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The Supported Studies Programme
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Oncology



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The below areas are of interest to the review committee. These were last updated in September 2019.

[For molibresib (GSK525762), these include, but are not limited to:]
GSK525762 in combination with:
• Niraparib in target populations
• Novel immunotherapy combinations with biomarkers
• Novel agents to identify optimal dosing

Metastatic breast cancer including, but not limited to:
• CDK4/6 failures
• Bone-only disease

• AML or solid tumors where RAS alterations are prevalent
• Studies that explore ability to induce HRD-like signatures and response to PARP inhibitors

[For belantamab mafodotin (GSK2857916), these include, but are not limited to:]
Relapsed Refractory Multiple Myeloma - GSK2857916 in combination with:
• Venetoclax
• Novel CD-38 agents
• Genomically guided therapies
• Thalidomide
• Cyclophosphamide
• Ixazomib
• Melphalan-sparing
• Others compounds invited for consideration
• IMiD┬«(immunomodulatory imide drug) + PI (proteasome inhibitors) not invited

High Risk Multiple Myleoma (Newly Diagnosed, Relapsed, Treatment-Ineligible or Treatment Eligible) – GSK2857916 in combination with:
• KRd (Carfilzomib, Lenalidomide, and Dexamethasone) +/- Monoclonal Antibodies
• Targeted Therapy: CD38, SLAMF7, PARPi’s, Venetoclax, t(11:14)
• For maintenance ┬▒ other agents

Treatment Eligible Multiple Myeloma - GSK2857916 in combination with:
• VRd (bortezomib, lenalidomide, dexamethasone)
• KRd (Carfilzomib, Lenalidomide, and Dexamethasone),
• KRDd (Carfilzomib, lenalidomide, dexamethasone, daratumumab),
• Venetoclax +/- Other (either pre/or post-Autologous Stem cell transplant (ASCT) or with transplant sparing intent)
• Consolidation after any induction with GSK’916 post-Complete Response (CR) to obtain Minimal residual disease(MRD) negativity
• For maintenance +/- other agents

High Risk Smoldering Multiple Myeloma
• Intermediate- and high-risk Smoldering Multiple Myeloma

[For PRMT5 inhibitor (GSK3326595 team), these include proposals that meet one or more of the following areas of interest:]
• Clinical studies that explore indications, identified by biology-driven concepts, that have a high level of clinical success and/or shed light on the mechanism of anti-tumor response of PRMT5 inhibition. These studies could include such indications as:
• Tumors that contain no mutations in TP53 (i.e., p53 wild-type tumors)
• Tumors harboring attenuated mRNA splicing (e.g., splice-mutant solid tumor or hematologic malignancies)
• Translocation-associated tumors (e.g., Notch, BCL-6, or transcription factors)
• Viral associated tumors (e.g., EBV- or KSHV-driven tumors)
• Cancers expressing high levels of c-Myb
• Other general novel biomarker-driven proposals may be evaluated on a case-by-case basis with adequate justification
• Clinical studies that explore indications that are identified based on clinical and/or pre-clinical considerations. These studies could include:
• Novel combinations of GSK3326595 with other agent(s). These proposals should provide evidence for presumption of benefit, based on the biology of the indicated tumor as well as the mechanism(s) of action (MOA) of the proposed combination
• Use of GSK3326595 in a maintenance setting after definitive therapy (e.g., surgery and/or radiation). These indications should focus on selected subsets of tumors that would be supported by MOA hypothesis.
• Translational or historical studies in adenoid cystic carcinoma, focusing on concepts that may drive further clinical support. Examples of such studies may include:
• Pre-clinical or translational studies to better understand the role of specific biomarkers and MOA in disease response and/or progression (e.g.Myb, p53)
• Studies to better understand the natural history of the disease or real-world evidence study proposals


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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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