Dostarlimab Evidence: Trial Results and Peer-Reviewed Publications

Hipa.ai Research · Source: PubMed & ClinicalTrials.gov / AACT · Last updated:

The clinical evidence base for Dostarlimab comprises 80 peer-reviewed publications across 15 journals, 1 pivotal-trial primary-outcome rows reported to ClinicalTrials.gov, spanning indications including Neoplasms, Rectal Neoplasms, Endometrial Neoplasms, and Carcinoma, Non-Small-Cell Lung. Most recent publication: Longitudinal DCE MRI Vascular Textures: Radiologic and Biologic Insights for pCR Prediction in HER2-Negative Breast Cancer., Radiol Artif Intell, 2026.

Top peer-reviewed publications

Curated set of pivotal-trial result papers and recent publications in high-tier journals.

  1. Locally advanced breast cancers are more likely to present as Interval Cancers: results from the I-SPY 1 TRIAL (CALGB 150007/150012, ACRIN 6657, InterSPORE Trial).
    Lin C, Buxton MB, Moore D, et al. · Breast Cancer Res Treat · 2012
    PubMed: PMID 21796368 · NCT01042379 (I-SPY) · Neoplasms
  2. Locally advanced breast cancer: MR imaging for prediction of response to neoadjuvant chemotherapy--results from ACRIN 6657/I-SPY TRIAL.
    Hylton NM, Blume JD, Bernreuter WK, et al. · Radiology · 2012
    PubMed: PMID 22623692 · NCT01042379 (I-SPY) · Neoplasms
  3. Pathologic complete response predicts recurrence-free survival more effectively by cancer subset: results from the I-SPY 1 TRIAL--CALGB 150007/150012, ACRIN 6657.
    Esserman LJ, Berry DA, DeMichele A, et al. · J Clin Oncol · 2012
    PubMed: PMID 22649152 · NCT01042379 (I-SPY) · Neoplasms
  4. Chemotherapy response and recurrence-free survival in neoadjuvant breast cancer depends on biomarker profiles: results from the I-SPY 1 TRIAL (CALGB 150007/150012; ACRIN 6657).
    Esserman LJ, Berry DA, Cheang MC, et al. · Breast Cancer Res Treat · 2012
    PubMed: PMID 22198468 · NCT01042379 (I-SPY) · Neoplasms
  5. Datopotamab-deruxtecan plus durvalumab in early-stage breast cancer: the sequential multiple assignment randomized I-SPY2.2 phase 2 trial.
    Shatsky RA, Trivedi MS, Yau C, et al. · Nat Med · 2024
    PubMed: PMID 39277672 · NCT01042379 (I-SPY) · Neoplasms
  6. Datopotamab-deruxtecan in early-stage breast cancer: the sequential multiple assignment randomized I-SPY2.2 phase 2 trial.
    Khoury K, Meisel JL, Yau C, et al. · Nat Med · 2024
    PubMed: PMID 39277671 · NCT01042379 (I-SPY) · Neoplasms
  7. Nonoperative Management of Mismatch Repair-Deficient Tumors.
    Cercek A, Foote MB, Rousseau B, et al. · N Engl J Med · 2025
    PubMed: PMID 40293177 · NCT04165772 · Rectal Neoplasms
  8. Antitumor Activity and Safety of Dostarlimab Monotherapy in Patients With Mismatch Repair Deficient Solid Tumors: A Nonrandomized Controlled Trial.
    André T, Berton D, Curigliano G, et al. · JAMA Netw Open · 2023
    PubMed: PMID 37917058 · NCT02715284 (GARNET) · Neoplasms

Primary-outcome results across pivotal trials

Per-arm reported values from Phase 2/3 and Phase 3 trials with results posted to ClinicalTrials.gov.

TrialIndicationPrimary endpointArmValue
NCT03602859
FIRST
Ovarian NeoplasmsProgression Free Survival (PFS)
Up to approximately 316 weeks
Paclitaxel + Carboplatin + Dostarlimab +/- Bev, Then Niraparib+Dostarlimab +/- Bev (Arm3)20.63 Months
Paclitaxel + Carboplatin + Dostarlimab Pbo +/- Bev, Then Niraparib+Dostarlimab Pbo +/- Bev (Arm2)19.19 Months

Publications by year

2009–2026: 80 publications.

