For US Healthcare Professionals

For US HCPs

JEMPERLI (dostarlimab-gxly) Logo

REDEFINE YOUR APPROACH

to MSI-H/dMMR locally advanced rectal cancer (LARC)

JEMPERLI is the FIRST AND ONLY FDA-approved immunotherapy for patients with MSI-H/dMMR LARC1*

*Stage II/III.1

This indication is approved under accelerated approval based on sustained clinical complete response for 12 months. The long-term risk of relapse is unknown, with additional follow-up expected. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).

JEMPERLI is the only FDA-approved immunotherapy for MSI-H/dMMR LARC backed by evidence from 2 trials1

Pie chart icon.

Initial results from MSKCC 19-288

a single-center, supported collaborative trial1-3

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Further evidence from AZUR-1

a global, multicenter, registrational trial1,4

FDA approval icon.

FDA approval

with Breakthrough Therapy Designation1

Dostarlimab-gxly (JEMPERLI) is the only FDA-approved immunotherapy for patients with dMMR/MSI-H LARC recommended by the National Comprehensive Cancer Network® (NCCN®)1,5

NCCN Category 2A Preferred Option icon.

NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) recommend dostarlimab-gxly (JEMPERLI) as an immunotherapy option for patients with previously untreated dMMR/MSI-H locally advanced rectal cancer (NCCN category 2A, preferred)5

Category 2A – Based upon lower-level evidence, there is uniform NCCN consensus (≥85% support of the Panel) that the intervention is appropriate.5

Preferred intervention – Interventions that are based on superior efficacy, safety, and evidence; and, when appropriate, affordability.5

 

dMMR=mismatch repair deficient; MSI-H=microsatellite instability-high; MSKCC=Memorial Sloan Kettering Cancer Center.

      cCR=clinical complete response; cCR12=clinical complete response for 12 months; CT=computed tomography; ECOG PS=Eastern Cooperative Oncology Group Performance Status; ICR=independent central review; IV=intravenous; MRI=magnetic resonance imaging; Q3W=every 3 weeks.

      In AZUR-1, many patients achieved complete responses that were sustained for 12 months with JEMPERLI1

      At this pre-specified interim analysis, some patients who achieved cCR12 per investigator assessment were not yet evaluable by ICR1*

      AZUR-1 efficacy endpoints infographic.

      ICR assessment strives to remove bias by standardizing review with predefined imaging and endoscopic assessments. Investigator assessment is performed collaboratively with the MDT and also includes clinical context which is reflective of clinical practice. Some differences between assessments are anticipated, but results are complementary.7,8 At data cutoff, cCR12 results have 87% concordance.9

       

      SECONDARY EFFICACY OUTCOMES

      • 79% (n=121/154; 95% CI: 71, 85) objective response at the first or second assessment after JEMPERLI per ICR, including cCR, nCR, and PR rates of 28%, 29%, and 22%, respectively, and 82% (n=126/154; 95% CI: 75, 88) per investigator, including cCR, nCR, and PR rates of 66%, 6%, and 10%, respectively1

       

      PATHOLOGICAL COMPLETE RESPONSE

      • 80% of the patients (n=12/15) who underwent rectal cancer surgery after treatment with JEMPERLI alone were found to have pCR without additional prior chemotherapy and radiation therapy1

       

      *Patients with an opportunity for at least 12 months of follow-up from the date at which cCR was first observed. Non-evaluable patients include those who achieved cCR and had <12 months of follow-up at data cutoff. 38 patients who achieved cCR per ICR are still being followed for cCR12.1

      Rectum icon.

      Data were collected on whether patients were able to avoid rectal cancer surgery and preserve their rectum1

      • 83% of patients did not undergo surgery (n=128/154), while 17% (n=26/154) underwent surgery (with or without additional systemic therapy or radiation)

      Median follow-up of 26 months for the overall population. Data cutoff April 20, 2026. Confidence intervals determined using Clopper-Pearson method.1

      CI=confidence interval; MDT=multidisciplinary team; pCR=pathological complete response.

