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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.
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.
View our ongoing, innovative research with oncology diseases.
DISEASE STATES
IOLite: dose-finding study of dostarlimab in combination with niraparib, cobolimab, bevacizumab, and/or platinum-based doublet chemotherapy in advanced or metastatic cancer
IOLite: dose-finding study of dostarlimab in combination with niraparib, cobolimab, bevacizumab, and/or platinum-based doublet chemotherapy in advanced or metastatic cancer
IOLite: dose-finding study of dostarlimab in combination with niraparib, cobolimab, bevacizumab, and/or platinum-based doublet chemotherapy in advanced or metastatic cancer
OPAL: combination treatment with niraparib, dostarlimab, and bevacizumab in ovarian cancer
OPAL: combination treatment with niraparib, dostarlimab, and bevacizumab in ovarian cancer
Long-term follow-up from previous treatment with GSK adoptive cell therapies
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
IOLite: dose-finding study of dostarlimab in combination with niraparib, cobolimab, bevacizumab, and/or platinum-based doublet chemotherapy in advanced or metastatic cancer
AMBER: cobolimab monotherapy and in combination with dostarlimab, nivolumab, or GSK4074386 in advanced 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 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
SCOOP: dose escalation and cohort expansion of niraparib and dostarlimab in pediatric patients with recurrent or refractory solid tumors
TIG-006: basket study of GSK4428859A in combination with standard of care or investigational therapy in advanced solid tumors
TIG-006: basket study of GSK4428859A in combination with standard of care or investigational therapy in advanced solid tumors
Monotherapy and in combination with dostarlimab in recurrent or metastatic solid tumors
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.
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.
View our ongoing, innovative research with oncology diseases.
DISEASE STATES
Long-term treatment-extension study in patients who have completed a prior GSK-sponsored niraparib study
ENTRÉE-Lung: platform trial of novel regimens versus standard of care in NSCLC
PERLA: dostarlimab with chemotherapy vs pembrolizumab with chemotherapy in metastatic nonsquamous NSCLC
COSTAR: cobolimab in combination with dostarlimab and docetaxel in advance NSCLC
COSTAR: cobolimab in combination with dostarlimab and docetaxel in advance NSCLC
Monotherapy or in combination with pembrolizumab in advanced or recurrent NSCLC
DREAMM-6: Combination with Rd or Vd in RRMM
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
Extended access in patients with PMF or post-PV/post-ET MF
A pilot study in advanced myxoid/round cell liposarcoma
IGNYTE-ESO: master protocol--NY-ESO-1 and/or LAGE 1a-positive synovial sarcoma and myxoid/round cell liposarcoma
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
TIG-006: basket study of GSK4428859A in combination with standard of care or investigational therapy in advanced solid tumors
TIG-006: basket study of GSK4428859A in combination with standard of care or investigational therapy in advanced solid tumors
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.
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.
View our ongoing, innovative research with oncology diseases.
DISEASE STATES
ZEST: breast cancer maintenance in HER2-negative BRCA-mutated or triple-negative breast cancer with molecular disease based on presence of ctDNA after definitive therapy
RUBY: combination with carboplatin-paclitaxel in recurrent or primary advanced endometrial cancer
COSTAR: cobolimab in combination with dostarlimab and docetaxel in advance NSCLC
ZEAL-1L: niraparib with pembrolizumab vs placebo with pembrolizumab as maintenance therapy in NSCLC
COSTAR: cobolimab in combination with dostarlimab and docetaxel in advance NSCLC
DREAMM-3: monotherapy vs Pd in RRMM
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