2009
1
2011
1
2012
4
2016
2
2018
1
2021
10
2022
14
2023
18
2024
8
2025
16
2026
5

Publications by indication

Neoplasms (58)

  • Longitudinal DCE MRI Vascular Textures: Radiologic and Biologic Insights for pCR Prediction in HER2-Negative Breast Cancer.
    Radiol Artif Intell · 2026 · PMID 41879562 · NCT01042379
  • Safety and efficacy of HSP90 inhibitor ganetespib for neoadjuvant treatment of stage II/III breast cancer.
    NPJ Breast Cancer · 2026 · PMID 36456573 · NCT01042379
  • Detection of serum HER2 in patients treated with neratinib or trastuzumab: analysis of the I-SPY Trial.
    Front Oncol · 2026 · PMID 40777112 · NCT01042379
  • Immune Subtyping Identifies Patients With Hormone Receptor-Positive Early-Stage Breast Cancer Who Respond to Neoadjuvant Immunotherapy (IO): Results From Five IO Arms of the I-SPY2 Trial.
    JCO Precis Oncol · 2025 · PMID 40526879 · NCT01042379
  • Patient-reported outcomes in the subpopulation of patients with mismatch repair-deficient/microsatellite instability-high primary advanced or recurrent endometrial cancer treated with dostarlimab plus chemotherapy compared with chemotherapy alone in the ENGOT-EN6-NSGO/GOG3031/RUBY trial.
    Int J Gynecol Cancer · 2025 · PMID 39322611 · NCT03981796

Rectal Neoplasms (5)

  • Nonoperative Management of Mismatch Repair-Deficient Tumors.
    N Engl J Med · 2025 · PMID 40293177 · NCT04165772
  • Immunotherapies in non-metastatic gastrointestinal cancers.
    Curr Opin Oncol · 2023 · PMID 37222204 · NCT04165772
  • Dostarlimab: A Review.
    Biomolecules · 2022 · PMID 35892341 · NCT04165772
  • PD-1 Blockade in Mismatch Repair-Deficient, Locally Advanced Rectal Cancer.
    N Engl J Med · 2022 · PMID 35660797 · NCT04165772
  • Combination Therapy with Radiation and PARP Inhibition Enhances Responsiveness to Anti-PD-1 Therapy in Colorectal Tumor Models.
    Int J Radiat Oncol Biol Phys · 2021 · PMID 32036006 · NCT04926324

Endometrial Neoplasms (4)

  • Molecular Characterization and Clinical Implications of Endometrial Cancer.
    Obstet Gynecol · 2025 · PMID 40966692 · NCT05201547
  • Phase 2b, open-label, single-arm, multicenter pilot study of the efficacy, safety, and tolerability of dostarlimab in women with early-stage mismatch repair-deficient endometrioid endometrial adenocarcinoma.
    Int J Gynecol Cancer · 2025 · PMID 39955187 · NCT06278857
  • Phase II randomized study of dostarlimab alone or with bevacizumab versus non-platinum chemotherapy in recurrent gynecological clear cell carcinoma (DOVE/APGOT-OV7/ENGOT-ov80).
    J Gynecol Oncol · 2025 · PMID 39710508 · NCT06023862
  • DOMENICA: dostarlimab versus chemotherapy alone in first-line MMR-deficient advanced endometrial cancer patients.
    Future Oncol · 2025 · PMID 40323277 · NCT05201547

Carcinoma, Non-Small-Cell Lung (3)

  • Long-term Survival Analysis From PERLA, A Phase II Randomized Trial of Dostarlimab With Chemotherapy Versus Pembrolizumab With Chemotherapy in Metastatic Nonsquamous NSCLC.
    JTO Clin Res Rep · 2025 · PMID 41080090 · NCT04581824
  • Dostarlimab or pembrolizumab plus chemotherapy in previously untreated metastatic non-squamous non-small cell lung cancer: the randomized PERLA phase II trial.
    Nat Commun · 2023 · PMID 37951954 · NCT04581824
  • Comparative analysis of PD-1 target engagement of dostarlimab and pembrolizumab in advanced solid tumors using ex vivo IL-2 stimulation data.
    CPT Pharmacometrics Syst Pharmacol · 2023 · PMID 36317409 · NCT04581824

Ovarian Neoplasms (2)

  • Niraparib and dostarlimab for the treatment of recurrent platinum-resistant ovarian cancer: results of a Phase II study (MOONSTONE/GOG-3032).
    Gynecol Oncol · 2023 · PMID 37890345 · NCT03955471
  • Randomized phase III trial on niraparib-TSR-042 (dostarlimab) versus physician's choice chemotherapy in recurrent ovarian, fallopian tube, or primary peritoneal cancer patients not candidate for platinum retreatment: NItCHE trial (MITO 33).
    Int J Gynecol Cancer · 2022 · PMID 34607820 · NCT04679064

Multiple Myeloma (2)

  • Belantamab mafodotin in combination with novel agents in relapsed/refractory multiple myeloma: DREAMM-5 study design.
    Future Oncol · 2021 · PMID 33682447 · NCT04126200
  • Antibody-Based Treatment Approaches in Multiple Myeloma.
    Curr Hematol Malig Rep · 2021 · PMID 33730360 · NCT04126200

Publications by journal

Trial-results highlights

The clinical evidence for Dostarlimab includes results from studies in ovarian neoplasms. In the NCT03602859 (FIRST) study, which investigated progression-free survival (PFS) for up to approximately 316 weeks, specific outcomes were reported for different treatment arms. For patients in the arm receiving Paclitaxel + Carboplatin + Dostarlimab +/- Bev, followed by Niraparib + Dostarlimab +/- Bev (Arm 3), the median progression-free survival was 20.63 Months. In comparison, for patients in the arm receiving Paclitaxel + Carboplatin + Dostarlimab Pbo +/- Bev, followed by Niraparib + Dostarlimab Pbo +/- Bev (Arm 2), the median progression-free survival was 19.19 Months.

