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Oncology Pipeline

At GSK, our pipeline is focused on unlocking the science of the immune system, human genetics, and advanced technologies to develop vaccines and specialty medicines.

Our products in development progress through three stages: phase I, phase II, and phase III/registrational. Each of these phases allows us to assess the safety and efficacy of our investigational products to eventually provide data to support applications for regulatory approval.

Disease States

0 Results

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ENDOMETRIAL CANCER Phase 3

Dostarlimab | Anti–PD-1 antibody

RUBY: dostarlimab in combination with carboplatin-paclitaxel compared with placebo and carboplatin-paclitaxel in patients with primary advanced or first recurrent endometrial cancer

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GASTROINTESTINAL CANCER Phase 2

Dostarlimab | Anti–PD-1 antibody

AZUR-1: dostarlimab monotherapy in patients with untreated stage II/III dMMR/MSI-H locally advanced rectal cancer

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GASTROINTESTINAL CANCER Phase 3

Dostarlimab | Anti–PD-1 antibody

AZUR-2: dostarlimab perioperative monotherapy in patients with untreated T4N0 or stage III dMMR/MSI-H resectable colon cancer

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GLIOBLASTOMA Phase 3

Niraparib | PARP inhibitor

GLIOFOCUS: study comparing the clinical efficacy and safety of niraparib with temozolomide in adult participants with newly-diagnosed, MGMT unmethylated glioblastoma

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HEAD AND NECK CANCER Phase 2

Dostarlimab I Belrestotug I Nelistotug

GALAXIES H&N-202: study evaluating novel immunotherapy combinations as first-line treatment of PD-L1-positive, recurrent/metastatic HNSCC

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HEAD AND NECK CANCER Phase 3

Dostarlimab | Anti–PD-1 antibody

JADE: study to evaluate dostarlimab as sequential therapy after chemoradiation in participants with locally advanced unresected head and neck squamous cell carcinoma

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LUNG CANCER Phase 2

Belrestotug | Anti-TIGIT IgG1 antibody¶

ENTRÉE-Lung: platform trial of novel regimens versus standard of care in NSCLC

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NCT05565378: platform study utilizing a master protocol to evaluate novel immunotherapy combinations in patients with previously untreated, locally advanced unresectable or metastatic, PD-L1-selected non-small cell lung cancer

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Dostarlimab | Anti–PD-1 antibody

PERLA: dostarlimab with chemotherapy vs pembrolizumab with chemotherapy in metastatic nonsquamous NSCLC

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Nelistotug

GALAXIES-LUNG-201: platform study utilizing a master protocol to evaluate of novel immunotherapy combinations in patients with previously untreated, locally advanced unresectable/metastatic, PD-L1–selected NSCLC

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LUNG CANCER Phase 3

dostarlimab | Anti–PD-1 antibody

COSTAR Lung: cobolimab in combination with dostarlimab and docetaxel in advanced NSCLC that has progressed on prior anti-PD-(L)1 therapy and chemotherapy

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Niraparib | PARP inhibitor

ZEAL-1L: niraparib with pembrolizumab vs placebo with pembrolizumab as maintenance therapy in NSCLC

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Cobolimab | Anti–TIM-3 antibody

COSTAR Lung: cobolimab in combination with dostarlimab and docetaxel in advanced NSCLC that has progressed on prior anti-PD-(L)1 therapy and chemotherapy

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MULTIPLE MYELOMA Phase 1

Belantamab mafodotin | Anti-BCMA antibody‑drug conjugate*

DREAMM-5: platform study of belantamab mafodotin alone and in combination with GSK3174998 (OX40 agonist antibody), feladilimab (ICOS agonist IgG4 antibody), nirogacestat alone or in combination with Rd or Pd, dostarlimab (anti-PD-1 antibody), or isatuximab in patients with relapsed/refractory multiple myeloma

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DREAMM-9: belantamab mafodotin in combination with bortezomib, lenalidomide, and dexamethasone in patients with newly diagnosed multiple myeloma who are ineligible for ASCT

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DREAMM-11: a dose-escalation study of belantamab mafodotin in Japanese patients with relapsed/refractory multiple myeloma

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DREAMM-12: a pharmacokinetics and safety study of belantamab mafodotin in patients with relapsed/refractory multiple myeloma who have normal or varying degrees of impaired renal function

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DREAMM-13: a pharmacokinetics and safety study of belantamab mafodotin in patients with relapsed/refractory multiple myeloma who have normal or varying degrees of impaired hepatic function

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GSK2857914 | Unconjugated anti-BCMA antibody

DREAMM-20: study to investigate the safety and efficacy of GSK2875914 as monotherapy and in combination with other treatments in patients with multiple myeloma

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MULTIPLE MYELOMA Phase 2

Belantamab mafodotin | Anti-BCMA antibody‑drug conjugate*

DREAMM-6: study to investigate alternative dosing regimens of belanatamab mafodotin in patients with relapsed/refractory multiple myeloma

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DREAMM-14: study to investigate alternative dosing regimens of belantamab mafodotin in patients with relapsed/refractory multiple myeloma

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DREAMM-5: platform study of belantamab mafodotin alone and in combination with GSK3174998 (OX40 agonist antibody), feladilimab (ICOS agonist IgG4 antibody), nirogacestat alone or in combination with Rd or Pd, dostarlimab (anti-PD-1 antibody), or isatuximab in patients with relapsed/refractory multiple myeloma

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GSK2857914 | Unconjugated anti-BCMA antibody

DREAMM-20: study to investigate the safety and efficacy of GSK2875914 as monotherapy and in combination with other treatments in patients with multiple myeloma

