Adding Jemperli to Chemo Lengthens Time to Progression in Early Endometrial Cancer

Patient-reported outcomes were similar between patients who received the combination versus those who received carboplatin/paclitaxel plus placebo after three years of treatment.

Adding Jemperli (dostarlimab-gxly) to carboplatin/paclitaxel improved survival and maintained quality of life in patients with primary advanced or recurrent endometrial cancer, according to findings from a phase 3 trial.

Findings from the phase 3 ENGOT-EN6/GOG3031/RUBY trial were reported at the 2023 American Society of Clinical Oncology Meeting.

Patient-reported outcomes were similar between patients who received the combination versus those who received carboplatin/paclitaxel plus placebo after three years of treatment. Measurements were collected at baseline, on day 1 of each treatment cycle and at the end of treatment. Several scales were assessed regarding quality of life including global pain, fatigue and physical function.

Among patients withmismatch repair deficient (cells with many mutations that may lead to cancer)/microsatellite instability–high (cancer cells with high number of mutations within microsatellites that prevents them from correcting mistakes that occur within DNA) disease who received Jemperli plus carboplatin/paclitaxel, improvements from the start of the study were observed at cycle 7 in global health score/quality of life, physical functioning, role functioning, pain, and back/pelvis pain. When compared with the improvements in the placebo plus carboplatin/paclitaxel arm, these improvements were deemed nominally significant.

In the overall population, no differences were reported across these symptom scales between the two arms at cycle 7 or 13.

“(Jemperli) plus (carboplatin/paclitaxel) significantly improved (progression-free survival) while maintaining (health-related quality of life) in both the (mismatch repair deficient)/(microsatellite instability–high) and overall populations,” Dr. Mansoor Raza Mirza, chief oncologist in the department of oncology in Rigshospitalet, Copenhagen University Hospital, Denmark, said in a presentation of the findings.

Previous reports from the randomized RUBY trial showed that Jemperli plus carboplatin/paclitaxel doubled the two-year progression-free survival (the time during and after treatment when a patient with cancer lives with the disease without worsening) rate at 36.1% compared with 18.1% with placebo plus carboplatin/paclitaxel. Moreover, although overall survival (the time when a patient with cancer is still alive) data are not mature (meaning that there hasn’t been enough time or the number of events to accurately measure this outcome), there is a clinically meaningful trend towards improved overall survival, according to investigators.

Though they hypothesize that this treatment regimen will improve outcomes for this patient population, patient-reported outcome assessments are an important variable in assessing how this treatment benefits patients, as monitoring patient-reported outcomes allows investigators to better understand and potentially improve patient health-related quality of life.

The RUBY trial enrolled 494 patients with primary advanced or recurrent endometrial cancer. These patients were randomly assigned to receive either Jemperli plus carboplatin/paclitaxel or placebo plus carboplatin/paclitaxel, followed by either Jemperli or placebo monotherapy for up to three years or until disease progression.

Researchers focused on several outcomes including progression-free survival, overall survival, time to second disease progression, duration of response, disease control rate, safety and health-related quality of life.

Mirza noted that when interpreting these patient-reported outcome measures it is important to bear in mind that higher scores indicate better health-related quality of life and better functioning in terms of quality of life/functional scales, and that higher scores indicate worse symptoms when assessing domains such as pain, muscular pain, and hair loss.

At cycle 7, there were no significant differences between theJemperli and placebo arms in the mismatch repair deficient/microsatellite instability–high population in terms of mean change in fatigue. In the overall population, no significant differences were reported at cycle 7 in terms of pain, fatigue, or back/pelvis pain between the experimental and control arms.

Also at cycle 7, no significant differences were reported in the mismatch repair deficient/ microsatellite instability–high cohorts for a mean change in emotional, cognitive and social functioning. In the overall population, no significant differences were reported at cycle 7 for a mean change in quality of life nor physical, role, emotional, cognitive or social functioning.

No significant differences between Jemperli and placebo were reported at cycle 13 in the mismatch repair deficient/microsatellite instability–high cohorts for a mean change in baseline in pain, fatigue, or back and pelvis pain. This finding was consistent in the overall population.

Similarly, no significant differences between Jemperli and placebo were reported at cycle 13 in either the mismatch repair deficient/microsatellite instability–high or overall populations for global health scores, physical functioning, role functioning, emotional functioning, cognitive functioning or social functioning.

“These results further support the use of (Jemperli) plus (carboplatin/paclitaxel) as a standard of care in patients with primary advanced or recurrent endometrial cancer,” Mirza concluded.

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