Jemperli (dostarlimab-gxly) / AnaptysBio, GSK, Sagard Healthcare - LARVOL DELTA

Chemotherapy-Free Niraparib–Dostarlimab Regimen Achieves 50% pCR in Germline BRCA–Mutated TNBC (DocWire) - "At the time of surgery, 23 patients (50%) achieved a pCR (90% confidence interval [CI], 37.1%–62.9%), exceeding the prespecified efficacy benchmark of >43%. The study team observed residual disease in 12 patients (26.1%), including 4 with RCB-I, 5 with RCB-II, 2 with RCB-III, and one not calculable. An additional 11 patients (23.9%) crossed over to additional preoperative therapy prior to surgery....The pCR rates were identical between treatment strategies, with 50% pCR in the upfront combination group (Arm A; 90% CI, 31.1%–68.9%) and 50% in the niraparib lead-in group (Arm B; 90% CI, 31.9%–68.1%)."

P2 data • Estrogen Receptor Positive Breast Cancer • HER2 Negative Breast Cancer • Triple Negative Breast Cancer

BEHOLD-2: A phase I/II randomized study evaluating mocertatug rezetecan, a B7-H4-targeted antibody-drug conjugate, in combination with anti-cancer agents in patients with solid tumors (ESMO Asia 2025) - P1/2 | "GSK'584 will be combined with dostarlimab (500 mg every 3 weeks [Q3W]) in patients with EC (Module 1) and with bevacizumab (15 mg/kg Q3W) in patients with OC (Module 2). Wu J, et al. Ann Oncol 2023; 34(suppl2):Abstr3810."

Clinical • Combination therapy • P1/2 data • Endometrial Cancer • Oncology • Solid Tumor • VTCN1

Clinicopathologic features and outcomes in microsatellite instability-high (MSI-H) cancers: Real-world data from Western India community oncology (ESMO Asia 2025) - "Pembrolizumab (45%, n=9) was the most used ICI, followed by nivolumab (35%, n=7), dostarlimab (10%, n=2), toripalimab (0.5%, n=1); low-dose nivolumab (40mg) in n=6 showed 60% ORR. This study highlight a critical imperative for systematic MSI testing to enable timely precision immunotherapy, optimize survival, and bridge regional disparities in cancer care."

Clinical • IO biomarker • MSI-H • Real-world • Real-world evidence • Biliary Cancer • Cervical Cancer • Cholangiocarcinoma • Esophageal Cancer • Gastric Cancer • Gastroesophageal Cancer • Microsatellite Instability • Oncology • ARID1A • CHEK2 • KRAS • MLH1 • MSH6 • MSI • PD-L1 • PTEN • TP53

A New Direction in Endometrial Cancer Therapy-PD-1 and PD-L1 Immune Checkpoint Inhibitors-Where Will It Take Us? (PubMed, J Clin Med) - "Other inhibitors such as atezolizumab, dostarlimab, durvalumab, nivolumab and avelumab also demonstrate high clinical efficacy, as they prolong median PFS compared to the control group, but more studies are needed in much larger study groups to assess their safety and efficacy in different age groups. Future studies should focus on the efficacy of ICIs in younger groups of patients with EC, as well as on drugs from this group that are used less frequently in clinical trials than pembrolizumab, which would allow for a thorough comparison of the efficacy of drugs with each other and the selection of the drug individually to the patient's needs."

Checkpoint inhibition • Journal • Review • Endometrial Cancer • Oncology • Solid Tumor

Immunotherapy in advanced endometrial cancer with microsatellite instability: A systematic review. (PubMed, Farm Hosp) - "The efficacy of pembrolizumab and pembrolizumab-lenvatinib regimen appears promising. However, studies with larger sample size, longer follow-up and comparative design with subgroup analysis based on differences in microsatellite repair mechanisms are needed for proper therapeutic positioning."

Journal • Review • Endometrial Cancer • Fatigue • Gastroenterology • Gastrointestinal Disorder • Microsatellite Instability • Oncology • Solid Tumor • MSI

Real-World Evidence Study on PD-L1 Testing and Use of Immuno-Oncology (IO) Treatments Among Cancer Patients in the Helsinki and Uusimaa (HUS) Region, Finland (ISPOR-EU 2025) - "The IO-treatments included nivolumab, pembrolizumab, durvalumab, avelumab, atezolizumab, cemiplimab, dostarlimab, ipilimumab and tremelimumab. PD-L1 testing was most frequently done in patients with melanoma, colorectal, lung, breast, kidney and bladder cancer. In this study, which is part of the Collaboration Research (CORE) dataset of Medaffcon, we show the frequency of PD-L1 testing and use of IO-treatments in HUS region, Finland. Both PD-L1 testing and use of IO-treatments were most common among lung cancer patients. We also show a notable increase in both PD-L1 testing and use of IO-treatments over time."

