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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.
View our ongoing, innovative research with oncology diseases.
Phase 1 Overview
This is the first time a new vaccine or medicine is tested in humans; it will usually be given to a small group of healthy volunteers, or it may be tested on patients who have the condition it is designed to treat. The principal objectives in phase I are to ensure the new vaccine or medicine presents no major safety issues, and to see clear evidence that it can reach the targeted body area and remain there long enough to deliver its potential benefits. We also seek to gain preliminary evidence the vaccine or medicine can offer therapeutic value or help to prevent the disease in question.
DISEASE STATES
No studies exist in this phase
DREAMM-5: platform study of monotherapy and in combination with GSK3174998, feladilimab, nirogacestat, dostarlimab, or isatuximab in RRMM
DREAMM-9: combination with VRd in NDMM ineligible for ASCT
DREAMM-11: dose escalation in Japanese patients with RRMM
DREAMM-12: monotherapy in patients with RRMM who have normal or impaired renal function
DREAMM-13: monotherapy in patients with RRMM who have normal or impaired hepatic function
DREAMM-20: alone or in combination with standard of care or novel agents and Rd in multiple myeloma
OPAL: combination treatment with niraparib, dostarlimab, and bevacizumab in ovarian cancer
OPAL: combination treatment with niraparib, dostarlimab, and bevacizumab in ovarian cancer
GSK3745417 alone in patients with relapsed or refractory myeloid malignancies, including AML and HR‑MDS
First-time-in-human study of GSK3745417 alone or in combination with dostarlimab in advanced solid tumors
GARNET~: dose-escalation and ‑expansion study in advanced solid tumors
SCOOP: dose escalation and cohort expansion of niraparib and dostarlimab in pediatric patients with recurrent or refractory solid tumors
CITRINO: GSK4074386 monotherapy, in combination with dostarlimab, or in combination with dostarlimab and bevacizumab with either mFOLFOX6 or FOLFIRI in advanced solid tumors
GSK6097608 monotherapy and in combination with dostarlimab with or without belrestotug in advanced solid tumors
Bioavailability and bioequivalence of niraparib tablet and capsule in advanced solid tumors
SCOOP: dose escalation and cohort expansion of niraparib and dostarlimab in pediatric patients with recurrent or refractory solid tumors
GSK4381562 as monotherapy, in combination with dostarlimab, or in combination with dostarlimab and belrestotug in recurrent or metastatic solid tumors
AMBER§: cobolimab monotherapy and in combination with other anticancer agents in advanced solid tumors
Belrestotug | Anti-TIGIT IgG1 antibody¥
TIG-006¥: basket study of belrestotug in combination with standard of care or investigational therapy in advanced solid tumors
Phase 2 Overview
At this stage, the potential vaccine or medicine is usually tested to understand the effectiveness against the disease it is designed to treat and appropriate dosing levels. The performance of the medicine in one group of patients may be compared against another group of patients receiving a placebo (a treatment that looks the same as the potential new medicine but has no active ingredients) or an existing treatment.
DISEASE STATES
Long-term treatment-extension study in patients who have completed a prior GSK-sponsored niraparib study
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
Master protocol—platform study of novel immunotherapy combinations in previously untreated, locally advanced unresectable/metastatic, PD-L1–selected NSCLC
DREAMM-6: combination with Rd or Vd in RRMM
DREAMM-14: alternative dosing regimens in RRMM
DREAMM-5: platform study of monotherapy and in combination with GSK3174998, feladilimab, nirogacestat, dostarlimab, or isatuximab in RRMM
DREAMM-20: alone or in combination with standard of care or novel agents and Rd in multiple myeloma
OVARIO: combination with bevacizumab as 1L maintenance therapy in advanced ovarian cancer
Long-term treatment-extension study in patients who have completed a prior GSK-sponsored niraparib study
OPAL: combination treatment with niraparib, dostarlimab, and bevacizumab in ovarian cancer
OPAL: combination treatment with niraparib, dostarlimab, and bevacizumab in ovarian cancer
No studies exist in this phase
Long-term treatment-extension study in patients who have completed a prior GSK-sponsored niraparib study
PAVO£: monotherapy in patients with locally advanced or metastatic solid tumors with a PALB2 mutation
Belrestotug | Anti-TIGIT IgG1 antibody¥
TIG-006¥: basket study of belrestotug in combination with standard of care or investigational therapy in advanced solid tumors
Extended access in patients with PMF or post‑PV/post-ET MF
AZUR-1: dostarlimab monotherapy in dMMR/MSI-H locally advanced rectal cancer
Phase 3 Overview
This phase consists of a much larger and potentially longer trial, often involving hundreds or possibly thousands of participants from a range of different countries. The principal objectives in phase III are to demonstrate the safety and effectiveness of the new vaccine or medicine in the typical patient likely to use it; confirm effective dosing levels; identify contraindications; build knowledge of the benefits of the vaccine or medicine and compare them with any risks; and compare results against any currently achieved by existing treatments. Regulators will determine how a new product should be used and which patients should qualify for it based on all the evidence from clinical and pre-clinical studies.
DISEASE STATES
No studies exist in this phase
RUBY: combination with carboplatin-paclitaxel in primary advanced or first recurrent endometrial cancer
COSTAR Lung: cobolimab in combination with dostarlimab and docetaxel in advanced NSCLC
ZEAL-1L: niraparib with pembrolizumab vs placebo with pembrolizumab as maintenance therapy in NSCLC
COSTAR Lung: cobolimab in combination with dostarlimab and docetaxel in advanced NSCLC
Belantamab mafodotin | Anti-BCMA antibody‑drug conjugate*
DREAMM-7: combination with Vd vs DVd in RRMM
DREAMM-8: combination with Pd vs PVd in RRMM
Characterization of corneal epithelial change in RRMM
FIRST†: niraparib alone or in combination with dostarlimab and/or bevacizumab as maintenance therapy in advanced ovarian cancer
FIRST†: niraparib alone or in combination with dostarlimab and/or bevacizumab as maintenance therapy in advanced ovarian cancer
AZUR-2‡: perioperative dostarlimab monotherapy in untreated T4N0 or stage III dMMR/MSI-H resectable colon cancer
Footnotes
*In-license or other partnership with third party.
† In collaboration with ENGOT, the European Network of Gynaecological Oncological Trial groups.
‡Not yet enrolling as of April 10, 2023.
¶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.
