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

Predictive biomarkers of response to immune checkpoint inhibitors in mismatch repair-deficient endometrial cancer (Ther Adv Med Oncol, PubMed) - "In this review, we evaluate the predictive value of established biomarkers, including Tumor Mutation Burden (TMB) and PD-L1 expression, for response to ICIs in the MMRd EC population...In sum, transcriptomic and multi-omics ML-based signatures in EC suggest that composite models outperform single biomarkers for risk stratification and putative ICI prediction. The current evidence base is largely retrospective, TCGA-derived, and inference-based."

dMMR • MSI-H • Retrospective data • Review • Endometrial Cancer

Predictive biomarkers of response to immune checkpoint inhibitors in mismatch repair-deficient endometrial cancer (Ther Adv Med Oncol, PubMed) - "In this review, we evaluate the predictive value of established biomarkers, including Tumor Mutation Burden (TMB) and PD-L1 expression, for response to ICIs in the MMRd EC population...In sum, transcriptomic and multi-omics ML-based signatures in EC suggest that composite models outperform single biomarkers for risk stratification and putative ICI prediction. The current evidence base is largely retrospective, TCGA-derived, and inference-based."

dMMR • MSI-H • Retrospective data • Review • Endometrial Cancer

Nonoperative Management of Mismatch Repair-Deficient Tumors. (PubMed, N Engl J Med) - P2 | "Among patients with early-stage dMMR solid tumors that were amenable to curative-intent surgery, neoadjuvant PD-1 blockade led to organ preservation in a high proportion of patients. (Funded by Swim Across America and others; ClinicalTrials.gov number, NCT04165772.)."

dMMR • Journal • Mismatch repair • Colorectal Cancer • Oncology • Rectal Cancer • Solid Tumor

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

FIRST/ENGOT-OV44 trial: Does the addition of dostarlimab (dost) impact niraparib (nira) tolerability, exposure, or dose modification? (ESMO 2025) - P3 | "The FIRST/ENGOT-OV44 trial (NCT03602859) investigated the addition of dost to 1L platinum-based chemotherapy (PBCT) and nira MT ± bevacizumab (bev). a Among pts who received nira MT. b Thrombocytopenia and anemia include selected preferred terms in the same medical concept, mapped through standardized MedDRA queries."

Oncology • Ovarian Cancer • Solid Tumor

First-Time-in-Human Study of GSK4381562 in Participants With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=152 | Active, not recruiting | Sponsor: GlaxoSmithKline | Recruiting ➔ Active, not recruiting

Enrollment closed • Monotherapy • Breast Cancer • Colorectal Cancer • Endometrial Cancer • Gastric Cancer • Head and Neck Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor • Squamous Cell Carcinoma of Head and Neck

Severe Presentations of Cutaneous Lupus in Patients on Immune Checkpoint Inhibitors (ICIs) (AAD 2026) - "A 77-year-old female with endometrial adenocarcinoma developed widespread tense bullae and mucosal erosions after three cycles of pembrolizumab with carboplatin/paclitaxel...Treatment included discontinuation of pembrolizumab, high-dose prednisone, and hydroxychloroquine, which successfully achieved disease control. The second case, a 74-year-old female with stage IIIC clear cell uterine carcinoma, developed a diffuse morbilliform eruption with flaccid bullae and denuded plaques after four cycles of dostarlimab with carboplatin/paclitaxel...Despite systemic steroid therapy and comprehensive supportive wound care, her course was complicated by malnutrition and multisystem organ involvement, and she expired approximately three months after onset of the rash. These cases emphasize the importance of early biopsy, clinicopathologic correlation, and prompt immunosuppressive therapy in managing rare, severe cutaneous irAEs during ICI treatment (2)."

