Jemperli (dostarlimab-gxly)
/ AnaptysBio, GSK, Sagard Healthcare
- LARVOL DELTA
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July 17, 2026
Watch-and-wait (W&W) strategy for dostarlimab in localized deficient dMMR/MSI-H gastroesophageal adenocarcinoma (GEA): Results from the first interim analysis of the GERCOR-GONO DEWI phase II study
(ESMO 2026)
- No abstract available
dMMR • MSI-H • P2 data • Gastroesophageal Junction Adenocarcinoma • Microsatellite Instability • Oncology • Solid Tumor • MSI
July 17, 2026
Consolidation XELOX Plus Dostarlimab After Chemoradiation (CRT) With Optional Adjuvant Dostarlimab in pMMR/MSS or MSI-Low Locally Advanced Rectal Cancer (LARC): The IMMUNOSTAR Phase II Randomized Trial (GOIRC-02-2024)
(ESMO 2026)
- No abstract available
Clinical • Metastases • P2 data • pMMR • Colorectal Cancer • Oncology • Rectal Cancer • Solid Tumor
July 17, 2026
Genotype-Restricted Activity of Niraparib Plus Dostarlimab in HRD-Positive Solid Tumors: A Translational Phase II Study
(ESMO 2026)
- No abstract available
P2 data • Oncology • Solid Tumor • HRD
July 17, 2026
PRODIGE 90 (PREDIR-NEOREC). Neoadjuvant dostarlimab with short course radiotherapy in a watch-and-wait strategy for microsatellite unstable or mismatch repair-deficient locally advanced rectal cancer patients: a randomized phase II trial
(ESMO 2026)
- No abstract available
Clinical • dMMR • Metastases • Mismatch repair • P2 data • Colorectal Cancer • Oncology • Rectal Cancer • Solid Tumor
July 17, 2026
RODEO: pReOperative Dostarlimab and Novel Therapies in Endometrial Cancer
(ESMO 2026)
- No abstract available
Endometrial Cancer • Oncology • Solid Tumor
July 17, 2026
Real-world outcomes of dostarlimab plus chemotherapy in US patients with stage III primary advanced endometrial cancer
(ESMO 2026)
- No abstract available
Clinical • Metastases • Real-world • Real-world evidence • Endometrial Cancer • Oncology • Solid Tumor
July 17, 2026
Real-world outcomes of dostarlimab plus chemotherapy in US patients with MMRp/MSS primary advanced or recurrent endometrial cancer (pA/R EC): Subgroup analyses by histology and age
(ESMO 2026)
- No abstract available
Clinical • Metastases • Real-world • Real-world evidence • Endometrial Cancer • Oncology • Solid Tumor
July 17, 2026
Real-world data from the French early access program (EAP) of dostarlimab plus chemotherapy (DOST+CT) in dMMR/MSI-H primary advanced or recurrent endometrial cancer (pA/R EC)
(ESMO 2026)
- No abstract available
Clinical • dMMR • Metastases • MSI-H • Real-world • Real-world evidence • Endometrial Cancer • Microsatellite Instability • Oncology • Solid Tumor • MSI
July 17, 2026
Differential immune profiling of short- and long-responders to dostarlimab in recurrent or advanced MMR-deficient endometrial carcinoma (GEICO 143-T/SERENA Study).
(ESMO 2026)
- No abstract available
dMMR • Metastases • Endometrial Cancer • Oncology • Solid Tumor
July 17, 2026
Niraparib and dostarlimab plus radiotherapy (RT) in locally advanced head and neck squamous cell carcinoma (LA-HNSCC) patients (TTCC-2022-01 RADIAN).
(ESMO 2026)
- No abstract available
Clinical • Late-breaking abstract • Metastases • Head and Neck Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck
July 17, 2026
Clinical Complete Response With Dostarlimab Monotherapy in dMMR/MSI-H Locally Advanced Rectal Cancer (LARC): First Results From the Global Registrational AZUR-1 Trial
(ESMO 2026)
- No abstract available
Clinical • dMMR • Late-breaking abstract • Metastases • Monotherapy • MSI-H • Colorectal Cancer • Microsatellite Instability • Oncology • Rectal Cancer • Solid Tumor • MSI
August 29, 2026
Delayed Immune Checkpoint InhibitorâInduced Hepatitis Nine Weeks After Dostarlimab: Importance of Early Recognition and Immunosuppressive Management
(ACG 2026)
- "Clinicians should maintain ICI hepatitis on the differential weeks to months after therapy as to not delay appropriate treatment and educate patients on potential side-effects even after cessation of the medication. Figure: A. Mixed inflammation and bile ductular proliferation in the portal areas with ascending cholangitis-like features (numerous neutrophils around the bile ductules) Figure: B. Relatively easily identifiable eosinophils (arrows) C. Lobular inflammation with prominent lympho-histiocytic proliferation, focal sinusoidal lymphocytosis, and acidophil bodies (arrows)"
Checkpoint inhibition • Autoimmune Hepatitis • Endometrial Adenocarcinoma • Endometrial Cancer • Hepatology • Immunology • Inflammation • Liver Failure • Oncology • Solid Tumor
August 29, 2026
Unexpected Biopsy Diagnosis of ICI Enterocolitis in the Setting of Incongruent Endoscopic Findings
(ACG 2026)
- "The rate of ICI enterocolitis associated with dostarlimab is less than 10 percent...The patient was started on daily prednisone which resulted in symptomatic improvement...Therapy with the ICI can typically be resumed if response to corticosteroids is observed and the patient is able to be tapered off steroids. Figure: Terminal ileum Figure: Ileocecal valve"
Biopsy • IO biomarker • Endometrial Cancer • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Solid Tumor • CRP
August 29, 2026
Circulating Tumor DNA Kinetics Predict Pathologic Response and Inform Non-Operative Management in dMMR/MSI-H Colorectal Cancer on Neoadjuvant Immunotherapy: A Meta-Analysis
(ACG 2026)
- "PD-1 plus CTLA-4 combinations were most frequently administered, particularly Nivolumab with Ipilimumab, followed by PD-1 monotherapy, including Pembrolizumab and Dostarlimab. Thirty-six studies involving 1,312 patients met inclusion criteria. Baseline ctDNA positivity was observed in 89% of patients (95% CI, 85â93%). ctDNA clearance during neoadjuvant therapy occurred in 72% (95% CI, 64â80%)."
