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
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
Dostarlimab | Anti–PD-1 antibody
AZUR-1: dostarlimab monotherapy in patients with untreated stage II/III dMMR/MSI-H locally advanced rectal cancer
Dostarlimab | Anti–PD-1 antibody
AZUR-2: dostarlimab perioperative monotherapy in patients with untreated T4N0 or stage III dMMR/MSI-H resectable colon cancer
Niraparib | PARP inhibitor
GLIOFOCUS: study comparing the clinical efficacy and safety of niraparib with temozolomide in adult participants with newly-diagnosed, MGMT unmethylated glioblastoma
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
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
Dostarlimab | Anti-PD-1 antibody
PERLA: dostarlimab with chemotherapy vs pembrolizumab with chemotherapy in metastatic nonsquamous NSCLC
Belrestotug | Anti-TIGIT IgG1 antibody¶
ENTRÉE-Lung: platform trial of novel regimens versus standard of care in NSCLC
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
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
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
Niraparib | PARP inhibitor
ZEAL-1L: niraparib with pembrolizumab vs placebo with pembrolizumab as maintenance therapy in NSCLC
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
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
DREAMM-9: belantamab mafodotin in combination with bortezomib, lenalidomide, and dexamethasone in patients with newly diagnosed multiple myeloma who are ineligible for ASCT
DREAMM-11: a dose-escalation study of belantamab mafodotin in Japanese patients with relapsed/refractory multiple myeloma
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
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
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
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
DREAMM-14: study to investigate alternative dosing regimens of belantamab mafodotin in patients with relapsed/refractory multiple myeloma
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
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
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
DREAMM-8: belantamab mafodotin in combination with pomalidomide and dexamethasone vs pomalidomide, bortezomib, and dexamethasone in relapsed/refractory multiple myeloma
NCT04549363: Characterization of corneal epithelial changes in patients with relapsed/refractory multiple myeloma treated with belantamab mafodotin
Momelotinib | JAK1/2 and ACVR1 inhibitor
NCT0344113: extended access of momelotinib in patients with primary myelofibrosis or post-polycythemia vera/post-essentail thrombocythemia myelofibrosis
Momelotinib | JAK1/2 and ACVR1 inhibitor
ODYSSEY: an open-label study to evaluate momelotinib in combination with luspatercept in participants with transfusion-dependent primary or secondary myelofibrosis
Dostarlimab | Anti-PD-1 antibody
GARNET~: dose-escalation and ‑expansion study in patients with advanced solid tumors
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
Niraparib | PARP Inhibitor
NCT03329001: a crossover bioavailability and bioequivalence study of niraparib tablet and capsule formulation in patients with advanced solid tumors
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
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
Belrestotug | Anti-TIGIT IgG1 antibody¶
TIG-006¶: study of belrestotug in combination with standard of care or investigational therapy in advanced solid tumors
GSK4524101
NCT06077877: study to determine maximum tolerated dose of GSK4524101 as monotherapy and in combination with niraparib in patients with solid tumors
GSK5733584
NCT06431594: a clinical study to evaluate the safety, tolerability, pharmacokinetics, and clinical activity of GSK5733584 for injection in subjects with advanced solid tumors
GSK5764227
NCT06551142: a clinical study to evaluate the safety, tolerability, pharmacokinetics, and clinical activity of GSK5764227 in participants with advanced solid tumors
Niraparib | PARP Inhibitor
Long-term treatment-extension study in patients who have completed a prior GSK-sponsored niraparib study
PAVO£: niraparib as monotherapy in the treatment of patients with locally advanced or metastatic solid tumors with a PALB2 mutation
NCT04641247: a long-term treatment-extension study of niraparib in patients who have completed a prior GSK-sponsored niraparib study
Belrestotug | Anti-TIGIT IgG1 antibody¶
TIG-006¶: study of belrestotug in combination with standard of care or investigational therapy in advanced solid tumors
GSK4524101
NCT06077877: study to determine maximum tolerated dose of GSK4524101 as monotherapy and in combination with niraparib in patients with solid tumors
Niraparib | PARP Inhibitor
OPAL: study of treatment with niraparib in combination with dostarlimab and bevacizumab in patients with ovarian cancer
Dostarlimab | Anti-PD-1 antibody
OPAL: study of treatment with niraparib in combination with dostarlimab and bevacizumab in patients with ovarian cancer
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
Long-term treatment-extension study in patients who have completed a prior GSK-sponsored niraparib study
OPAL: study of treatment with niraparib in combination with dostarlimab and bevacizumab in patients with ovarian cancer
Dostarlimab | Anti-PD-1 antibody
OPAL: study of treatment with niraparib in combination with dostarlimab and bevacizumab in patients with ovarian cancer
Niraparib | PARP Inhibitor
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
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.