DOSTARLIMAB-GXLY INJ,SOLN

Clinical Criteria Summary

Primary advanced or recurrent endometrial cancer (EC)
Mismatch repair deficient (dMMR) recurrent or advanced solid tumors with progressive disease on prior treatment and no satisfactory treatment options
Off-label use in dMMR locally advanced rectal cancer

Endometrial cancer combination therapy: 500 mg IV every 3 weeks for 6 cycles, then 1000 mg every 6 weeks
Endometrial cancer single agent: 500 mg IV every 3 weeks for 4 cycles, then 1000 mg every 6 weeks
Solid tumors (single agent): 500 mg IV every 3 weeks for 4 cycles, then 1000 mg every 6 weeks
Neoadjuvant therapy in rectal cancer: 500 mg IV every 3 weeks x 6 cycles
Dosage form: 500 mg/10 mL [50 mg/mL] solution in single-dose vial

Uterine Cancer (Stage III No Residual Disease, Stage III Preop Gross Nodal Disease, Stage IV): Carcinosarcoma -> PC + dostarlimab, then dostarlimab maintenance for up to 3 years
Rectal Cancer (Stage II and III dMMR/MSI-H): Dostarlimab x6 months as neoadjuvant therapy
NCCN Guidelines v2.2026 Endometrial Carcinoma:
Primary or adjuvant therapy (Stage I-IV): PC + dostarlimab for Stage III-IV (Category 1)
Recurrent disease: PC + dostarlimab (Category 1)
Second or subsequent line therapy: MSI-H/dMMR tumors -> Dostarlimab (Category 2A)
NCCN Guidelines v2.2026 dMMR/MSI-H Rectal Cancer: Neoadjuvant, preferred -> Dostarlimab or nivolumab or pembrolizumab for up to 6 months (Category 2A)

Boxed Warnings: None
Contraindications: None
Other Warnings: Severe and fatal immune-mediated adverse reactions, infusion-related reactions, complications of allogeneic hematopoietic stem cell transplant, embryo-fetal toxicity
Top 5 Adverse Events (Endometrial Cancer): Decreased hemoglobin, increased creatinine, peripheral neuropathy, decreased white blood cell count, fatigue
Top 5 Adverse Events (dMMR Solid Tumors): Fatigue/asthenia, anemia, diarrhea, nausea

Autoimmune disease
Immunosuppression requiring a corticosteroid equivalent to > 10 mg per day of prednisone
Primary Immunodeficiency
History of allogeneic hematopoietic stem cell or solid organ transplant
Known pregnancy
Lactating

Care is provided by a VA/VA Community Care oncology or hematology provider
Eastern Cooperative Oncology Group (ECOG) performance status 0-2
Goals of care and role of Palliative Care consult have been discussed and documented

For females who can become pregnant: Pregnancy must be excluded prior to receiving dostarlimab
For females who can become pregnant: Counseling provided on potential risks vs. benefits of treatment and the use of effective contraception during therapy and for 4 months after stopping treatment