Circulating tumor DNA • dMMR • IO biomarker • MSI-H • Retrospective data • Colorectal Cancer • Microsatellite Instability • Oncology • Solid Tumor • MSI
September 25, 2026
The economic value of mismatch repair-guided immunotherapy in endometrial cancer: companion testing and patient selection.
(PubMed, Front Med (Lausanne))
- "We summarize practical testing pathways based on four-protein immunohistochemistry, reflex mutL homolog 1 (MLH1) promoter methylation, MSI assays, and selective next-generation sequencing; review MMR-stratified evidence from major immunotherapy trials; and compare published cost-effectiveness analyses of pembrolizumab, dostarlimab, atezolizumab, durvalumab-based regimens, and pembrolizumab plus lenvatinib. Across studies, dMMR/MSI-H disease generally generates the largest quality-adjusted survival gains and the most favorable incremental cost-effectiveness ratios, whereas the economic case in pMMR/MSS disease is more sensitive to drug pricing and modeling assumptions. Overall, MMR testing can function as an allocation technology that prioritizes high-value treatment, while future work should harmonize testing, manage discordant results, refine biomarkers for pMMR tumors, and incorporate long-term survival, quality of life, equity, and value of information into economic..."
IO biomarker • Journal • Mismatch repair • Review • Endometrial Cancer • Microsatellite Instability • Oncology • Solid Tumor • MLH1 • MSI
April 23, 2025
Randomized phase II study of neoadjuvant (neoadj) anti-PD-1 dostarlimab (D) vs. D + anti-TIM-3 cobolimab (C) in high-risk resectable melanoma (mel) (NEO-MEL-T): Primary analysis.
(ASCO 2025)
- P2 | "Neoadj D+C was safe and efficacious. The 1-year EFS of 92% in Arm B was significantly improved relative to adjuvant anti-PD-1, and this combination warrants further investigation. Clinical trial information: NCT04139902."
Clinical • Late-breaking abstract • P2 data • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Solid Tumor • HAVCR2
September 22, 2026
Short-term Fasting Prior to PD-1/PD-L1 Inhibitor Therapy for of Advanced or Metastatic Skin Malignancy
(clinicaltrials.gov)
- P1 | N=10 | Active, not recruiting | Sponsor: University of Southern California | Trial completion date: Aug 2027 ➔ Mar 2028 | Trial primary completion date: Aug 2026 ➔ Mar 2027
Checkpoint inhibition • Trial completion date • Trial primary completion date • Oncology • Skin Cancer • Solid Tumor • LAG3
September 24, 2026
GSK's Jemperli (dostarlimab) accepted for review by Health Canada for patients with dMMR/MSI-H locally advanced rectal cancer
(Canada Newswire)
- "The SNDS will be reviewed under Health Canada's NOC/c policy and the Project Orbis pathway; an international collaborative review initiative led by the US Food and Drug Administration's Oncology Center of Excellence for oncology products....The submission is supported by positive data from the registrational phase II, single-arm AZUR-1 trial, which met its primary endpoint by demonstrating a meaningful and sustained clinical complete response rate at 12 months (cCR12), defined as no detectable signs of cancer for at least one year after treatment completion. The submission also included safety and tolerability data from AZUR-1, which were generally consistent with the known safety profile of dostarlimab. Data from AZUR-1 are planned for presentation at a scientific congress later in 2026."
Canada filing • dMMR • MSI-H • P2 data • Project Orbis • Microsatellite Instability • Rectal Cancer
September 24, 2026
Early-Onset Colorectal Cancer: Contemporary Management, Immunotherapy, and Organ Preservation.