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MULTIPLE MYELOMA Phase 3

Belantamab mafodotin | Anti-BCMA antibody‑drug conjugate*

DREAMM-7: belantamab mafodotin in combination with bortezomib and dexamethasone compared with daratumumab, bortezomib, and dexamethasone in patients with relapsed/refractory multiple myeloma

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DREAMM-8: belantamab mafodotin in combination with pomalidomide and dexamethasone vs pomalidomide, bortezomib, and dexamethasone in relapsed/refractory multiple myeloma

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NCT04549363: Characterization of corneal epithelial changes in patients with relapsed/refractory multiple myeloma treated with belantamab mafodotin

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MYELOFIBROSIS Phase 2

Momelotinib | JAK1/2 and ACVR1 inhibitor

NCT0344113: extended access of momelotinib in patients with primary myelofibrosis or post-polycythemia vera/post-essentail thrombocythemia myelofibrosis

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ODYSSEY: an open-label study to evaluate momelotinib in combination with luspatercept in participants with transfusion-dependent primary or secondary myelofibrosis

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OTHER SOLID TUMORS Phase 1

Dostarlimab | Anti–PD-1 antibody

GARNET~: dose-escalation and ‑expansion study in patients with advanced solid tumors

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Cobolimab | Anti–TIM-3 antibody

AMBER§: dose-escalation and -expansion study of cobolimab alone or in combination with other anticancer agents in patients with advanced solid tumors

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Nelistotug | Anti-CD96 antibody

NCT04446351: first-time-in-human study of Nelistotug as monotherapy and in combination with dostarlimab with or without belrestotug in advanced solid tumors

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Niraparib | PARP inhibitor

NCT03329001: a crossover bioavailability and bioequivalence study of niraparib tablet and capsule formulation in patients with advanced solid tumors

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Belrestotug | Anti-TIGIT IgG1 antibody¶

TIG-006¶: study of belrestotug in combination with standard of care or investigational therapy in advanced solid tumors

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GSK4381562 | Anti-PVRIG antibody

NCT05277051: first-time-in-human, open label study of GSK4381562 administered as monotherapy, in combination with dostarlimab, or in combination with dostarlimab and belrestotug in patients with selected advanced solid tumors

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GSK4524101

NCT06077877: study to determine maximum tolerated dose of GSK4524101 as monotherapy and in combination with niraparib in patients with solid tumors

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GSK5733584

NCT06431594: a clinical study to evaluate the safety, tolerability, pharmacokinetics, and clinical activity of GSK5733584 for injection in subjects with advanced solid tumors

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GSK5764227

NCT06551142: a clinical study to evaluate the safety, tolerability, pharmacokinetics, and clinical activity of GSK5764227 in participants with advanced solid tumors

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OTHER SOLID TUMORS Phase 2

Niraparib | PARP inhibitor

Long-term treatment-extension study in patients who have completed a prior GSK-sponsored niraparib study

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PAVO£: niraparib as monotherapy in the treatment of patients with locally advanced or metastatic solid tumors with a PALB2 mutation

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NCT04641247: a long-term treatment-extension study of niraparib in patients who have completed a prior GSK-sponsored niraparib study

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Belrestotug | Anti-TIGIT IgG1 antibody¶

TIG-006¶: study of belrestotug in combination with standard of care or investigational therapy in advanced solid tumors

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GSK4524101

NCT06077877: study to determine maximum tolerated dose of GSK4524101 as monotherapy and in combination with niraparib in patients with solid tumors

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OVARIAN CANCER Phase 1

Dostarlimab | Anti-PD-1 antibody

OPAL: study of treatment with niraparib in combination with dostarlimab and bevacizumab in patients with ovarian cancer

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OVARIAN CANCER Phase 2

Niraparib | PARP inhibitor

OVARIO: study of first-line maintenance therapy with niraparib and bevacizumab following response on front-line platinum-based chemotherapy and bevacizumab in patients with advanced ovarian cancer

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OPAL: study of treatment with niraparib in combination with dostarlimab and bevacizumab in patients with ovarian cancer

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OVARIAN CANCER Phase 3

Dostarlimab | Anti-PD-1 antibody dostarlimab | Anti-PD-1 antibody

FIRST†: study of niraparib alone or in combination with dostarlimab and/or bevacizumab as maintenance therapy following first-line treatment with platinum-based chemotherapy alone or in combination with dostarlimab and/or bevacizumab in newly diagnosed advanced ovarian cancer

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Niraparib | PARP inhibitor dostarlimab | Anti-PD-1 antibody

FIRST†: study of niraparib alone or in combination with dostarlimab and/or bevacizumab as maintenance therapy following first-line treatment with platinum-based chemotherapy alone or in combination with dostarlimab and/or bevacizumab in newly diagnosed advanced ovarian cancer

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Disclaimer

This document contains information for healthcare providers and is intended solely for educational purposes. This display includes ongoing clinical trials for both approved and investigational compounds.

Some agents are approved in select indications. Inclusion in this display does not imply regulatory approval for these compounds or all indications. Information about all trials can be found at www.clinicaltrials.gov.

Footnotes

† In collaboration with ENGOT, the European Network of Gynaecological Oncological Trial groups.

‡Not yet enrolling.

¶Collaboration and license alliance between GSK and iTeos Therapeutics.

~This trial is no longer enrolling patients with endometrial cancer.

§This trial is only enrolling patients for Cohort 2E in NSCLC.

£ Collaboration between GSK and Tempus.

¥ Collaboration and license alliance between GSK and iTeos Therapeutics.