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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 Bintrafusp, these include (updated June 2020):]
Types of Research Priority will be given to investigator sponsored study proposals that aim to explore:

• Safety and efficacy of bintrafusp alfa in tumor types providing a strong TGF-β rationale • Safety and efficacy of combinations with bintrafusp alfa based on strong scientific rationale • Use of bintrafusp alfa in early stage disease with existing evidence of TGF-β signalling/mechanism of action • Further investigation of the mechanism of action of bintrafusp alfa and the clinical application • Definition/identification of responders or non-responders (e.g. biomarker analysis) • Understanding of primary and acquired resistance to bintrafusp alfa

Areas of Interest Preference will also be given to translational studies involving the following tumor types:

• Gastrointestinal (prioritizing biliary tract cancer) • Lung (prioritizing NSCLC) • Gynecological (prioritizing cervical cancers) • Genitourinary (prioritizing urothelial cancer)

While the above tumor types are priority areas of interest, proposals in other tumor types may be considered


[For niraparib, these include, but are not limited to (updated April 2020):]
Ovarian Cancer:
• Sequencing of Niraparib (PARPi vs bevacizumab, PARPi after PARPi, mechanisms and overcoming PARPi resistance)
• Combinations with the pipeline and non-pipeline molecules (Homologous Recombinant proficient (HRp), platinum-resistant Ovarian Cancer, PARPi resistance, maintenance setting, chemo-free combinations)
• Neoadjuvant therapy

Lung Cancer
• Brain metastases
• Combinations with approved and/or investigational agents
• Role of BRCAm and DNA repair mutations in Non-Small Cell Lung Cancer

Breast Cancer
• Brain metastases
• Early (non-metastatic) disease
Endometrial Cancer
• High-risk, locally advanced not eligible for chemoradiation

Niraparib Combinations:
• Niraparib combinations with approved or investigational agents with strong scientific rationale, including but not limited to Ovarian, Breast, Lung, Endometrial, and Colorectal Cancers
• Novel mechanisms of action with an expected synergistic effect, with a focus on Homologous Recombinant proficient (HRp)/non-BRCAm populations

Novel Ideas:
• Brain metastases in any tumor
• Activation of alternate pathways (e.g. STING)
• Targeted approach with biomarkers outside of Homologous Recombination Deficiency (HRD)/Homologous Recombination Repair (HRR)
• Using ctDNA as an indicator for early relapse
• Other tumors not listed above, including but not limited to Pancreatic, Cervical and Gastric, including basket studies
• We are also interested in other studies for which a strong scientific rational exists


[For Dostarlimab these include (updated May 2020):]
Endometrial Cancer
• Adjuvant/neoadjuvant in early stage/locally advanced EC (inclusive of MMRd/MSI-H 1L)
• Chemotherapy free alternative
• Combinations with RT
• Combinations with RT in early stage/locally advanced setting
• Combination with bevacizumab +/- HRT
• Real-world evidence, epidemiology and treatment landscape for EC to determine SOC, outcomes and resource utilization

Combination Therapies
Dostarlimab +
• ICOS
• TIM3
• PARPi
• RT
• VEGF
• Hormonal Therapy
Combinations to overcome resistance

Potential New Indications and Novel Ideas
Breast
• Early Stage Breast Cancer (HR+/-, HER2+/-)
• Suboptimal response to SOC Therapy
• Metastatic breast cancer combinations
• Combination with other therapies
Bladder and Prostate
GI Tumors
• MSI-H/dMMR Colorectal
• MMRp in combination with other agents
Pancreatic 1L Therapy
HPV associated Mucosal Squamous Cancers
GYN (cervical/uterine/ovarian) in combination with other agents
Targeted biomarker patient populations
Translational/MoA
Areas of unmet medical need

Dostarlimab Differentiation
Economic modelling (cost-effectiveness and cost utilization in EC


[For belantamab mafodotin (GSK 2857916), these include, but are not limited to (updated April 2020):]
•Clinical Multiple Myeloma: combinations, sequencing, and differentiation in relapsed/refractory multiple myeloma (RRMM) and newly diagnosed multiple myeloma (NDMM)
•Other Tumors of Interest: BC lymphomas, plasma cell leukemia, POEMS
•Safety/Tolerability and Translational Studies: across all indications


[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 (GSK3326595 team), these include proposals that meet one or more of the following areas of interest (Updated January 2020):]
• 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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