All values presented here are sourced from primary registry reporting. For clinical decision-making, individual published papers and detailed study reports should be consulted.

All Dostarlimab publications (80)

2026 (5 papers)

  1. Longitudinal DCE MRI Vascular Textures: Radiologic and Biologic Insights for pCR Prediction in HER2-Negative Breast Cancer.
    Teng X, Ma J, Zhang J, et al. · Radiol Artif Intell · 2026 · Derived
    PubMed: PMID 41879562 · NCT01042379 (I-SPY) · Neoplasms
  2. A Phase III study of perioperative dostarlimab in patients with dMMR/MSI-H resectable colon cancer: AZUR-2 study design.
    Starling N, Elez E, Strickler JH, et al. · Future Oncol · 2026 · Derived
    PubMed: PMID 41492912 · NCT05855200 · Colonic Neoplasms
  3. JADE: phase 3 study of sequential dostarlimab post chemoradiotherapy in patients with locally advanced unresected HNSCC.
    Siu LL, Burtness B, Harrington K, et al. · Future Oncol · 2026 · Derived
    PubMed: PMID 41612885 · NCT06256588 (JADE) · Head and Neck Neoplasms
  4. Safety and efficacy of HSP90 inhibitor ganetespib for neoadjuvant treatment of stage II/III breast cancer.
    Lang JE, Forero-Torres A, Yee D, et al. · NPJ Breast Cancer · 2026 · Derived
    PubMed: PMID 36456573 · NCT01042379 (I-SPY) · Neoplasms
  5. Detection of serum HER2 in patients treated with neratinib or trastuzumab: analysis of the I-SPY Trial.
    Hensley M, Lengfeld J, Stoesz S, et al. · Front Oncol · 2026 · Derived
    PubMed: PMID 40777112 · NCT01042379 (I-SPY) · Neoplasms

2025 (16 papers)