          CRT=chemoradiotherapy; EFS3=event-free survival at 3 years.

          The results from MSKCC 19-288 led to FDA Breakthrough Therapy Designation for JEMPERLI

          • All patients achieved cCR; therefore, the ORR reflects the cCR rate1
          • No patients proceeded to CRT and/or rectal cancer surgery; therefore, the cCR12 rate reflects the cCR12+pCR rate1
          MSKCC 19-288 efficacy outcomes infographic.
          EFS3 rate icon.

          89% of evaluable patients were alive and free of disease progression at 3 years (n=24/27)1,9†

          • 1 patient had a local recurrence treated with lymphadenectomy

          • 1 patient withdrew and 1 patient died unrelated to disease under study

          Median follow-up of 41 months for the overall population. Data cutoff January 28, 2026.9

          *Patients with an opportunity for at least 12 months of follow-up on nonoperative management. Median follow-up of 43 months.9

          †Binary endpoint. Patients with an opportunity for at least 3 years of follow-up from the first dose of JEMPERLI. Median follow-up of 36 months.9

          Safety profile in AZUR-1

          Of the 154 patients in AZUR-11:

          • 3% of patients permanently discontinued JEMPERLI due to adverse reactions. Adverse reactions leading to discontinuation occurred in 1 patient each and include lichen planus, hepatitis, increased amylase, and intestinal obstruction occurring at the tumor site1
          • Serious adverse reactions occurred in 20% of patients, including (in ≥1% of patients) colitis (1.9%), gastritis, rectal stenosis, and intestinal obstruction occurring at the tumor site (1.3% each)1
          • The most common adverse reactions (≥15%) were fatigue, rash, diarrhea, and pruritus1

            JEMPERLI is a single-agent treatment administered over ~6 months1

            30-minute IV infusion every 3 weeks for 9 cycles1

            JEMPERLI dosing and administration for MSI-H/dMMR LARC infographic.

            Choose JEMPERLI—the first and only FDA-approved immunotherapy for patients with MSI-H/dMMR LARC1

            Resources for Healthcare Professionals and Patients 

            AZUR-1 and MSKCC 19-288 Core Summary Brochure.

            HCP Core Summary Brochure

            Learn more about the AZUR-1 and MSKCC 19-288 trials and the use of JEMPERLI in patients with MSI-H/dMMR LARC.

            DOWNLOAD RESOURCES
            MSI-H/dMMR LARC Patient Brochure.

            Patient Brochure

            Find information about JEMPERLI for patients with MSI-H/dMMR LARC.

            DOWNLOAD RESOURCES

            Indication & Important Safety Information

            Indication

            Important Safety Information

            Indication

            JEMPERLI, as a single agent, is indicated for the treatment of adult patients with Stage II/III, locally advanced rectal cancer (LARC) that is microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR), as determined by an FDA-authorized test for solid tumors. This indication is approved under accelerated approval based on sustained clinical complete response for 12 months. The long-term risk of relapse is unknown, with additional follow-up expected. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).

            Important Safety Information

            Severe and Fatal Immune-Mediated Adverse Reactions

            • Immune-mediated adverse reactions, which can be severe or fatal, can occur in any organ system or tissue and can occur at any time during or after treatment with a PD-1/PD-L1–blocking antibody, including JEMPERLI.
            • Monitor closely for signs and symptoms of immune-mediated adverse reactions. Evaluate liver enzymes, creatinine, and thyroid function tests at baseline and periodically during treatment. For suspected immune-mediated adverse reactions, initiate appropriate workup to exclude alternative etiologies, including infection. Institute medical management promptly, including specialty consultation as appropriate.
            • Based on the severity of the adverse reaction, withhold or permanently discontinue JEMPERLI. In general, if JEMPERLI requires interruption or discontinuation, administer systemic corticosteroids (1 to 2 mg/kg/day prednisone or equivalent) until improvement to ≤Grade 1. Upon improvement to ≤Grade 1, initiate corticosteroid taper and continue to taper over at least 1 month. Consider administration of other systemic immunosuppressants in patients whose immune-mediated adverse reaction is not controlled with corticosteroids.

