Regulatory Decision Summary for Jemperli

This Supplement to a New Drug Submission (SNDS) was filed to obtain market authorization in accordance with section C.08.004 of the Food and Drug Regulations for Jemperli submitted by GlaxoSmithKline Inc. for a new indication: in combination with carboplatin and paclitaxel for the treatment of adult patients with primary advanced or recurrent endometrial cancer who are candidates for systemic therapy.

This is an expansion for the currently authorized indication of Jemperli in combination with carboplatin and paclitaxel for the treatment of adult patients with primary advanced or recurrent mismatch repair deficient (dMMR)/microsatellite instability-high (MSI-H) endometrial cancer who are candidates for systemic therapy to include adult patients with primary advanced or recurrent mismatch repair proficient (MMRp)/microsatellite stable (MSS) endometrial cancer (EC).

No changes are proposed for the dosage regimen. The same dosage regimen will be used for patients with MMRp/MSS EC as that currently authorised for patients with dMMR/MSI-H EC.

The sponsor consented to information sharing between Health Canada and health technology assessment organizations as part of an aligned review pathway.

RUBY study demonstrated a statistically significant improvement in progression free survival (PFS) with dostarlimab plus carboplatin + paclitaxel (carbo/pac), as compared to placebo plus carbo/pac, in adult patients with primary advanced or first recurrent EC (HR = 0.64, 95% CI: [0.51, 0.80], p < 0.0001) and the dMMR/MSI-H subpopulation (HR = 0.29, 95% CI: [0.17, 0.50]; p < 0.0001). In addition, RUBY study demonstrated a statistically significant improvement in overall survival (OS) with dostarlimab plus carbo/pac, as compared to placebo plus carbo/pac, in adult patients with primary advanced or first recurrent EC (HR = 0.69, 95% CI: [0.54, 0.89], p = 0.0020). An improvement of 16.4 months in the median OS (44.6 vs. 28.2 months) was observed, which is considered clinically meaningful. Differences in treatment effects in OS were observed in the dMMR/MSI-H subpopulation (HR = 0.34, 95% CI: [0.18, 0.62]) and the MMR proficient (MMRp)/microsatellite stable (MSS) subpopulation (HR = 0.82, 95% CI: [0.62, 1.08]). To ensure an informed use, these data are labelled in the product monograph (PM).

The safety results of dostarlimab plus carbo/pac observed in the RUBY study was consistent with the safety profiles of dostarlimab, carboplatin and paclitaxel, respectively, and is considered manageable. The key safety results are adequately labelled in the PM. The risk mitigation strategies for Jemperli are considered adequate.

Overall, the benefit-risk profile is favourable for Jemperli 50mg/mL for the following indication when used under the conditions of use recommended in the approved Product Monograph:

Jemperli is indicated in combination with carboplatin and paclitaxel for the treatment of adult patients with primary advanced or first recurrent endometrial cancer who are candidates for systemic therapy.

Therefore, a Notice of Compliance (NOC) was recommended.

An updated Risk Management Plan (RMP) for Jemperli was reviewed by Health Canada and considered acceptable.

Following review and requested revisions, the final labelling and Product Monograph were considered acceptable.

For further details about Jemperli, please refer to the Product Monograph, approved by Health Canada and available through the Drug Product Database.