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

Immunotherapy and Chemotherapy for Advanced or Recurrent Endometrial Carcinoma. (PubMed, Anticancer Res) - "Moreover, the follow-up data for dostarlimab extended beyond 44 months and the median overall survival (OS) has not been reached compared to more limited OS data for both pembrolizumab and durvalumab; additionally, dostarlimab's pronounced risk of disease progression or death in both dMMR (70%) and mismatch repair-proficient (pMMR) (46%) patients is considerable. While pembrolizumab, dostarlimab and durvalumab with chemotherapy are associated with beneficial outcomes in advanced-stage or recurrent endometrial cancer, dostarlimab has distinguished itself with unsurpassed survival data compared to pembrolizumab and durvalumab."

Journal • Review • Endometrial Cancer • Oncology • Solid Tumor

Precision medicine in colorectal cancer: Personalizing treatment for improved outcomes? (ESMO-GI 2025) - "Other MTT: KRAS G12C inhibitor + Cetuximab (N=18), pan-RAS inhibitor for KRAS G12Cm (N=1), Encorafenib + Cetuximab (N=14) and Dabrafenib + Trametinib (N=1) for BRAF V600Em, Trastuzumab Deruxtecan (N=3) and Tucatinib + Trastuzumab for HER2m/a (N=1), Trametinib for MEKm (N=2), anti LGR5-EGFR bispecific antibody for EGFRm (N=1), Niraparib + Dostarlimab for ARID1Am (N=1), Alectinib for ALKf(N=1) and Inavolisib for PIK3CAm (N=1). Despite no obvious OS benefit of MTT due to small pts number and late MTT lines, this study highlights the different potential targetable MA in 28.9% of pts excluding non G12C RASm. Impact of novel RAS inhibitors and other MTT might change mCRC precision medicine."

IO biomarker • Colorectal Cancer • Oncology • Solid Tumor • ALK • ARID1A • BRAF • KRAS

DOVIPA: A phase II study with safety run-in of mFOLFIRINOX, dostarlimab, and oral vitamin D in metastatic pancreatic cancer with translational research on resistance mechanisms (ESMO-GI 2025) - P2 | "Preclinical studies suggest vitamin D reduces stromal fibrosis and enhances immune response, while oxaliplatin induces immunogenic cell death, potentially synergizing with PD-1 blockade. Patients will be treated until progression or unacceptable toxicity. No randomization or control arm is planned in this exploratory study."

Clinical • IO biomarker • Metastases • P2 data • Oncology • Pancreatic Cancer • Solid Tumor

Combined Targeting of PD-1 and TIM-3 in Patients with Locally Advanced or Metastatic Non-Small Cell Lung Cancer: AMBER Part 2B. (PubMed, Clin Cancer Res) - P1 | "Cobolimab plus dostarlimab showed preliminary efficacy and tolerability in a subset of patients with locally advanced/metastatic NSCLC. See related article by Davar et al., p. XX."

IO biomarker • Journal • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • HAVCR2 • PD-1

Combined Targeting of PD-1 and TIM-3 in Patients with Locally Advanced or Metastatic Melanoma: AMBER Cohorts 1c, 1e, and 2A. (PubMed, Clin Cancer Res) - P1 | "In this exploratory setting, cobolimab plus dostarlimab was well tolerated, with reported preliminary efficacy similar to other anti-T-cell immunoglobulin and mucin-domain containing protein-3 treatments in patients with locally advanced/metastatic melanoma. See related article by Davar et al., p. XX."

Journal • Melanoma • Oncology • Solid Tumor • HAVCR2 • PD-1

“The pan-Canadian Oncology Drug Review Expert Review Committee (pERC) recommends that dostarlimab in combination with carboplatin-paclitaxel be reimbursed for treatment of adults with primary advanced or first recurrent endometrial cancer who are candidates for systemic therapy, if the conditions listed in are met.” (Ottawa (ON): Canadian Agency for Drugs and Technologies in Health)

Reimbursement • Endometrial Cancer • Gynecologic Cancers • Oncology

Time to next treatment by age subgroup in patients (pts) with primary advanced or recurrent endometrial cancer (pA/rEC) in the ENGOT-EN6-NSGO/GOG-3031/RUBY trial (ESMO-GC 2025) - P3 | "Background Dostarlimab + carboplatin-paclitaxel (DOST+CP) is the only immunotherapy + chemotherapy combination to report significant overall survival (OS) benefits vs placebo (PBO) + CP in pts with pA/rEC as shown in Part 1 of the phase III RUBY trial (NCT03981796). Editorial acknowledgement Writing and editorial support, funded and coordinated by GSK, was provided by Shannon Morgan-Pelosi, PhD, CMPP and Mary C. Wiggin, of Ashfield MedComms, an Inizio company. Legal entity responsible for the study GSK/ENGOT/NSGO/GOG."

