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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 June 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
• Identification of biomarkers
• Studies addressing NSCLC maintenance challenges (pemetrexed comparison)
• Earlier stages NSCLC (e.g. II-IIIA)
• Niraparib in driver mutation resistant populations of NSCLC (EGFRm, ALKm, KRASm
• Chemo free combinations in NSCLC
• 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
• CNS studies considering brain protection
• Combinations with approved therapies
• Gliomas, particularly 1L or 2L GBM
• Evaluation of niraparib concentration and localization in CNS tumors
• Predictive markers of response to niraparib in CNS tumors
• Any other CNS tumors

Other Solid Tumors
• Signal seeking proposals in Head and Neck cancers, Bladder cancer, and Esophageal Cancers
• Combinations with approved and/or investigational agents or radiation therapy with a priority to ICI combinations
• 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

Patient Experience and Engagement
•Leverage novel techniques, tools (i.e. measuring care monitoring, impact of feedback channels), and clinical approaches to strengthen patient engagement, provider engagement and coordinating shared decision making.
•Support and educate patients in disease-area understanding (i.e. disease information, understanding of treatment options), adverse events, and care management strategies

Care Coordination
•Leverage novel, patient-centered techniques, tools (i.e. measuring quality of patient interactions with their care team, impact of information shared in these meetings) and clinical approaches which can optimize coordination across specialties and services
•Support and educate patients so they can understand the complexity and importance of care coordination and alignment in their disease treatment

Patient Literacy
•Develop validated content, tools, channels and interventions with a goal to expand patient literacy (i.e. interpreting disease and treatment information received), and support patients in making good treatment decisions


[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
• GI tumors with strong scientific rationale and unmet medical need including:
• Biomarker driven, potentially synergistic GSK combination therapies
• Incorporation of strong, novel translational strategies and endpoints


[For belantamab mafodotin (GSK 2857916), these include, but are not limited to (updated Aug 2021):]

Combination Therapies

Priority Combinations:
•Anti CD38 based combos +/- K(d), Rd
•CELMoDs
•T cells engagers: Non-BCMA, Specific to GPRC5D and FCRH5


Other Novel Combinations:
•T cells engagers: BCMA-targeted
•PARPi: Preclinical
•Agents w/ scientific rationale
•Cyclophosphamide based combinations: CyBorD

Sequencing
•Use before/after treatment with other BCMA-targeting therapies (Bela before CAR-T, bi-specifics before/after Bela)
•Re-sensitization of patients to therapies that they were previously refractory to (i,e Dara-Len/Bortezomib)
•BCMA expression post-BCMA targeted therapies

- At the time of progression with Bela
- At the time of initiation of new therapy for patients after coming off prior BCMA target therapy (by dose if applicable)
•Re-challenge in different combinations (Bela Rd→Bela Kd)

Cornea Management
•Real-world evidence:
- Corneal management in Real World setting and impact on efficacy/AEs/patients and physicians’ choice

•Safety Monitoring:
- Use of Visual Acuity or symptoms as a surrogate: Visual Acuity and symptoms according to OSDI data
- PRO potential surrogate for keratopathy: Patient Reported outcome approach for making treatment decisions (i.e. dosing, dose holds)
•Supportive care for management of ocular AEs:
- Mechanism for ocular toxicity
- Therapeutic solutions
- Physiology having impact of treatment
•Mitigation of corneal AEs, including dose modification, with focus on prevention/early intervention
•Revised VA scoring

Patient Experience and Engagement
•Leverage novel techniques, tools (i.e. measuring care monitoring, impact of feedback channels), and clinical approaches to strengthen patient engagement, provider engagement and coordinating shared decision making.
•Support and educate patients in disease-area understanding (i.e. disease information, understanding of treatment options), adverse events, and care management strategies

Care Coordination
•Leverage novel, patient-centered techniques, tools (i.e. measuring quality of patient interactions with their care team, impact of information shared in these meetings) and clinical approaches which can optimize coordination across specialties and services
•Support and educate patients so they can understand the complexity and importance of care coordination and alignment in their disease treatment

Patient Literacy
•Develop validated content, tools, channels and interventions with a goal to expand patient literacy (i.e. interpreting disease and treatment information received), and support patients in making good treatment decisions

[For NY-ESO-1 TCR T cell therapy, these include, but are not limited to (Updated March 2021):]
Non-interventional studies:
• Biology of NY-ESO-1 and HLA expression
• Differentiation of safety and efficacy between cancer/testis antigen targets
• Pre-clinical studies of 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
• Assessment of HLA-A*02 and NY-ESO-1/LAGE-1a frequencies in solid tumours.
• Methods to simplify the supply and delivery of autologous cell therapy

[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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