Checkpoint inhibition • Clinical • Cutaneous Lupus Erythematosus • Dermatitis • Discoid Lupus Erythematosus • Endometrial Adenocarcinoma • Endometrial Cancer • Immunology • Inflammatory Arthritis • Lupus • Oncology • Solid Tumor • Steven-Johnson Syndrome • Uterine Cancer

FIRST/ENGOT-OV44: A phase 3 clinical trial of dostarlimab (dost) and niraparib (nira) in first-line (1L) advanced ovarian cancer (aOC). (ASCO 2025) - P3 | "Clinical Trial Registration Number: NCT03602859 Background: The FIRST/ENGOT-OV44 trial evaluated adding dost, a programmed cell death protein-1 inhibitor, to 1L platinum-based chemotherapy (PBCT) and nira maintenance (MT) ± bevacizumab (bev) in patients (pts) with aOC. Adding dost to 1L PBCT and nira MT ± bev improved PFS in pts with aOC. No OS difference was observed."

Clinical • IO biomarker • Late-breaking abstract • Metastases • P3 data • Oncology • Ovarian Cancer • Solid Tumor • BRCA • HRD • PD-L1

The PULMO-01 phase I/IIa study of roginolisib in combination with dostarlimab, with or without docetaxel, in patients with advanced non-squamous NSCLC who have progressed on standard of care therapy (ELCC 2026) - P1/2 | "Secondary endpoints include evaluation of blood immune cell subsets such as naive, activated, memory and exhausted CD8+ and CD4+ T cells, B cells, NK cells, dendritic cells, monocytes and granulocytes, and to determine the PFS, ORR, and OS. Enrolment started in April 2025 and was completed in December 2025."

Clinical • Combination therapy • IO biomarker • Metastases • P1/2 data • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Solid Tumor • CD4 • CD8

Pembrolizumab lenvatinib in metastatic uterine carcinosarcoma cohort : safety and efficacy from the french multicenter early access program subgroup (LARENA study) (ESGO 2026) - P2/3 | "Introduction/Background Uterine carcinosarcoma (UCS) is a rare and aggressive histological subtype of endometrial cancer, characterized by poor prognosis and limited response to chemotherapy. No specific safety signal was observed. Alternative studies with PARP inhibitor and immunotherapy are ongoing, including a phase II/III ROCSAN comparing dostarlimab–niraparib, niraparib alone, and chemotherapy in mUCS (NCT 03651206)."

Clinical • IO biomarker • Metastases • Carcinosarcoma • Endometrial Cancer • Microsatellite Instability • Oncology • Sarcoma • Solid Tumor • Uterine Cancer • MSI • TP53

Disproportionality analysis of triple M (3M) syndrome associated with PD-1 inhibitors (ESMO-TAT 2026) - "This study evaluates the association between PD-1 inhibitors and 3M toxicities using U.S. Food and Drug Administration's Adverse Event Reporting System (FAERS). We conducted a retrospective pharmacovigilance analysis of FAERS quarterly datasets from 2014 Q1 to 2024 Q1, identifying reports involving pembrolizumab, nivolumab, cemiplimab, and dostarlimab. Although FAERS cannot confirm true clinical diagnoses, 3M toxicities accounted for 2.7% of PD-1–related reports and revealed strong signals, particularly for pembrolizumab in the full 3M overlap. These findings emphasize the need for early recognition and multidisciplinary management of neuromuscular and cardiac immune toxicities in patients receiving PD-1 inhibitors."

Genito-urinary Cancer • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor

Cost effectiveness analysis of immunotherapy regimens currently approved in advanced or recurrent endometrial cancer: An analysis of the NRG-GY 018, RUBY, and DUO-E trials. (PubMed, Gynecol Oncol Rep) - "The addition of pembrolizumab, dostarlimab, or durvalumab to chemotherapy in patients with dMMR tumors resulted in improvements in progression free life years saved. This appears to largely be driven by differences in duration of maintenance therapy rather than differences in effectiveness or individual drug cost. Immunotherapy does not appear to be as cost effective in the pMMR population."