(PubMed, Dis Colon Rectum)
- "After multidisciplinary review, neoadjuvant PD-1 blockade with dostarlimab was recommended...After shared decision-making, the patient elected nonoperative management with intensive surveillance rather than total mesorectal excision. He remained without clinical evidence of disease at 12-month follow-up."
IO biomarker • Journal • Colorectal Cancer • Constipation • Gastroenterology • Gastrointestinal Disorder • Genetic Disorders • Immunology • Inflammatory Bowel Disease • Oncology • Solid Tumor • MLH1
September 23, 2026
Organ Preservation in MSI-H Rectal Cancer
(IASGO 2026)
- "In the initial report, all 12 patients achieved a clinicalcomplete response after dostarlimab, without chemoradiotherapy or surgery...In Lynch syndrome, organ preservation further challenges the traditional risk-reducingsurgical paradigm and requires lifelong surveillance for metachronous colorectal and extracoloniccancers. Ultimately, immunotherapy may allow us to move beyond organ preservation toward treatmentpreservation, but long-term evidence of oncological safety and cure is still needed."
MSI-H • Colorectal Cancer • Genetic Disorders • Microsatellite Instability • Oncology • Rectal Cancer • Solid Tumor • MSI
November 02, 2024
TBCRC 056: A phase II study of neoadjuvant niraparib with dostarlimab for patients with BRCA- or PALB2-mutated breast cancer: Results from the ER+/HER2- cohort.
(SABCS 2024)
- "Further data from the TNBC cohort of this study are awaited. Given the reported activity of PD-1 inhibitors in the preoperative management of HR+ breast cancer, additional exploration of targeted non-chemotherapy approaches is of great interest in this pt population."
Clinical • IO biomarker • P2 data • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • BRCA • BRCA1 • BRCA2 • CD8 • ER • HER-2 • PALB2
November 12, 2023
Dostarlimab or pembrolizumab plus chemotherapy in previously untreated metastatic non-squamous non-small cell lung cancer: the randomized PERLA phase II trial.
(PubMed, Nat Commun)
- P2 | "Patients stratified by PD-L1 tumor proportion score and smoking status were randomized 1:1, receiving ≤35 cycles 500 mg dostarlimab or 200 mg pembrolizumab, ≤35 cycles 500 mg/m pemetrexed and ≤4 cycles cisplatin (75 mg/m) or carboplatin (AUC 5 mg/ml/min) Q3W. Safety profiles are similar between groups. In this study, DCT shows similar efficacy to PCT and demonstrates clinical efficacy as first-line treatment for patients with metastatic non-squamous NSCLC."
Journal • Metastases • P2 data • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor
September 12, 2026
IMPACT OF MISMATCH REPAIR STATUS ON OUTCOMES OF PATIENTS WHO RECEIVED IMMUNOTHERAPY FOR TREATMENT OF ENDOMETRIAL CANCER: A REAL -WORLD MULTI-CENTER RETROSPECTIVE STUDY
(IGCS 2026)
- "122 EC patients received IO (48.4% dostarlimab, 51.6% pembrolizumab). Baseline characteristics are summarized in Table 1. Most had stage III/IV disease (77.8%), were pMMR (74.6%), and received IO as primary treatment (66.3%)."
Mismatch repair • Real-world • Retrospective data • Endometrial Cancer • Oncology • Solid Tumor
October 21, 2022
Randomized Double-Blind Phase II Trial (PERLA) of Dostarlimab (dostar) + Chemotherapy (CT) vs Pembrolizumab (pembro) + CT in Metastatic Non-Squamous NSCLC: Primary Results
(ESMO-IO 2022)
- P2 | "Methods Pts with no known EGFR, ALK or other genomic aberrations actionable locally by targeted therapies, known PD-L1 status, ECOG PS 0–1, and no prior systemic tx for metastatic NSCLC were randomized 1:1 to dostar 500 mg or pembro 200 mg Q3W IV ≤35 cycles, both in combination with CT (4 cycles pemetrexed [pem; 500 mg/m2] + carboplatin [AUC 5 mg/mL/min] or cisplatin [75 mg/m2] then pem up to cycle 35) Q3W IV. Additional analyses (inc. PFS [secondary endpoint], PD-L1 sub-analyses and DOR [exploratory]) will be presented."
Clinical • P2 data • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • EGFR
July 01, 2026
SIX-YEAR SURVIVAL OUTCOMES WITH DOSTARLIMAB MONOTHERAPY IN PATIENTS WITH MISMATCH REPAIR DEFICIENT/MICROSATELLITE INSTABILITY-HIGH ENDOMETRIAL CANCER IN THE GARNET TRIAL
(IGCS 2026)
- P1 | "Dostarlimab monotherapy demonstrated sustained benefit at this analysis. ORR was 45.5% with a disease control rate of 60.1% (Table). Since the previous data cut (01Nov2021), a deepening of response was observed as 9 patients (21.4%) with previous PR achieved CR (previously 23 CR and 42 PR of 65 responders)."
Clinical • dMMR • Mismatch repair • Monotherapy • MSI-H • Endometrial Cancer • Microsatellite Instability • Oncology • Solid Tumor • MSI
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