Clinical • HEOR • Immuno-oncology • IO biomarker • Real-world • Real-world evidence • Bladder Cancer • Genito-urinary Cancer • Kidney Cancer • Lung Cancer • Melanoma • Oncology • Renal Cell Carcinoma • Solid Tumor • PD-L1

Advances in Tissue-Agnostic Targeting in Cancer Therapeutics: Current Approvals, Challenges, and Future Directions. (PubMed, Oncol Res) - "The purpose of this review is to explore the impact, safety, and challenges of tissue-agnostic therapies including pembrolizumab, dostarlimab, larotrectinib, entrectinib, repotrectinib, dabrafenib plus trametinib, selpercatinib, and trastuzumab deruxtecan. We discuss emergence of pan-histological biomarkers, such as neoantigen burden, current updates on trials as well as trial outlining strategies to refining patient selection, while also supporting broader access to biomarker testing. Collectively, these insights underscore the transformative role of tissue-agnostic therapies in precision oncology while emphasizing the ongoing need for research to optimize their application and overcome current barriers."

Biomarker • Journal • Pan tumor • Review • Oncology

Neoadjuvant Immune Checkpoint Inhibition in MSI-H/dMMR Colorectal Cancer: A Systematic Review of Prospective Trials Evaluating Efficacy, Pathologic Response, and Surgical Outcomes. (PubMed, J Gastrointest Cancer) - "Neoadjuvant immune checkpoint inhibition demonstrates high pathological and clinical response rates in dMMR/MSI-H colorectal cancer, with organ preservation achievable in selected rectal cancer patients. Neoadjuvant immunotherapy may become an alternative to surgery as the primary treatment for MSI-H/dMMR colorectal cancer if long-term quality of life is superior and toxicity and cost are competitive with standard surgical approaches. However, longer follow-up, predictive biomarkers, and randomized comparisons with upfront surgery are required before its routine clinical use."

Checkpoint inhibition • dMMR • IO biomarker • Journal • MSI-H • Review • Colon Cancer • Colorectal Adenocarcinoma • Colorectal Cancer • Microsatellite Instability • Oncology • Solid Tumor • MSI

Managing AKI in Immune Checkpoint Inhibitor Therapy: A Comprehensive Cancer Center Experience (KIDNEY WEEK 2025) - "Pembrolizumab was used in 63,2% (n=12); ipilimumab/nivolumab in 15,8% (n=3); cemiplimab in 10,5% (n=2); and dostarlimab and tislelizumab in 5,3% (n=1) each. Lab monitoring is essential, as symptoms may be absent. Multidisciplinary care warrants timely referral, diagnosis and treatment."

Checkpoint inhibition • Acute Kidney Injury • Infectious Disease • Nephrology • Oncology • Renal Disease • Solid Tumor

Retrospective review of bowel strictures in patients with mismatch repair deficient (MMRd) colorectal cancers (CRC) treated with immune checkpoint inhibitors (ICI): A single centre experience (ESMO-IO 2025) - "Treatment was evenly split between nivolumab and pembrolizumab (three pts each) and one received dostarlimab. These novel immune-related effects present with diverse symptoms and delayed onset, making diagnosis challenging. Thorough individual evaluation, close monitoring, identifying risk factors through a multimodal approach as well as further research into the immunological response are essential to improving patient care and safety.Legal entity responsible for the study The authors."

Checkpoint inhibition • dMMR • Mismatch repair • Retrospective data • Review • Colon Cancer • Colorectal Cancer • Oncology • Rectal Cancer • Solid Tumor

RW-NEDOS: Real-world Efficacy and Safety of Neoadjuvant Dostarlimab in Patients With dMMR/MSI-H Locally Advanced Rectal Cancer (clinicaltrials.gov) - P=N/A | N=50 | Recruiting | Sponsor: National Cancer Institute, Naples

dMMR • MSI-H • New trial • Real-world evidence • Colorectal Cancer • Microsatellite Instability • Oncology • Rectal Cancer • Solid Tumor

Tbcrc 056: a phase 2 study of neoadjuvant niraparib with dostarlimab for patients with BRCA- or PALB2-mutated breast cancer: results from the TNBC cohorts (SABCS 2025) - "ConclusionsIn pts with gBRCAm early TNBC, 18 wks of targeted therapy using PARPi and anti-PD1 agents, with or without 3-week PARPi lead-in, resulted in a pCR rate of 50%, and a statistically significant increase in sTILs from BL to 3 wks. Further ongoing correlative work may identify best candidates for this non-chemotherapy-based approach."