dMMR • HEOR • Journal • pMMR • Endometrial Cancer • Oncology • Solid Tumor

Post-hoc survival outcomes based on initial and subsequent treatment in patients with mmrp/MSS primary advanced or recurrent endometrial cancer in the ENGOT-EN6-NSGO/GOG-3031/RUBY trial (ESGO 2026) - P3 | "Introduction/Background Dostarlimab+carboplatin-paclitaxel (CP) is the only immunotherapy+chemotherapy (CT) combination to report significant OS benefits in patients with primary advanced or recurrent endometrial cancer (pA/R EC) as shown in Part 1 of the phase 3 RUBY trial (NCT03981796)...At 22Sep2023 data cutoff, efficacy analyses were conducted for patients in the MMRp/MSS population who received either pembrolizumab+lenvatinib (pem/len; most common immunotherapy) or CT (most common FUACT) as FUACT...Patients in the dostarlimab+CP arm who received first FUACT of CT had more favourable survival outcomes than those in the placebo+CP arm who received first FUACT of CT or patients who received first FUACT of pem/len.Conclusion In the difficult-to-treat MMRp/MSS population, among patients who received pem/len or CT as first FUACT, OS favoured patients receiving initial systemic therapy with dostarlimab+CP versus placebo+CP. These findings support that dostarlimab+CP..."

Clinical • Metastases • Retrospective data • Endometrial Cancer • Oncology • Solid Tumor

ASSESSING DISTRIBUTION OF SOCIAL AND PRIVATE VALUE CREATION BY DRUGS REGULATING PROGRAMMED CELL DEATH-1IN CANCER TREATMENT... (ISPOR 2026) - "Pembrolizumab generated a positive net health value ($14.3B), as did cemiplimab ($.86B) and dostarlimab ($.03B). Negative net health value was generated by nivolumab (-$5.1B), atezolivumab (-$4.4B), avelumab (-$.064B), and durvalumab (-$5.9B). PD-1 drugs created substantial social and private value, with evident variation by drug indication and lifecycle. These findings provide a basis for assessing the return on both public and private investments and evidence-based policy regarding drug pricing and innovation."

Oncology

Heterogeneity in tumor microenvironment across MMR subtypes of endometrial cancer: Analysis from the ENGOT-EN6-NSGO/GOG-3031/RUBY trial (AACR 2026) - P3 | "Background: In RUBY Part 1 (NCT03981796), dostarlimab + carboplatin-paclitaxel (D+CP) significantly improved PFS and OS vs CP alone in pts with primary advanced or recurrent endometrial cancer (EC). These results highlight the molecular and transcriptomic heterogeneity of EC, providing hypotheses to explore the impact of tumor characteristics beyond MMR status on response to dostarlimab+CP in EC. Exploration of the association between these biomarkers and outcomes is ongoing."

Biomarker • Heterogeneity • Tumor microenvironment • Tumor mutational burden • Endometrial Cancer • Oncology • Solid Tumor • ARID1A • JAK1 • PIK3CA • PTEN • RNF43 • TMB • TP53

Peripheral immune signature of dostarlimab in addition to standard of care definitive radiation in patients with medically inoperable endometrial cancer (AACR 2026) - "At 6-week post-treatment, cytokines elevated from baseline persisted in patients treated with BT+EBRT while less variations in cytokine profiles were observed in the group without EBRT. Lastly, we observed a sustained decrease in PD-1+ T cells after 1 cycle of dostarlimab but an increased frequency of LAG-3+ or Tim-3+ T cells at cycle 2 and 3 of dostarlimab with RT.Taken together, the circulating immune profile demonstrated an association between the baseline and on-treatment immune activation signature with dostarlimab in addition to RT, highlighting the potential of this combination regimen to enhance therapeutic efficacy in patients with inoperable endometrial cancer."

Clinical • IO biomarker • Endometrial Cancer • Oncology • Solid Tumor • CCL2 • CD38 • CD4 • CD8 • CXCL10 • CXCL11 • CXCL13 • CXCL9 • GZMB • HAVCR2 • IL10 • IL15 • IL2 • IL21 • IL4 • ITGAX • LAG3 • PD-1

A phase 1B investigator-initiated trial of niraparib lead-in, followed by niraparib plus dostarlimab for metastatic BRCA1/2-mutated breast, tubo-ovarian, and pancreatic cancers (AACR 2026) - "Abstract is embargoed at this time."