  1. Immune Subtyping Identifies Patients With Hormone Receptor-Positive Early-Stage Breast Cancer Who Respond to Neoadjuvant Immunotherapy (IO): Results From Five IO Arms of the I-SPY2 Trial.
    Wolf DM, Yau C, Campbell M, et al. · JCO Precis Oncol · 2025 · Derived
    PubMed: PMID 40526879 · NCT01042379 (I-SPY) · Neoplasms
  2. Patient-reported outcomes in the subpopulation of patients with mismatch repair-deficient/microsatellite instability-high primary advanced or recurrent endometrial cancer treated with dostarlimab plus chemotherapy compared with chemotherapy alone in the ENGOT-EN6-NSGO/GOG3031/RUBY trial.
    Valabrega G, Powell MA, Hietanen S, et al. · Int J Gynecol Cancer · 2025 · Derived
    PubMed: PMID 39322611 · NCT03981796 (RUBY) · Neoplasms
  3. Molecular Characterization and Clinical Implications of Endometrial Cancer.
    Secord AA, Powell MA, McAlpine J, et al. · Obstet Gynecol · 2025 · Derived
    PubMed: PMID 40966692 · NCT05201547 (DOMENICA) · Endometrial Neoplasms
  4. Pexidartinib and standard neoadjuvant therapy in the adaptively randomized I-SPY2 trial for early breast cancer.
    Rugo HS, Campbell M, Yau C, et al. · Breast Cancer Res Treat · 2025 · Derived
    PubMed: PMID 39625569 · NCT01042379 (I-SPY) · Neoplasms
  5. Phase 2b, open-label, single-arm, multicenter pilot study of the efficacy, safety, and tolerability of dostarlimab in women with early-stage mismatch repair-deficient endometrioid endometrial adenocarcinoma.
    Obermair A, Gebski V, Goh J, et al. · Int J Gynecol Cancer · 2025 · Derived
    PubMed: PMID 39955187 · NCT06278857 (SATELLITE) · Endometrial Neoplasms
  6. A Plain Language Summary of "Dostarlimab for primary advanced or recurrent endometrial cancer".
    Mirza MR, Chase DM, Slomovitz BM, et al. · Future Oncol · 2025 · Derived
    PubMed: PMID 38990090 · NCT03981796 (RUBY) · Neoplasms
  7. Long-term Survival Analysis From PERLA, A Phase II Randomized Trial of Dostarlimab With Chemotherapy Versus Pembrolizumab With Chemotherapy in Metastatic Nonsquamous NSCLC.
    Lim SM, Ortega Granados AL, Pinto GDJ, et al. · JTO Clin Res Rep · 2025 · Derived
    PubMed: PMID 41080090 · NCT04581824 · Carcinoma, Non-Small-Cell Lung
  8. Combined prognostic impact of initial clinical stage and residual cancer burden after neoadjuvant systemic therapy in triple-negative and HER2-positive breast cancer: an analysis of the I-SPY2 randomized clinical trial.
    Leon-Ferre RA, Dimitroff K, Yau C, et al. · Breast Cancer Res · 2025 · Derived
    PubMed: PMID 40551254 · NCT01042379 (I-SPY) · Neoplasms
  9. Phase II randomized study of dostarlimab alone or with bevacizumab versus non-platinum chemotherapy in recurrent gynecological clear cell carcinoma (DOVE/APGOT-OV7/ENGOT-ov80).
    Lee JY, Tan D, Ray-Coquard I, et al. · J Gynecol Oncol · 2025 · Derived
    PubMed: PMID 39710508 · NCT06023862 (DOVE) · Endometrial Neoplasms
  10. A two-stage dual-task learning strategy for early prediction of pathological complete response to neoadjuvant chemotherapy for breast cancer using dynamic contrast-enhanced magnetic resonance images.
    Jing B, Wang J · Phys Med Biol · 2025 · Derived
    PubMed: PMID 40639409 · NCT01042379 (I-SPY) · Neoplasms
  11. CITRINO: phase 1 dose escalation study of anti-LAG-3 antibody encelimab alone or in combination with anti-PD-1 dostarlimab in patients with advanced/metastatic solid tumours.
    Hecht JR, Michot JM, Bajor D, et al. · BJC Rep · 2025 · Derived
    PubMed: PMID 40016550 · NCT03250832 (CITRINO) · Neoplasms
  12. Phase 2 study of dostarlimab plus niraparib in stage III-IV recurrent or refractory Penile squamous cell carcinoma.