Clinical • Metastases • Endometrial Cancer • Oncology • Solid Tumor

Understanding the impact of our medicines on quality of life for patients with gynaecologic cancers (GSK Press Release) - "Findings from GSK’s gynaecologic cancer portfolio focus on understanding the patient treatment experience....These include: (i) Results of the phase III FIRST-ENGOT-OV44 trial provides insight on the role of adding dostarlimab to platinum-based chemotherapy followed by niraparib maintenance, with or without bevacizumab, in first-line advanced ovarian cancer (ASCO abstract #LBA5506); (ii) Patient reported outcomes from the phase III PRIMA trial...will help inform healthcare providers on the impact of disease progression on quality of life in patients with newly diagnosed advanced ovarian cancer (ASCO abstract #5551); (iii) New post-hoc analysis from Part 1 of the phase III RUBY trial...evaluates time to changes in quality of life with dostarlimab plus chemotherapy (carboplatin-paclitaxel) compared to chemotherapy alone in patients with primary advanced or recurrent endometrial cancer (ASCO abstract #5600)."

P3 data • Patient reported outcomes • Endometrial Cancer • Ovarian 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

Dose Escalation and Cohort Expansion Study of Niraparib and Dostarlimab in Paediatric Participants With Solid Tumors (SCOOP) (clinicaltrials.gov) - P1 | N=47 | Terminated | Sponsor: GlaxoSmithKline | N=116 ➔ 47 | Trial completion date: May 2030 ➔ Apr 2025 | Recruiting ➔ Terminated | Trial primary completion date: Oct 2029 ➔ Apr 2025; The study was paused for enrolment to further assess clinical data

Enrollment change • Trial completion date • Trial primary completion date • Trial termination • Adrenal Cortex Carcinoma • Oncology • Pediatrics • Sarcoma • Solid Tumor • BRCA • BRCA1 • BRCA2 • TMB

Re-VOLVE: Phase II clinical trial in women with ovarian cancer progressing post-PARP inhibitor with treatment adapted to real-time assessment of evolving genomic resistance. (ASCO 2025) - P2 | "If progression/stable disease after IP pts were assigned to cohort A (niraparib/bevacizumab/dostarlimab 500mg) if no resistance mechanisms and to B (weekly paclitaxel 80mg/m2/bevacizumab/dostarlimab) if any present and to cohort C (continue niraparib/bevacizumab) if partial response after IP. These findings highlight the potential clinical activity of a chemo-free approach and confirmed the feasibility of guiding personalized therapy in real-time in recurrent OC pts post-PARPi. This strategy was safe and provided clinical benefit to some pts. Further translational analysis is ongoing."

Clinical • P2 data • Anemia • High Grade Serous Ovarian Cancer • Neutropenia • Oncology • Ovarian Cancer • Solid Tumor • Thrombocytopenia • BRCA • CCNE1 • CHEK2

Phase II Trial of the PARP Inhibitor Niraparib and PD-1 Inhibitor Dostarlimab in Patients With Advanced Cancers With Active Progressing Brain Metastases (STARLET) (clinicaltrials.gov) - P2 | N=120 | Recruiting | Sponsor: M.D. Anderson Cancer Center | Trial completion date: Aug 2027 ➔ Feb 2026 | Trial primary completion date: Aug 2025 ➔ Feb 2026

Trial completion date • Trial primary completion date • Non Small Cell Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor • Triple Negative Breast Cancer • BRIP1 • CDK12 • CHEK1 • CHEK2 • FANCL • HRD • PD-L1 • RAD51 • RAD51B • RAD51C • RAD51D • RAD52 • RAD54L