Clinical • IO biomarker • P2 data • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • BRCA • BRCA1 • BRCA2 • CD8 • ER • HER-2 • PALB2 • PD-L1

Outcomes of Immunotherapy in BRCA-Mutation Positive, Hormone-Receptor Positive, Breast Cancer: A Systematic Review (SABCS 2025) - "Mayer et al treated 18 patients with a combination of Niraparib and Dostarlimab in the neoadjuvant setting...Cortesi et al reported outcomes of Pembrolizumab and Carboplatin combination in 16 patients with gBRCA-m, HR+ m metastatic breast cancer...The addition of immunotherapy to chemotherapy provides an additional therapeutic option to combat BRCA-m, HR+ breast cancer with an acceptable safety profile. However, current studies are limited by the small sample sizes and the short follow-up times."

IO biomarker • Review • Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • BRCA • BRCA1 • BRCA2

Immunotherapy beyond trials: Dostarlimab in advanced endometrial cancer: A Portuguese multicenter experience (ESMO-IO 2025) - "Background Dostarlimab was available in Portugal for advanced or recurrent endometrial cancer post–platinum therapy via early access(EAP) since November 2021, with reimbursement from October 2024; its use with carboplatin and paclitaxel was authorized under EAP in June 2024. Discontinuation rate was 9.3%, 75% of which because of immunological-related AE.Conclusions This study demonstrates efficacy outcomes surpassing those reported in other real-world series and clinical trials, with no new safety signals and manageable toxicity in a heavily pretreated population. Our findings highlight the importance of real-world evidence in characterizing long-term responders and optimizing patient selection for dostarlimab in endometrial cancer.Legal entity responsible for the study The authors."

Clinical • Metastases • Carcinosarcoma • Endometrial Cancer • Oncology • Sarcoma • Solid Tumor

Results from COSTAR lung: cobolimab + dostarlimab + docetaxel and dostarlimab + docetaxel versus docetaxel alone in patients with previously treated advanced/metastatic (A/M) non-small cell lung cancer (NSCLC) (ESMO-IO 2025) - P3 | "Safety and immune-related toxicity were comparable across the applicable arms. Table: 241MO AE, adverse event; mo, months; N/A, not applicable; TE, treatment emergent Conclusions In COSTAR Lung, cobolimab + dostarlimab + docetaxel and dostarlimab + docetaxel did not meet the planned primary endpoint of survival (OS) compared with docetaxel alone.Clinical trial identification NCT04655976.Legal entity responsible for the study GSK."

Clinical • IO biomarker • Metastases • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • HAVCR2

NIRADO: Basket Trial Exploring the Efficacy and Safety of the Combination of Niraparib and Dostarlimab (clinicaltrials.gov) - P2 | N=51 | Terminated | Sponsor: Gustave Roussy, Cancer Campus, Grand Paris | Trial completion date: Dec 2027 ➔ Feb 2025 | Suspended ➔ Terminated; Abandon of the partner, GSK

Pan tumor • Platinum sensitive • Trial completion date • Trial termination • Biliary Cancer • Biliary Tract Cancer • Bladder Cancer • Clear Cell Renal Cell Carcinoma • Esophageal Adenocarcinoma • Esophageal Cancer • Gastric Adenocarcinoma • Gastric Cancer • Gastroesophageal Cancer • Gastroesophageal Junction Adenocarcinoma • Genito-urinary Cancer • Head and Neck Cancer • Oncology • Ovarian Serous Adenocarcinoma • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma • Renal Cell Carcinoma • Solid Tumor • ARID1A • ARID2 • BARD1 • BRCA1 • BRCA2 • BRIP1 • CDK12 • CHEK2 • DRD • FANCA • HER-2 • IDH1 • IDH2 • NBN • PBRM1 • RAD51 • RAD51C • RAD51D • RAD54L

Neoadjuvant immunotherapy for dMMR/MSI-H locally advanced rectal cancer patients: demystifying the 100% clinical complete response paradigm. (PubMed, Oncologist) - "shows a cCR rate of 100% that allowed sparing chemoradiation and surgery to all included patients. Here, we present three clinical cases of patients with dMMR and MSI-H LARC treated with neoadjuvant dostarlimab at three Italian institutions with radiological evidence of disease progression while on treatment and discuss potential similarities among them to understand when and how this apparently rare event may occur."

