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Ref Type Journal Article
PMID (42927858)
Authors Cercek A, Bachet JB, Folprecht G, Bando H, Seligmann J, Starling N, Riesco-Martinez MC, Alfonso PG, Smith D, Salvatore L, Flores EG, Mitry E, Chen E, Castillon JC, Morano F, Keränen SR, Aubin F, López CL, Lonardi S, Buchschacher G, Roderburg C, Gerlinger M, Modest D, Heinemann V, Goetze TO, Kato T, Park YS, Perkins G, Lemay F, Vickers M, Szijgyarto Z, Stjepanovic N, Haftchenary S, Diaz LA, Roodhart JML
Title Clinical Complete Response with Dostarlimab Monotherapy in dMMR/MSI-H Locally Advanced Rectal Cancer: First Results from the Global AZUR-1 Trial.
Journal Vol Issue Date Pages Journal Short Title
Annals of oncology : official journal of the European Society for Medical Oncology 2026 Oct 25 Ann Oncol
URL
Abstract Text Multimodal treatment with chemotherapy, radiation, and surgery for locally advanced rectal cancer (LARC) is a standard of care (SOC) associated with significant toxicity/morbidity. After TNT, clinical complete response (cCR) ranges between 21-41%, highlighting the need for novel approaches. dMMR/MSI-H tumors are exceptionally responsive to PD-1 blockade: in a pilot study, patients with dMMR/MSI-H LARC achieved durable responses after neoadjuvant dostarlimab. AZUR-1 is the first global registrational study evaluating dostarlimab monotherapy in adults with previously untreated stage II/III dMMR/MSI-H LARC.Dostarlimab 500 mg was administered intravenously Q3W for 9 cycles. Key endpoints include rate of sustained cCR for 12 months (cCR12) following end of treatment (EOT) with dostarlimab alone by investigator and independent central review (ICR), and composite rate of cCR12 (INV) + pathological CR (pCR).At data cutoff (April 20, 2026), 154 patients were enrolled (median follow-up [range]: 26.3 [2-36] months). Of 144 patients with ≥12 months follow-up, 68% achieved cCR12 (INV). pCR was achieved in 12/15 patients (80%) who underwent surgery after dostarlimab alone: cCR12+pCR rate was 76%. cCR12 (ICR) was less mature than investigator, as first cCR (ICR) was identified at later timepoints. 98% who achieved cCR maintained cCR for ≥12 months. Overall, 93% of patients were on study with no evidence of disease progression after treatment (dostarlimab ± SOC); 71% achieved this outcome with dostarlimab alone. There were no reported recurrences for patients in cCR or pCR. Safety was acceptable; grade ≥3 immune-mediated AEs occurred in 4 (3%) patients. PROs showed meaningful improvements from baseline to EOT for several domains.In this AZUR-1 interim analysis, 68% of patients achieved cCR12 and 76% achieved cCR12+pCR with dostarlimab alone and had no disease recurrences. These durable responses indicate the potential to eliminate the need for current SOC and redefine the curative-intent treatment paradigm with dostarlimab in dMMR/MSI-H LARC.NCT05723562.

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Molecular Profile Treatment Approach
Gene Name Source Synonyms Protein Domains Gene Description Gene Role
Therapy Name Drugs Efficacy Evidence Clinical Trials
Drug Name Trade Name Synonyms Drug Classes Drug Description
Gene Variant Impact Protein Effect Variant Description Associated with drug Resistance
Molecular Profile Indication/Tumor Type Response Type Therapy Name Approval Status Evidence Type Efficacy Evidence References
MSH6 negative rectum cancer sensitive Dostarlimab-gxly FDA approved - On Companion Diagnostic Actionable In a Phase II trial (AZUR-1) that supported FDA approval, Jemperli (dostarlimab-gxly) treatment resulted in a composite rate of clinical complete response for 12 months (cCR12) of 68% in patients (n=144) with previously untreated microsatellite instability-high (MSI-H) or mismatch repair-deficient (dMMR, defined by the loss of MLH1, PMS2, MSH2, or MSH6 expression by IHC) stage II/III locally advanced rectal cancer, with 76% of patients achieved cCR12 and CR (PMID: 42927858; NCT05723562). detail... detail... 42927858
MLH1 negative rectum cancer sensitive Dostarlimab-gxly FDA approved - On Companion Diagnostic Actionable In a Phase II trial (AZUR-1) that supported FDA approval, Jemperli (dostarlimab-gxly) treatment resulted in a composite rate of clinical complete response for 12 months (cCR12) of 68% in patients (n=144) with previously untreated microsatellite instability-high (MSI-H) or mismatch repair-deficient (dMMR, defined by the loss of MLH1, PMS2, MSH2, or MSH6 expression by IHC) stage II/III locally advanced rectal cancer, with 76% of patients achieved cCR12 and CR (PMID: 42927858; NCT05723562). detail... 42927858 detail...