    Hatoum F, Souza GR, Johnson J, et al. · Future Oncol · 2025 · Derived
    PubMed: PMID 41163621 · NCT05526989 · Penile Neoplasms
  13. Radiomics-based Machine Learning Prediction of Neoadjuvant Chemotherapy Response in Breast Cancer Using Physiologically Decomposed Diffusion-weighted MRI.
    Gilad M, Partridge SC, Iima M, et al. · Radiol Imaging Cancer · 2025 · Derived
    PubMed: PMID 40679371 · NCT01042379 (I-SPY) · Neoplasms
  14. DOMENICA: dostarlimab versus chemotherapy alone in first-line MMR-deficient advanced endometrial cancer patients.
    Cherifi F, Ray-Coquard I, Rubio MJ, et al. · Future Oncol · 2025 · Derived
    PubMed: PMID 40323277 · NCT05201547 (DOMENICA) · Endometrial Neoplasms
  15. Nonoperative Management of Mismatch Repair-Deficient Tumors.
    Cercek A, Foote MB, Rousseau B, et al. · N Engl J Med · 2025 · Derived
    PubMed: PMID 40293177 · NCT04165772 · Rectal Neoplasms
  16. Patient-reported outcomes in the GARNET trial in patients with advanced or recurrent mismatch repair-deficient/microsatellite instability-high endometrial cancer treated with dostarlimab.
    Kristeleit R, Mathews C, Redondo A, et al. · Int J Gynecol Cancer · 2025 · Background
    PubMed: PMID 35973737 · NCT02715284 (GARNET) · Neoplasms

2024 (8 papers)

  1. Circulating tumor DNA: from discovery to clinical application in breast cancer.
    Xu J, Gao H, Guan X, et al. · Front Immunol · 2024 · Derived
    PubMed: PMID 38745646 · NCT01042379 (I-SPY) · Neoplasms
  2. Datopotamab-deruxtecan plus durvalumab in early-stage breast cancer: the sequential multiple assignment randomized I-SPY2.2 phase 2 trial.
    Shatsky RA, Trivedi MS, Yau C, et al. · Nat Med · 2024 · Derived
    PubMed: PMID 39277672 · NCT01042379 (I-SPY) · Neoplasms
  3. Identification of HER2-positive breast cancer molecular subtypes with potential clinical implications in the ALTTO clinical trial.
    Rediti M, Venet D, Joaquin Garcia A, et al. · Nat Commun · 2024 · Derived
    PubMed: PMID 39613746 · NCT01042379 (I-SPY) · Neoplasms
  4. Implementation and impact of an electronic patient reported outcomes system in a phase II multi-site adaptive platform clinical trial for early-stage breast cancer.
    Northrop A, Christofferson A, Umashankar S, et al. · J Am Med Inform Assoc · 2024 · Derived
    PubMed: PMID 39158353 · NCT01042379 (I-SPY) · Neoplasms
  5. Breast Multiparametric MRI for Prediction of Neoadjuvant Chemotherapy Response in Breast Cancer: The BMMR2 Challenge.
    Li W, Partridge SC, Newitt DC, et al. · Radiol Imaging Cancer · 2024 · Derived
    PubMed: PMID 38180338 · NCT01042379 (I-SPY) · Neoplasms
  6. Datopotamab-deruxtecan in early-stage breast cancer: the sequential multiple assignment randomized I-SPY2.2 phase 2 trial.
    Khoury K, Meisel JL, Yau C, et al. · Nat Med · 2024 · Derived
    PubMed: PMID 39277671 · NCT01042379 (I-SPY) · Neoplasms
  7. Real-world patient characteristics and survival outcomes in patients with advanced or recurrent endometrial cancer in England: a retrospective, population-based study.
    Banerjee S, Ingles Russo Garces A, Garside J, et al. · BMJ Open · 2024 · Derived
    PubMed: PMID 39581729 · NCT03981796 (RUBY) · Neoplasms
  8. Safety of dostarlimab in combination with chemotherapy in patients with primary advanced or recurrent endometrial cancer in a phase III, randomized, placebo-controlled trial (ENGOT-EN6-NSGO/GOG-3031/RUBY).
    Auranen A, Powell MA, Sukhin V, et al. · Ther Adv Med Oncol · 2024 · Derived
    PubMed: PMID 39346117 · NCT03981796 (RUBY) · Neoplasms