dMMR • Journal • MSI-H • Colorectal Cancer • Microsatellite Instability • Oncology • Rectal Cancer • Solid Tumor • MSI

GSK’s Jemperli now standard in endometrial cancer as reimbursement expands to 1st-line therapy (Korea Biomedical Review) - "Clinical evidence from the phase 3 RUBY trial has been central to the expanded use."

dMMR • MSI-H • Reimbursement • Endometrial Cancer

NICE recommends treatment for primary advanced or recurrent endometrial cancer (Pf Media) - "The National Institute for Health and Care Excellence (NICE) has issued final guidance recommending the use of Jemperli (dostarlimab) with platinum-based chemotherapy for first-line treatment of primary advanced or recurrent endometrial cancer with mismatch repair proficiency or microsatellite stability...Following the NICE decision, GSK is working with relevant health authorities in Wales and Northern Ireland to ensure expanded access for more patients across the United Kingdom in this first-line setting...GSK is now collaborating with stakeholders to provide access to patients in Scotland and has submitted a dossier to the Scottish Medicines Consortium (SMC) in preparation for appraisal."

NICE • pMMR • Reimbursement • Endometrial Cancer

Jemperli: "Jemperli on a steep growth trajectory with GSK guiding to greater than £2 billion ($2.7 billion) peak monotherapy sales" (AnaptysBio) - Corporate Presentation

Commercial • Endometrial Cancer • Gynecologic Cancers • Microsatellite Instability • Oncology • Uterine Cancer

TESARO, a GSK subsidiary, initiates litigation against AnaptysBio, Inc. (GSK Press Release) - "This action contends that recent conduct by AnaptysBio is in material breach of the existing license agreement with TESARO regarding the oncology treatment Jemperli (dostarlimab). The breach entitles TESARO to terminate the current license agreement, obtain a perpetual and irrevocable license to dostarlimab, and to reduce the royalties and milestone payments due by TESARO to AnaptysBio by 50%."

Corporate lawsuit • Endometrial Cancer

Combination Niraparib and Dostarlimab Therapy for Recurrent or Persistent Uterine Serous Carcinoma (clinicaltrials.gov) - P2 | N=8 | Active, not recruiting | Sponsor: Casey Cosgrove | Trial primary completion date: Dec 2025 ➔ Sep 2025

Trial primary completion date • Endometrial Adenocarcinoma • Endometrial Cancer • Endometrial Serous Adenocarcinoma • Oncology • Solid Tumor • Uterine Cancer

A Study of Cobolimab Plus Dostarlimab in Pediatric and Young Adult Participants With Cancer (clinicaltrials.gov) - P1/2 | N=83 | Active, not recruiting | Sponsor: GlaxoSmithKline | Trial completion date: Jan 2032 ➔ Oct 2026 | Trial primary completion date: Jan 2032 ➔ Oct 2026

Trial completion date • Trial primary completion date • Brain Cancer • Diffuse Intrinsic Pontine Glioma • Ependymoma • Glioblastoma • Glioma • Hematological Malignancies • Hepatoblastoma • Hepatocellular Cancer • Liver Cancer • Lymphoma • Melanoma • Oncology • Osteosarcoma • Pediatrics • Rhabdomyosarcoma • Sarcoma • Solid Tumor

Cost Calculator of Immunotherapies in 1L Endometrial Cancer Treatment for the Deficient Mismatch Repair, Proficient Mismatch Repair, and Intention-to-Treat Populations From the Brazilian Private Healthcare System (ISPOR-EU 2025) - P3 | "Dostarlimab presented the lowest treatment cost among the immunotherapy options in 1L for EC irrespective of mutation status, which may lead to better budget allocation and access to the novel therapy."

Clinical • dMMR • IO biomarker • Mismatch repair • pMMR • Endometrial Cancer • Oncology • Solid Tumor

Early access authorization renewed for the specialty JEMPERLI (dostarlimab) in the indication “in combination with carboplatin and paclitaxel for the treatment of adult patients with newly diagnosed or recurrent advanced endometrial cancer, who do not have a deficiency in the base mismatch repair/microsatellite instability system…and who are candidates for systemic therapy.“ [Google translation] (Haute Autorité de santé)

European regulatory • pMMR • Endometrial Cancer • Gynecologic Cancers • Oncology