Metastases • P1 data • Oncology • Ovarian Cancer • Pancreatic Cancer • Solid Tumor • BRCA1 • BRCA2

Real-World Evidence for 10 Oncology Drugs Approved in the last 5 years: A Comprehensive Narrative Synthesis. (PubMed, Crit Rev Oncol Hematol) - "RWE confirms the effectiveness and safety of multiple recently approved oncology drugs reinforcing the external validity of RCTs."

HEOR • Journal • Real-world evidence • Review • Breast Cancer • Endometrial Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Lung Cancer • Microsatellite Instability • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Urothelial Cancer • ER • HER-2 • MSI

ISS XVI: Navigating the Winds of Progress: Plotting a Course for Immunotherapy in Endometrial Cancer (SGO 2026) - "Sponsored by GSK. Description: Evaluate the clinical outcomes of dostarlimab and chemotherapy followed by dostarlimab maintenance in the mismatch repair deficient (dMMR) primary advanced or recurrent endometrial cancer (EC) population, including long-term survival and safety Explore data supporting the use of immunotherapy and chemotherapy in patients with mismatch repair proficient (MMRp) primary advanced or recurrent EC Discuss the timing and patterns of immune related adverse events (irAEs) of dostarlimab and review management strategies"

Endometrial Cancer • Oncology • Solid Tumor

Myasthenia Gravis (MG) Crisis, A Rare Immune-Related Adverse Event (irAE) of Dostarlimab (SCCM 2026) - "She received IV immunoglobulins (IVIG) , oral pyridostigmine, and IV methylprednisolone...She had the classic triad of MG, myositis, and myocarditis as an emerging ICI toxicity, received high- dose steroid, transitioned to prednisone with taper, and received atovaquone for prophylaxis...Current IVIG and rituximab guidelines recommend against initiating plasmapheresis shortly after administering rituximab; however, literature on the optimal sequence and timing is limited. Early recognition will change the management plan so IVIG and high-dose steroids can be started as soon as thecondition is recognized."

Adverse events • Cardiovascular • CNS Disorders • Endometrial Cancer • Immunology • Myasthenia Gravis • Myositis • Pulmonary Disease • Respiratory Diseases • Solid Tumor • Uterine Cancer

ISS XII: A Treatment Option for Patients With Primary Advanced or Recurrent Endometrial Cancer (SGO 2026) - "Sponsored by GSK. Description: Endometrial Cancer Background Review the incidence of endometrial cancer and the importance of MMR/MSI biomarker testing RUBY Part 1 Trial Results Learn about the efficacy and safety data for JEMPERLI in combination with carboplatin and paclitaxel followed by JEMPERLI as a single agent for primary advanced or recurrent endometrial cancer from the RUBY Part 1 trial Important Safety Information Review the Important Safety Information for JEMPERLI Summary"

Clinical • Metastases • Endometrial Cancer • Oncology • Solid Tumor

Combination PP2A inhibition and PD-1 blockade with LB-100 and dostarlimab in ovarian clear cell carcinoma (SGO 2026) - No abstract available

Late-breaking abstract • Clear Cell Carcinoma • Oncology • Ovarian Cancer

Four-year survival outcomes with dostarlimab plus chemotherapy in dMMR/MSI-H primary advanced or recurrent endometrial cancer in the ENGOT-EN6-NSGO/GOG-3031/RUBY trial (SGO 2026) - No abstract available

dMMR • Metastases • MSI-H • Endometrial Cancer • Microsatellite Instability • Oncology • Solid Tumor • MSI

A Phase Ib/II Single Arm Study of Cabozantinib Plus Dostarlimab in Women with Recurrent Gynecologic Carcinosarcoma (SGO 2026) - No abstract available

Clinical • P1/2 data • Carcinosarcoma • Oncology • Sarcoma • Solid Tumor

Profiling the Immune Repertoire in a Phase II Trial of Niraparib and Dostarlimab in Recurrent or Persistent Uterine Serous Carcinomas (SGO 2026) - No abstract available

P2 data • Endometrial Serous Adenocarcinoma • Oncology • Uterine Cancer