurance Service (NHIS) for the PD-1 inhibitor Jemperli (dostarlimab).

 

The only step remaining is review by the Health Insurance Policy Deliberation Committee.

 

Specifically, the indication for reimbursement is extended to the treatment of newly diagnosed recurrent or advanced high microsatellite instability (MSI-H)/mismatch repair-deficient (dMMR) endometrial cancer.

 

Currently, the first-line standard of care for endometrial cancer is platinum-based chemotherapy combining paclitaxel and carboplatin.

 

However, one in four patients relapses or progresses after this therapy.

 

With the number of recurrent/advanced cases increasing but effective options lacking, the 5-year survival rate remains under 20%.

 

Jemperli was first listed for reimbursement in December 2023 as a second-line treatment for recurrent/advanced (FIGO stage IIIB and above) endometrial cancer that had progressed during or after platinum-based chemotherapy.

 

Since then, efforts have been made to add a first-line indication and expand reimbursement.

 

The drug’s efficacy in the first-line setting was confirmed through the Phase III RUBY trial.

 

The RUBY trial enrolled 494 patients with advanced or recurrent endometrial cancer, comparing Jemperli plus platinum-based chemotherapy (carboplatin + paclitaxel) against placebo plus chemotherapy.

 

Designed with more than 3 years of treatment follow-up—given that the average survival under standard platinum therapy is less than 3 years—the primary endpoints were progression-free survival (PFS) and overall survival (OS) per RECIST (Response Evaluation Criteria in Solid Tumors).

 

Results showed that the Jemperli combination reduced the risk of death by 31% versus the control group across the overall advanced/recurrent patient population.

 

Over a median follow-up of 37 months, the median OS in the Jemperli arm was 44.6 months, compared to 28.2 months in the control arm, extending survival by 16.4 months and lowering the risk of death by 31%.

 

Jae Kwan Lee from the Department of Obstetrics & Gynecology at Korea University Guro Hospital, said, “Endometrial cancer carries a high risk of recurrence even after initial treatment, so effective first-line options are crucial.

 

The RUBY trial is recognized as a landmark study that demonstrated the long-term efficacy of immunotherapy in this setting.” He added, “Jemperli in combination with platinum chemotherapy is the only immunotherapy available in Korea to show an OS benefit in endometrial cancer.

 

Importantly, the trial included high-risk groups, such as patients relapsing more than 6 months after chemotherapy and those with carcinosarcoma, yet still demonstrated significant clinical value.”