Dostarlimab/Chemo, Maintenance Niraparib Show Modest Improvements in Ovarian Cancer (Cancer Network) - P3 | N=1,402 | FIRST (NCT03602859) | Sponsor: Tesaro, Inc. | "First-line treatment with dostarlimab-gxly (Jemperli) plus platinum-based chemotherapy and maintenance niraparib (Zejula) demonstrated a statistically significant, though clinically modest, improvement in progression-free survival (PFS) and an expected safety profile in patients with newly diagnosed advanced ovarian cancer, based on results from the phase 3 FIRST/ENGOT-OV44 trial (NCT03602859) shared at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting...The median PFS with dostarlimab plus niraparib was 20.6 months (95% CI, 19.2-22.8) vs 19.2 months (95% CI, 16.6-21.0) with niraparib alone (HR, 0.85; 95% CI, 0.73-0.99; P = .0351); the 1-year PFS rates were 75% vs 70%, 2-year PFS rates were 44% vs 40%, and 3-year PFS rates were 32% vs 27%....the 1-year PFS rates were 78% vs 77%, 2-year PFS rates were 55% vs 51%, and 3-year PFS rates were 44% vs 41%."

P3 data • Ovarian Cancer

Dostarlimab and niraparib in primary advanced ovarian cancer. (PubMed, Ann Oncol) - "In the first-line treatment of patients with aOC, the addition of dostarlimab to PBCT and niraparib maintenance was associated with a statistically significant, but clinically modest, PFS improvement, with no difference in OS."

Clinical • Journal • Oncology • Ovarian Cancer • Solid Tumor

Industry Supported Symposium Luncheon: JEMPERLI: A Treatment Option for Patients With Primary Advanced or Recurrent Endometrial Cancer (GSK) (WAGO 2025) - "Activity Overview GSK welcomes gynecologic oncologists, oncologists, advanced practitioners (NP/PA/PharmD), and other clinicians who treat patients with gynecologic malignancies to attend the JEMPERLI: A Treatment Option for Patients With Primary Advanced or Recurrent Endometrial Cancer, an Industry Supported Symposium presented at the WAGO 2025 Annual Meeting on Thursday, June 19, 2025. This is a non-CME program and is intended for healthcare professionals only."

Clinical • Metastases • Endometrial Cancer • Gynecologic Cancers • Oncology • Solid Tumor

Important Safety Information (WAGO 2025) - "Supported by GSK. Review the Important Safety Information for JEMPERLI"

Clinical • Endometrial Cancer • Oncology • Solid Tumor

RUBY Part 1 Trial Results (WAGO 2025) - "Supported by GSK. Learn about the efficacy and safety data of 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"

Endometrial Cancer • Oncology • Solid Tumor

Dostarlimab Plus Cobolimab Improves MPR Rate vs Dostarlimab in High-Risk Resectable Melanoma (OncLive) - P2 | N=62 | NEO-MEL-T (NCT04139902) | "The addition of cobolimab to dostarlimab-gxly (Jemperli) was tolerable and led to efficacy improvements compared with dostarlimab monotherapy for the neoadjuvant treatment of patients with high-risk resectable melanoma, according to data from the phase 2 NEO-MEL-T trial (NCT04139902) presented during the 2025 ASCO Annual Meeting. Findings from the primary analysis of NEO-MEL-T demonstrated that patients who received the combination (n = 27) achieved a major pathological response (MPR) rate of 55.6% and those who received dostarlimab alone (n = 30) experienced an MPR rate of 33.3%. The pathological complete response rates were 37% and 33.3%, respectively. Additionally, 18.5% and 3.7% of patients in the combination arm experienced a pathological major response or a pathological partial response, respectively."

P2 data • Melanoma

Molecular testing in primary advanced or recurrent endometrial cancer: A cost-effectiveness analysis. (ASCO 2025) - P3 | "Patients in the no-testing arm were assigned to receive carboplatin-paclitaxel (CP), dostarlimab + CP, pembrolizumab + CP, or hormonal therapy (everolimus/letrozole). Patients in the ProMisE arm were assigned to the same treatments or bevacizumab + CP, according to their molecular profile... ProMisE testing is cost-effective vs no testing when using a $150,000/QALY-gained threshold. Given the heterogeneity of molecular subtypes in stage III/IV pA/rEC, molecular testing enables personalized treatment that is clinically meaningful and high value from payer and societal perspectives."

Cost effectiveness • HEOR • Metastases • Endometrial Cancer • Oncology • Solid Tumor • TP53

Pharmacovigilance study on the reporting frequency of atrial fibrillation with immune checkpoint inhibitors: insights from FDA Adverse Event Reporting System. (PubMed, Ther Adv Drug Saf) - "Cases reporting one or more ICIs (atezolizumab, avelumab, cemiplimab, dostarlimab, durvalumab, ipilimumab, nivolumab, pembrolizumab, and tremelimumab) and atrial fibrillation were selected. The anti-CTLA-4 showed a lower likelihood of reporting atrial fibrillation, while higher reporting was found with anti-PD-1 and anti-PD-L1. Further studies are needed to confirm this safety aspect."