            Immune-Mediated Pneumonitis

            • JEMPERLI can cause immune-mediated pneumonitis, which can be fatal. In patients treated with other PD-1/PD-L1–blocking antibodies, the incidence of pneumonitis is higher in patients who have received prior thoracic radiation. Pneumonitis occurred in 2% (15/759) of patients, including Grade 2 (1.2%), Grade 3 (0.7%), and Grade 4 (0.1%) pneumonitis.

            Immune-Mediated Colitis

            • Colitis occurred in 1.2% (9/759) of patients, including Grade 2 (0.7%) and Grade 3 (0.5%) adverse reactions. Cytomegalovirus infection/reactivation have occurred in patients with corticosteroid-refractory immune-mediated colitis. In such cases, consider repeating infectious workup to exclude alternative etiologies.

            Immune-Mediated Hepatitis

            • JEMPERLI can cause immune-mediated hepatitis, which can be fatal. Grade 3 hepatitis occurred in 0.5% (4/759) of patients.

            Immune-Mediated Endocrinopathies

            • Adrenal Insufficiency
              • Adrenal insufficiency occurred in 1.1% (8/759) of patients, including Grade 2 (0.4%) and Grade 3 (0.7%). For Grade 2 or higher adrenal insufficiency, initiate symptomatic treatment per institutional guidelines, including hormone replacement as clinically indicated. Withhold or permanently discontinue JEMPERLI depending on severity.
            • Hypophysitis
              • JEMPERLI can cause immune-mediated hypophysitis. Grade 2 hypophysitis occurred in 0.3% (2/759) of patients. Initiate hormone replacement as clinically indicated. Withhold or permanently discontinue JEMPERLI depending on severity.
            • Thyroid Disorders
              • Grade 2 thyroiditis occurred in 0.4% (3/759) of patients. Grade 2 hypothyroidism occurred in 8% (58/759) of patients. Hyperthyroidism occurred in 2.2% (17/759) of patients, including Grade 2 (2.1%) and Grade 3 (0.1%). Initiate thyroid hormone replacement or medical management of hyperthyroidism as clinically indicated. Withhold or permanently discontinue JEMPERLI depending on severity.
            • Type 1 Diabetes Mellitus, Which Can Present with Diabetic Ketoacidosis
              • JEMPERLI can cause type 1 diabetes mellitus, which can present with diabetic ketoacidosis. Grade 3 type 1 diabetes mellitus occurred in 0.1% (1/759) of patients. Monitor patients for hyperglycemia or other signs and symptoms of diabetes. Initiate treatment with insulin as clinically indicated. Withhold or permanently discontinue JEMPERLI depending on severity.

            Immune-Mediated Nephritis with Renal Dysfunction

            • JEMPERLI can cause immune-mediated nephritis, which can be fatal. Grade 2 nephritis, including tubulointerstitial nephritis, occurred in 0.4% (3/759) of patients.

            Immune-Mediated Dermatologic Adverse Reactions

            • JEMPERLI can cause immune-mediated rash or dermatitis. Bullous and exfoliative dermatitis, including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and drug rash with eosinophilia and systemic symptoms (DRESS), have occurred with PD-1/PD-L1–blocking antibodies. One patient receiving JEMPERLI experienced Grade 3 SJS, which resolved. Topical emollients and/or topical corticosteroids may be adequate to treat mild to moderate non-bullous/exfoliative rashes. Withhold or permanently discontinue JEMPERLI depending on severity.

