Jemperli

Endometrial cancer — mismatch repair deficient (dMMR) recurrent or advanced, as single agent after progression on or after prior platinum-containing regimen; Primary advanced or recurrent endometrial cancer — with carboplatin and paclitaxel, followed by single-agent dostarlimab (regardless of MMR status); dMMR recurrent or advanced solid tumors — as single agent after progression on or after prior treatment with no satisfactory alternative treatment options

dMMR endometrial/solid tumors (monotherapy): 500 mg IV every 3 weeks for 4 doses, then 1000 mg IV every 6 weeks until progression
Endometrial (with chemo): 500 mg IV every 3 weeks for 6 doses during chemo, then 1000 mg IV every 6 weeks as maintenance for up to 3 years
Infusion time: Over 30 minutes

Injection: 50 mg/mL solution in 10 mL (500 mg) single-dose vial

None listed.

• Immune-Mediated Adverse Reactions: Pneumonitis (2.4%), colitis (1.4%), hepatitis (0.5%), endocrinopathies (including hypothyroidism 7.5%, hyperthyroidism 1.7%, adrenal insufficiency 0.4%, hypophysitis 0.2%), nephritis (0.4%), dermatologic reactions (1.2%).
• Infusion-Related Reactions: In 2.7% of patients.
• Complications of Allogeneic HSCT
• Embryo-Fetal Toxicity

Fatigue/asthenia (42%), nausea (30%), diarrhea (26%), anemia (24%), constipation (18%), rash (14%), vomiting (14%), arthralgia (12%), pruritus (10%), hypothyroidism (7.5%)

Consult the complete prescribing information for a comprehensive list of adverse reactions and their frequencies.

Consult the complete prescribing information for drug interactions, including effects on CYP enzymes, transporters, and concomitant medications that may require dose adjustments or monitoring.

Consult the full prescribing information for pregnancy-related considerations.

Refer to prescribing information for lactation guidance.

Pediatric safety and efficacy information is detailed in the full label.

Dose modifications for organ impairment are specified in the complete prescribing information.

Dostarlimab is a humanized IgG4 monoclonal antibody that binds to PD-1 and blocks its interaction with PD-L1 and PD-L2, thereby releasing PD-1-mediated inhibition of the immune response, including the anti-tumor immune response.

Half-life: approximately 25.4 days. Clearance: 0.0078 L/h. Vd: 5.4 L. Steady-state reached by approximately 4 months. Linear PK in dose range evaluated.

Clinical efficacy and safety data supporting the approval are available in the full prescribing information and from the clinical trials listed below.

• GARNET — Dostarlimab in dMMR/MSI-H endometrial cancer and other solid tumors. Phase I, n=515.
  🔬 NCT02715284 ↗ 📄 Primary Publication ↗

Jemperli has FDA-approved indications across the following cancer types covered on PipelineEvidence: