JEMPERLI

What it is

JEMPERLI contains dostarlimab. Dostarlimab is an anti-programmed cell death protein-1 (PD-1) immunoglobulin G4 (IgG4) humanised monoclonal antibody. Each vial of 10 mL concentrate for solution for infusion contains 500 mg of dostarlimab (50 mg/mL). Dostarlimab is for intravenous infusion only and should be administered by intravenous infusion using an intravenous infusion pump over 30 minutes. This medicinal product is subject to additional monitoring in Australia to allow quick identification of new safety information.

Approved indications

— Treatment in combination with carboplatin and paclitaxel for adult patients with primary advanced or recurrent endometrial cancer. — Treatment as monotherapy for adult patients with recurrent or advanced mismatch repair deficient (dMMR) endometrial cancer that has progressed on or following prior treatment with a platinum-containing regimen.

Dosing overview

Dose reduction is not recommended. Dosing delay or discontinuation may be required based on individual safety and tolerability.

Key safety warnings

Immune-related adverse reactions, which may be severe or fatal, can occur in patients treated with PD-1/PD-L1 blocking antibodies, including dostarlimab. While immune-related adverse reactions usually occur during treatment, symptoms can also manifest after discontinuation of treatment. Patients should be monitored for symptoms and signs of immune-related adverse reactions. Haematological and clinical chemistries, including liver, kidney and thyroid function tests, should be evaluated at baseline and periodically during treatment. Pneumonitis has been reported in patients receiving dostarlimab. Patients should be monitored for signs and symptoms of pneumonitis. Suspected pneumonitis should be confirmed with radiographic imaging and other causes excluded. Dostarlimab can cause immune-related colitis. Patients should be monitored for signs and symptoms of colitis and managed with dostarlimab treatment modifications, anti-diarrhoeal agents and corticosteroids. Immune-related endocrinopathies, including hypothyroidism, hyperthyroidism, thyroiditis, hypophysitis, type 1 diabetes mellitus, diabetic ketoacidosis and adrenal insufficiency, have been reported in patients receiving dostarlimab. Patients should be monitored for abnormal thyroid function tests prior to and periodically during treatment. Dostarlimab can cause immune-related nephritis. Patients should be monitored for changes in renal function and managed with dostarlimab treatment modifications and corticosteroids. Stevens-Johnson Syndrome, toxic epidermal necrolysis or drug rash with eosinophilia and systemic symptoms have been reported in patients treated with PD-1 inhibitors. Caution should be used when considering the use of dostarlimab in a patient who has previously experienced a severe or life-threatening skin adverse reaction on prior treatment with other immune-stimulatory anticancer agents. Solid organ transplant rejection has been reported in patients treated with PD-1 inhibitors. Treatment with dostarlimab may increase the risk of rejection in solid organ transplant recipients. The benefit of treatment versus the risk of possible organ rejection should be considered in these patients. Dostarlimab can cause infusion-related reactions, which can be severe. For severe or life-threatening infusion-related reactions, stop infusion and permanently discontinue dostarlimab.

Contraindications

JEMPERLI is contraindicated in patients with a known hypersensitivity to dostarlimab or any of the excipients.

PBS listing

The 500 mg concentrate for solution for infusion in 10 mL vial is listed on the PBS with 4 items under streamlined restriction at an ex-manufacturer price of A$7647.50.

Regulatory history

JEMPERLI dostarlimab 500 mg concentrate for solution for infusion was first listed on the ARTG on 17 February 2022. JEMPERLI received provisional registration, with full registration depending on verification and description of clinical benefit in confirmatory trials. The provisional approval was based on objective response rate and duration of response observed in a single-arm trial. In March 2022, the PBAC did not recommend dostarlimab for recurrent or advanced mismatch repair deficient endometrial cancer that has progressed on or following prior treatment with a platinum-containing regimen. In November 2023, the PBAC recommended listing in combination with platinum-containing chemotherapy for primary advanced or first recurrent mismatch repair deficient endometrial cancer under Section 100 (Efficient Funding of Chemotherapy Program) as cost-effective with price reduction. In May 2025, the PBAC did not recommend dostarlimab in combination with platinum-containing chemotherapy for the treatment of primary advanced or first recurrent mismatch repair proficient endometrial cancer.