2023 (18 papers)

  1. Cost-effectiveness analysis of dostarlimab plus carboplatin-paclitaxel as first-line treatment for advanced endometrial cancer.
    You M, Zeng X, Zhang J, et al. · Front Immunol · 2023 · Derived
    PubMed: PMID 37731489 · NCT03981796 (RUBY) · Neoplasms
  2. Activating Inducible T-cell Costimulator Yields Antitumor Activity Alone and in Combination with Anti-PD-1 Checkpoint Blockade.
    Yadavilli S, Waight JD, Brett S, et al. · Cancer Res Commun · 2023 · Derived
    PubMed: PMID 37593752 · NCT02723955 · Neoplasms
  3. Immunotherapies in non-metastatic gastrointestinal cancers.
    Saúde-Conde R, Nguyen D, Hendlisz A, et al. · Curr Opin Oncol · 2023 · Derived
    PubMed: PMID 37222204 · NCT04165772 · Rectal Neoplasms
  4. Real-world dostarlimab use in advanced/recurrent endometrial cancer in France.
    Rodrigues M, Eberst L, Follana P, et al. · Bull Cancer · 2023 · Derived
    PubMed: PMID 37659907 · NCT02715284 (GARNET) · Neoplasms
  5. Niraparib and dostarlimab for the treatment of recurrent platinum-resistant ovarian cancer: results of a Phase II study (MOONSTONE/GOG-3032).
    Randall LM, O'Malley DM, Monk BJ, et al. · Gynecol Oncol · 2023 · Derived
    PubMed: PMID 37890345 · NCT03955471 (MOONSTONE) · Ovarian Neoplasms
  6. Association of baseline ROR1 and ROR2 gene expression with clinical outcomes in the I-SPY2 neoadjuvant breast cancer trial.
    Parker BA, Shatsky RA, Schwab RB, et al. · Breast Cancer Res Treat · 2023 · Derived
    PubMed: PMID 37029329 · NCT01042379 (I-SPY) · Neoplasms
  7. Effect of Longitudinal Variation in Tumor Volume Estimation for MRI-guided Personalization of Breast Cancer Neoadjuvant Treatment.
    Onishi N, Bareng TJ, Gibbs J, et al. · Radiol Imaging Cancer · 2023 · Derived
    PubMed: PMID 37505107 · NCT01042379 (I-SPY) · Neoplasms
  8. Safety, Efficacy, and Biomarker Analyses of Dostarlimab in Patients with Endometrial Cancer: Interim Results of the Phase I GARNET Study.
    Oaknin A, Pothuri B, Gilbert L, et al. · Clin Cancer Res · 2023 · Derived
    PubMed: PMID 37363992 · NCT02715284 (GARNET) · Neoplasms
  9. Breast Conservation Surgery and Mastectomy Have Similar Locoregional Recurrence After Neoadjuvant Chemotherapy: Results From 1462 Patients on the Prospective, Randomized I-SPY2 Trial.
    Mukhtar RA, Chau H, Woriax H, et al. · Ann Surg · 2023 · Derived
    PubMed: PMID 37325931 · NCT01042379 (I-SPY) · Neoplasms
  10. Evaluation of Efficacy and Adverse Events After Second Immunotherapy Exposure in Endometrial and Cervical Carcinoma.
    Morton M, Marcu I, Levine M, et al. · Obstet Gynecol · 2023 · Derived
    PubMed: PMID 37411031 · NCT03981796 (RUBY) · Neoplasms
  11. Neoadjuvant treatment for stage III and IV cutaneous melanoma.
    Gorry C, McCullagh L, O'Donnell H, et al. · Cochrane Database Syst Rev · 2023 · Derived
    PubMed: PMID 36648215 · NCT04139902 · Melanoma
  12. Protein signaling and drug target activation signatures to guide therapy prioritization: Therapeutic resistance and sensitivity in the I-SPY 2 Trial.
    Gallagher RI, Wulfkuhle J, Wolf DM, et al. · Cell Rep Med · 2023 · Derived
    PubMed: PMID 38086377 · NCT01042379 (I-SPY) · Neoplasms
  13. Antitumor Activity and Safety of Dostarlimab Monotherapy in Patients With Mismatch Repair Deficient Solid Tumors: A Nonrandomized Controlled Trial.
    André T, Berton D, Curigliano G, et al. · JAMA Netw Open · 2023 · Derived
    PubMed: PMID 37917058 · NCT02715284 (GARNET) · Neoplasms
  14. Model-based meta-analysis of non-small cell lung cancer with standard of care PD-1 inhibitors and chemotherapy for early development decision making.
    Turner DC, Wada R, Zhou H, et al. · CPT Pharmacometrics Syst Pharmacol · 2023 · Background
    PubMed: PMID 36642813 · NCT02723955 · Neoplasms
  15. Dostarlimab for Primary Advanced or Recurrent Endometrial Cancer.
    Mirza MR, Chase DM, Slomovitz BM, et al. · N Engl J Med · 2023 · Background
    PubMed: PMID 36972026 · NCT03981796 (RUBY) · Neoplasms
  16. Dostarlimab or pembrolizumab plus chemotherapy in previously untreated metastatic non-squamous non-small cell lung cancer: the randomized PERLA phase II trial.
    Lim SM, Peters S, Ortega Granados AL, et al. · Nat Commun · 2023 · Background
    PubMed: PMID 37951954 · NCT04581824 · Carcinoma, Non-Small-Cell Lung
  17. Dostarlimab, an anti-programmed death-1 monoclonal antibody, does not cause QT prolongation in patients with solid tumours: A concentration-QT analysis.
    Kuchimanchi M, Dabrowski C, Lu S, et al. · Br J Clin Pharmacol · 2023 · Background
    PubMed: PMID 36823349 · NCT02715284 (GARNET) · Neoplasms
  18. Comparative analysis of PD-1 target engagement of dostarlimab and pembrolizumab in advanced solid tumors using ex vivo IL-2 stimulation data.
    Austin D, Melhem M, Gandhi Y, et al. · CPT Pharmacometrics Syst Pharmacol · 2023 · Background
    PubMed: PMID 36317409 · NCT04581824 · Carcinoma, Non-Small-Cell Lung