            Other Immune-Mediated Adverse Reactions

            • The following clinically significant immune-mediated adverse reactions occurred in <1% of the 759 patients treated with JEMPERLI or were reported with the use of other PD-1/PD-L1–blocking antibodies. Severe or fatal cases have been reported for some of these adverse reactions.
              • Nervous System: Meningitis, encephalitis, myelitis and demyelination, myasthenic syndrome/myasthenia gravis, Guillain-Barré syndrome, nerve paresis, autoimmune neuropathy
              • Cardiac/Vascular: Myocarditis, pericarditis, vasculitis
              • Ocular: Uveitis, iritis, other ocular inflammatory toxicities. Some cases can be associated with retinal detachment. Various grades of visual impairment to include blindness can occur
              • Gastrointestinal: Pancreatitis, including increases in serum amylase and lipase levels, gastritis, duodenitis
              • Musculoskeletal and Connective Tissue: Myositis/polymyositis, rhabdomyolysis and associated sequelae including renal failure, arthritis, polymyalgia rheumatica
              • Endocrine: Hypoparathyroidism
              • Hematologic/Immune: Autoimmune hemolytic anemia, aplastic anemia, hemophagocytic lymphohistiocytosis, systemic inflammatory response syndrome, histiocytic necrotizing lymphadenitis (Kikuchi lymphadenitis), sarcoidosis, immune thrombocytopenia, solid organ transplant rejection, other transplant (including corneal graft) rejection
              • Other: Myocarditis-Myositis-Myasthenia Gravis (or Myasthenia-Like) Overlap Syndrome, reported as the co-occurrence of either two or all three adverse reactions.

            Infusion-Related Reactions

            • Severe or life-threatening infusion-related reactions have been reported with PD-1/PD-L1–blocking antibodies. Severe infusion-related reactions (Grade 3) occurred in 0.1% (1/759) of patients. Monitor patients for signs and symptoms of infusion-related reactions. Interrupt or slow the rate of infusion or permanently discontinue JEMPERLI based on severity of reaction.

            Complications of Allogeneic HSCT

            • Fatal and other serious complications can occur in patients who receive allogeneic hematopoietic stem cell transplantation (HSCT) before or after treatment with a PD-1/PD-L1–blocking antibody, which may occur despite intervening therapy. Monitor patients closely for transplant-related complications and intervene promptly.

            Embryo-Fetal Toxicity and Lactation

            • Based on its mechanism of action, JEMPERLI can cause fetal harm. Advise pregnant women of the potential risk to a fetus. Advise women of reproductive potential to use effective contraception during treatment with JEMPERLI and for 4 months after their last dose. Because of the potential for serious adverse reactions from JEMPERLI in a breastfed child, advise women not to breastfeed during treatment with JEMPERLI and for 4 months after their last dose.

            Common Adverse Reactions

            The most common adverse reactions (≥15%) were fatigue, rash, diarrhea, and pruritus. The most common Grade 3 or 4 laboratory abnormalities (≥2%) were decreased lymphocytes, decreased hemoglobin, and increased AST.

             

            Please see full Prescribing Information, including Medication Guide.

            To report SUSPECTED ADVERSE REACTIONS, contact GSK at gsk.public.reportum.com or 1-888-825-5249 or
            FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

            References

            1. JEMPERLI. Prescribing Information GSK; 2026.

            2. Cercek A, et al. N Engl J Med. 2025;392(23):2297-2308.

            3. Cercek A, et al. N Engl J Med. 2022;386(25):2363-2376.

            4. Cercek A, et al. Clin Colorectal Cancer. 2025;24(2):325-330.

            5. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Rectal Cancer V.2.2026. © National Comprehensive Cancer Network; 2026. All rights reserved. Accessed May 1, 2026. To view the most recent and complete version of the guideline, go online to NCCN.org.*

            6. ClinicalTrials.gov. A study of dostarlimab in untreated dMMR/MSI-H locally advanced rectal cancer (AZUR-1). Accessed August 19, 2026. https://clinicaltrials.gov/study/NCT05723562

            7. Ford R, et al. Eur J Cancer. 2009;45(2):268-274.

            8. Zettler ME. Cancers (Basel). 2025;17(7):1096.

            9. Data on file, GSK.

            10. Cercek A, et al. N Engl J Med. 2025;392(23)(suppl):2297-2308.

            11. Cercek A, et al. N Engl J Med. 2025;392(23)(protocol):2297-2308.
               

              *NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use.