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The Supported Studies Programme
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Oncology



Timelines





The below areas are of interest to the review committee


[For niraparib, these include, but are not limited to (updated February 2021):]
Ovarian Cancer
• Sequencing of therapies following PARPi as maintenance treatment
• Exploring combinations aimed at overcoming PARPi resistance
• Investigation of new diagnostics, including those using Artificial Intelligence (AI)
• Exploring combinations aimed at overcoming platinum resistance
• Exploring combination strategies in HRp populations
• Supportive care options
• Incorporation of strong, novel translational strategies and endpoints

Lung Cancer
• Combinations with approved and/or investigational agents or radiation therapy with a priority to ICI combinations
• Identification of biomarkers for synthetic lethality in NSCLC
• Niraparib in earlier stages NSCLC (e.g. II-IIIA)
• ctDNA as prognostic indicator for niraparib in resectable NSCLC
• Niraparib in driver mutation resistant populations of NSCLC (EGFRm, ALKm, KRASm)
• Chemo free combinations in NSCLC
• Niraparib in MPM
• Niraparib to re-sensitize to anti-PD-(L)1 therapy
• Niraparib combinations in SCLC

Breast Cancer
• Early non-metastatic disease, including molecularly recurrent disease
• Exploring potentially synergistic combination therapy
• Investigation of novel biomarker testing strategies
• Incorporation of strong, novel translational strategies and endpoints

Innovation/Other Gynecologic Tumor Types
• Tumor types with strong scientific rationale including:
• Potentially synergistic combination therapy, including radiation
• Tumor types with or without impairment to DDR
• New diagnostic strategies, including those using Artificial Intelligence (AI)
• Incorporation of strong, novel translational strategies and endpoints

CNS Tumors
• Specific brain metastases studies
• Combinations with approved and/or investigational agents or radiation therapy
• Evaluation of niraparib concentration and localization in CNS tumors
• Any other CNS tumors

Other Solid Tumors
• Any other Signal seeking trial in tumor types with a compelling design and strong scientific rationale may be considered on a case-by-case basis
• Combinations with approved and/or investigational agents or radiation therapy with a priority to ICI combinations


[For Dostarlimab these include (updated February 2021):]
Endometrial Cancer
• Exploring combination therapy in MMRp/MSS populations
• Exploring potentially synergistic combination therapy
• Investigations of biomarker testing beyond MMR/MSI
• Incorporation of strong, novel translational strategies and endpoints

Breast Cancer
• Exploring potentially synergistic combination therapy with strong, novel translational strategies and endpoints.

Cervical Cancer
• Exploring potentially synergistic combination therapy with strong, novel translational strategies and endpoints

Other Cancers / Innovation
• Tumor types with strong scientific rationale and unmet medical need including:
•   Biomarker driven, potentially synergistic combination therapy (including radiation)
•   New diagnostic strategies, including those using Artificial Intelligence (AI)
•   Incorporation of strong, novel translational strategies and endpoints


[For belantamab mafodotin (GSK 2857916), these include, but are not limited to (updated December 2020):]

Belantamab Mafodotin in Combination with:
•Anti-CD38-based regimens
•CELMoDs
•Selinexor-based regimens
•Cyclophosphamide-based regimens

Special Populations
•Elderly (≥65 years)/frail
•Novel combinations in transplant eligible patients
•Post-allogeneic transplant
•Novel biomarker-driven populations
•Incorporation of MRD, NGS and NGF analyses

Sequencing
•Belantamab mafodotin treatment before or after other BCMA-targeted therapy
•Belantamab mafodotin re-challenge

Cornea
•Approaches to corneal AE mitigation
•Revised visual acuity scoring
•Real-world experience
•Pathophysiology

[For NY-ESO-1 TCR T cell therapy, these include, but are not limited to (Updated January 2020):]
Pre-clinical studies:
• Biology of NY-ESO-1 and HLA expression
• Differentiation of safety and efficacy between cancer/testis antigen targets
• Novel combinations of GSK3377794 with other agents (e.g. vaccines, T-cell growth factors, epigenetic-modifiers)
• New methods to identify NY-ESO-1/LAGE-1a positive tumors
• Methods to simplify the supply and delivery of autologous cell therapy

Your proposal should be discussed with your local MSL or the Global Medical Affairs Leader (ken.x.culver@gsk.com) before submission into the portal.


[For PRMT5 inhibitor (GSK 3326595 team), these include proposals that meet one or more of the following areas of interest (Updated March 2021):]
Increase MoA Understanding In:
•   Tumors that are sensitive to replication stress (e.g., those with a defective DNA damage response)
•   Tumors harboring dysregulated mRNA splicing (e.g., splicing factor mutant)
•   Tumors with low mutation burden
•   Tumors with MDM2 or MDM4 amplification
•   Tumors with BCL-6 translocations
•   Cancers with c-Myb amplifications, translocation or dysregulation
•   Potential novel biological context

Explore preclinical combinations and indications of interest:
•   Combinations with radiation, chemotherapy or other agents targeting DNA repair machinery that focus on exploiting vulnerabilities created by replication stress or defects in DNA damage repair.
•   Novel combinations in breast or ovarian cancer focused on SOC or targeted therapies with mechanistic rationale to support combination benefit (e.g., inhibitors of PI3K signaling, PARP, estrogen response pathway and the cell cycle)
•   Novel combinations in Myeloid malignancies, including combinations with SOC or based on current understanding of MoA around splicing dysregulation or other epigenetic therapies
•   Novel combinations in HPV+ tumors. These proposals may be focused on SOC or combinations based on current understanding of MoA

Although GSK are more likely to support studies aligned to our current areas of interest for supported studies, we are interested in supporting studies that are innovative and contribute to scientific knowledge relating to a product, a medical condition or advancing a technology.



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