2022 (14 papers)

  1. Redefining breast cancer subtypes to guide treatment prioritization and maximize response: Predictive biomarkers across 10 cancer therapies.
    Wolf DM, Yau C, Wulfkuhle J, et al. · Cancer Cell · 2022 · Derived
    PubMed: PMID 35623341 · NCT01042379 (I-SPY) · Neoplasms
  2. Postneoadjuvant treatment for triple-negative breast cancer.
    Trapani D, Ferraro E, Giugliano F, et al. · Curr Opin Oncol · 2022 · Derived
    PubMed: PMID 35993306 · NCT01042379 (I-SPY) · Neoplasms
  3. Assessment of Residual Cancer Burden and Event-Free Survival in Neoadjuvant Treatment for High-risk Breast Cancer: An Analysis of Data From the I-SPY2 Randomized Clinical Trial.
    Symmans WF, Yau C, Chen YY, et al. · JAMA Oncol · 2022 · Derived
    PubMed: PMID 34529000 · NCT01042379 (I-SPY) · Neoplasms
  4. Association of Residual Ductal Carcinoma In Situ With Breast Cancer Recurrence in the Neoadjuvant I-SPY2 Trial.
    Osdoit M, Yau C, Symmans WF, et al. · JAMA Surg · 2022 · Derived
    PubMed: PMID 36069821 · NCT01042379 (I-SPY) · Neoplasms
  5. Clinical Activity and Safety of the Anti-Programmed Death 1 Monoclonal Antibody Dostarlimab for Patients With Recurrent or Advanced Mismatch Repair-Deficient Endometrial Cancer: A Nonrandomized Phase 1 Clinical Trial.
    Oaknin A, Tinker AV, Gilbert L, et al. · JAMA Oncol · 2022 · Derived
    PubMed: PMID 33001143 · NCT02715284 (GARNET) · Neoplasms
  6. Randomized phase III trial on niraparib-TSR-042 (dostarlimab) versus physician's choice chemotherapy in recurrent ovarian, fallopian tube, or primary peritoneal cancer patients not candidate for platinum retreatment: NItCHE trial (MITO 33).
    Musacchio L, Salutari V, Pignata S, et al. · Int J Gynecol Cancer · 2022 · Derived
    PubMed: PMID 34607820 · NCT04679064 (NItCHE-MITO33) · Ovarian Neoplasms
  7. Safety and Efficacy of Dostarlimab in Patients With Recurrent/Advanced Non-small Cell Lung Cancer: Results from Cohort E of the Phase I GARNET Trial.
    Moreno V, Roda D, Pikiel J, et al. · Clin Lung Cancer · 2022 · Derived
    PubMed: PMID 35729005 · NCT02715284 (GARNET) · Neoplasms
  8. Abemaciclib in patients with p16ink4A-deficient mesothelioma (MiST2): a single-arm, open-label, phase 2 trial.
    Fennell DA, King A, Mohammed S, et al. · Lancet Oncol · 2022 · Derived
    PubMed: PMID 35157829 · NCT03654833 (MiST) · Mesothelioma, Malignant
  9. Dostarlimab: A Review.
    Costa B, Vale N · Biomolecules · 2022 · Derived
    PubMed: PMID 35892341 · NCT04165772 · Rectal Neoplasms
  10. PD-1 Blockade in Mismatch Repair-Deficient, Locally Advanced Rectal Cancer.
    Cercek A, Lumish M, Sinopoli J, et al. · N Engl J Med · 2022 · Derived
    PubMed: PMID 35660797 · NCT04165772 · Rectal Neoplasms
  11. JASPER: Phase 2 trial of first-line niraparib plus pembrolizumab in patients with advanced non-small cell lung cancer.
    Ramalingam SS, Thara E, Awad MM, et al. · Cancer · 2022 · Background
    PubMed: PMID 34478166 · NCT03308942 · Neoplasms
  12. Safety, antitumor activity, and pharmacokinetics of dostarlimab, an anti-PD-1, in patients with advanced solid tumors: a dose-escalation phase 1 trial.
    Patnaik A, Weiss GJ, Rasco DW, et al. · Cancer Chemother Pharmacol · 2022 · Background
    PubMed: PMID 34750637 · NCT02715284 (GARNET) · Neoplasms
  13. Safety and antitumor activity of dostarlimab in patients with advanced or recurrent DNA mismatch repair deficient/microsatellite instability-high (dMMR/MSI-H) or proficient/stable (MMRp/MSS) endometrial cancer: interim results from GARNET-a phase I, single-arm study.
    Oaknin A, Gilbert L, Tinker AV, et al. · J Immunother Cancer · 2022 · Background
    PubMed: PMID 35064011 · NCT02715284 (GARNET) · Neoplasms
  14. Preclinical characterization of dostarlimab, a therapeutic anti-PD-1 antibody with potent activity to enhance immune function in in vitro cellular assays and in vivo animal models.
    Kumar S, Ghosh S, Sharma G, et al. · MAbs · 2022 · Background
    PubMed: PMID 34313545 · NCT02715284 (GARNET) · Neoplasms

2021 (10 papers)

  1. Atezolizumab in the treatment of metastatic triple-negative breast cancer.
    Pérez-García J, Soberino J, Racca F, et al. · Expert Opin Biol Ther · 2021 · Derived
    PubMed: PMID 32450725 · NCT01042379 (I-SPY) · Neoplasms
  2. Clinical activity and safety of the anti-PD-1 monoclonal antibody dostarlimab for patients with recurrent or advanced dMMR endometrial cancer.
    Oaknin A, Tinker AV, Gilbert L, et al. · Future Oncol · 2021 · Derived
    PubMed: PMID 34427115 · NCT02715284 (GARNET) · Neoplasms
  3. Belantamab mafodotin in combination with novel agents in relapsed/refractory multiple myeloma: DREAMM-5 study design.
    Nooka AK, Weisel K, van de Donk NW, et al. · Future Oncol · 2021 · Derived
    PubMed: PMID 33682447 · NCT04126200 (DREAMM 5) · Multiple Myeloma
  4. Effect of Pembrolizumab Plus Neoadjuvant Chemotherapy on Pathologic Complete Response in Women With Early-Stage Breast Cancer: An Analysis of the Ongoing Phase 2 Adaptively Randomized I-SPY2 Trial.
    Nanda R, Liu MC, Yau C, et al. · JAMA Oncol · 2021 · Derived
    PubMed: PMID 32053137 · NCT01042379 (I-SPY) · Neoplasms
  5. Association of Event-Free and Distant Recurrence-Free Survival With Individual-Level Pathologic Complete Response in Neoadjuvant Treatment of Stages 2 and 3 Breast Cancer: Three-Year Follow-up Analysis for the I-SPY2 Adaptively Randomized Clinical Trial.
    I-SPY2 Trial Consortium, Yee D, DeMichele AM, et al. · JAMA Oncol · 2021 · Derived
    PubMed: PMID 32701140 · NCT01042379 (I-SPY) · Neoplasms
  6. Antibody-Based Treatment Approaches in Multiple Myeloma.
    Hosoya H, Sidana S · Curr Hematol Malig Rep · 2021 · Derived
    PubMed: PMID 33730360 · NCT04126200 (DREAMM 5) · Multiple Myeloma
  7. Rucaparib in patients with BAP1-deficient or BRCA1-deficient mesothelioma (MiST1): an open-label, single-arm, phase 2a clinical trial.
    Fennell DA, King A, Mohammed S, et al. · Lancet Respir Med · 2021 · Derived
    PubMed: PMID 33515503 · NCT03654833 (MiST) · Mesothelioma, Malignant
  8. RAB5A expression is a predictive biomarker for trastuzumab emtansine in breast cancer.
    Engebraaten O, Yau C, Berg K, et al. · Nat Commun · 2021 · Derived
    PubMed: PMID 34741021 · NCT01042379 (I-SPY) · Neoplasms
  9. MK-2206 and Standard Neoadjuvant Chemotherapy Improves Response in Patients With Human Epidermal Growth Factor Receptor 2-Positive and/or Hormone Receptor-Negative Breast Cancers in the I-SPY 2 Trial.
    Chien AJ, Tripathy D, Albain KS, et al. · J Clin Oncol · 2021 · Derived
    PubMed: PMID 32031889 · NCT01042379 (I-SPY) · Neoplasms
  10. Combination Therapy with Radiation and PARP Inhibition Enhances Responsiveness to Anti-PD-1 Therapy in Colorectal Tumor Models.
    Seyedin SN, Hasibuzzaman MM, Pham V, et al. · Int J Radiat Oncol Biol Phys · 2021 · Background
    PubMed: PMID 32036006 · NCT04926324 · Rectal Neoplasms