Adverse events • Checkpoint inhibition • Journal • Atrial Fibrillation • Cardiovascular • Oncology

AZUR-4, a phase 2, open label, randomized study of neoadjuvant dostarlimab plus capecitabine plus oxaliplatin (CAPEOX) versus CAPEOX alone in previously untreated T4N0 or stage III mismatch repair proficient/microsatellite stable resectable colon cancer. (ASCO 2025) - P2 | "Secondary endpoints include primary tumor resection not being excluded by either disease progression or treatment-related toxicities, and pathological response categories that include complete pathological response (cPR) and partial pathologic response (pPR). Exploratory endpoints include overall survival, event-free survival, effects on circulating tumor DNA dynamics, and pathological response rate in biomarker subsets."

Clinical • IO biomarker • Mismatch repair • P2 data • pMMR • Colon Adenocarcinoma • Colon Cancer • Colorectal Adenocarcinoma • Colorectal Cancer • Microsatellite Instability • Oncology • Solid Tumor • MSI • PD-L2

NADIA: Clinical Trial to Assess the Efficacy of Dostarlimab as Neoadjuvant Therapy in Patients With MMRd/MSI-H Stage II-III Endometrial Cancer (clinicaltrials.gov) - P2 | N=25 | Not yet recruiting | Sponsor: Grupo Español de Investigación en Cáncer de Ovario

dMMR • MSI-H • New P2 trial • Endometrial Cancer • Microsatellite Instability • Oncology • Solid Tumor

PENELOPE: A randomized phase II trial of first-line carboplatin and paclitaxel in combination with pembrolizumab, followed by maintenance pembrolizumab with or without nesuparib, in patients with newly diagnosed advanced or recurrent MMR-proficient endometrial cancer. (ASCO 2025) - P2 | "Two landmark phase III RCTs, NRG-GY018 and RUBY, proved that the addition of pembrolizumab or dostarlimab to standard chemotherapy resulted in significantly longer progression-free survival (PFS) than with chemotherapy alone in patients with advanced or recurrent endometrial cancer...Although the phase III DUO-E trial demonstrated elongated PFS from paclitaxel/carboplatin plus durvalumab followed by maintenance durvalumab with or without olaparib in patients with advanced or recurrent endometrial cancer, this trial is not designed to prove that addition of olaparib maintenance provides extra survival benefits...Primary endpoint is investigator-assessed PFS (RECIST 1.1) of arm B vs. arm A, and key secondary endpoints are overall survival, overall response rate, disease control rate, duration of response, and safety. Enrollment began in Q4 2024."

Clinical • Combination therapy • Metastases • P2 data • Endometrial Cancer • Oncology • Solid Tumor

Cobolimab and dostarlimab in the first-line treatment of unresectable hepatoma: A multi-center, single arm, phase 2 trial. (ASCO 2025) - P2 | "Cobolimab plus dostarlimab yielded promising response rates and survival outcomes with acceptable safety as first-line treatment in patients with CP A, unresectable HCC. This represents a potential therapy regimen for this population. Clinical trial information: NCT03680508."

Clinical • P2 data • Endocrine Disorders • Hepatocellular Cancer • Liver Cancer • Solid Tumor

Time to subsequent therapy in patients (pts) with primary advanced or recurrent endometrial cancer (pA/rEC) receiving dostarlimab plus carboplatin-paclitaxel (DOST+CP) compared with pts receiving placebo plus CP (PBO+CP) in the ENGOT-EN6-NSGO/GOG-3031/RUBY trial. (ASCO 2025) - P3 | "These results indicate prolonged TFST and sustained benefits through TSST with DOST+CP compared with PBO+CP across the overall, dMMR/MSI-H, and MMRp/MSS populations in the RUBY trial. Together with the statistically significant PFS and OS benefits, these findings support the frontline use of dostarlimab + CP as a standard of care in all pts with pA/rEC. NR, not reached; TFST, time to first subsequent treatment; TSST, time to second subsequent treatment."

Clinical • Metastases • Endometrial Cancer • Oncology • Solid Tumor • MSI