2018 (1 paper)

  1. The BRCA1ness signature is associated significantly with response to PARP inhibitor treatment versus control in the I-SPY 2 randomized neoadjuvant setting.
    Severson TM, Wolf DM, Yau C, et al. · Breast Cancer Res · 2018 · Derived
    PubMed: PMID 28851423 · NCT01042379 (I-SPY) · Neoplasms

2016 (2 papers)

  1. Adaptive Randomization of Veliparib-Carboplatin Treatment in Breast Cancer.
    Rugo HS, Olopade OI, DeMichele A, et al. · N Engl J Med · 2016 · Derived
    PubMed: PMID 27406347 · NCT01042379 (I-SPY) · Neoplasms
  2. Adaptive Randomization of Neratinib in Early Breast Cancer.
    Park JW, Liu MC, Yee D, et al. · N Engl J Med · 2016 · Derived
    PubMed: PMID 27406346 · NCT01042379 (I-SPY) · Neoplasms

2012 (4 papers)

  1. Locally advanced breast cancers are more likely to present as Interval Cancers: results from the I-SPY 1 TRIAL (CALGB 150007/150012, ACRIN 6657, InterSPORE Trial).
    Lin C, Buxton MB, Moore D, et al. · Breast Cancer Res Treat · 2012 · Trial result
    PubMed: PMID 21796368 · NCT01042379 (I-SPY) · Neoplasms
  2. Locally advanced breast cancer: MR imaging for prediction of response to neoadjuvant chemotherapy--results from ACRIN 6657/I-SPY TRIAL.
    Hylton NM, Blume JD, Bernreuter WK, et al. · Radiology · 2012 · Trial result
    PubMed: PMID 22623692 · NCT01042379 (I-SPY) · Neoplasms
  3. Pathologic complete response predicts recurrence-free survival more effectively by cancer subset: results from the I-SPY 1 TRIAL--CALGB 150007/150012, ACRIN 6657.
    Esserman LJ, Berry DA, DeMichele A, et al. · J Clin Oncol · 2012 · Trial result
    PubMed: PMID 22649152 · NCT01042379 (I-SPY) · Neoplasms
  4. Chemotherapy response and recurrence-free survival in neoadjuvant breast cancer depends on biomarker profiles: results from the I-SPY 1 TRIAL (CALGB 150007/150012; ACRIN 6657).
    Esserman LJ, Berry DA, Cheang MC, et al. · Breast Cancer Res Treat · 2012 · Trial result
    PubMed: PMID 22198468 · NCT01042379 (I-SPY) · Neoplasms

2011 (1 paper)

  1. Accelerating identification and regulatory approval of investigational cancer drugs.
    Esserman LJ, Woodcock J · JAMA · 2011 · Background
    PubMed: PMID 22187281 · NCT01042379 (I-SPY) · Neoplasms

2009 (1 paper)

  1. I-SPY 2: an adaptive breast cancer trial design in the setting of neoadjuvant chemotherapy.
    Barker AD, Sigman CC, Kelloff GJ, et al. · Clin Pharmacol Ther · 2009 · Background
    PubMed: PMID 19440188 · NCT01042379 (I-SPY) · Neoplasms

Sources and methodology

This page summarizes published evidence for general reference and does not constitute medical advice. For clinical decisions, consult the linked primary publications and your healthcare provider. Data sourced from PubMed and the ClinicalTrials.gov / AACT database maintained by the Clinical Trials Transformation Initiative (CTTI).