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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 December 2021):]
Ovarian Cancer
• Sequencing of therapies following PARPi as maintenance treatment
• Exploring combinations aimed at overcoming PARPi resistance
• Investigation of new and innovative diagnostic strategies
• Exploring combinations aimed at overcoming platinum resistance
• Exploring combination strategies in HRp populations
• Supportive care options
• Novel proof of concept proposals to expand knowledge on the role of PARPi in ovarian cancer

Lung Cancer
• Identification of biomarkers
• Studies addressing NSCLC maintenance challenges (pemetrexed comparison)
• Chemo free combinations in NSCLC

Breast Cancer
• Early non-metastatic disease, including molecularly recurrent disease
• Exploring potentially synergistic combination therapy
• Investigation of novel biomarker testing strategies
• Novel proof of concept proposals to expand knowledge on the role of PARPi in breast cancer

Innovation/Other Gynecologic Tumor Types
• Tumor types with strong scientific rationale including:
• Potentially synergistic combination therapy, including radiation
• Biomarker driven studies
• Investigation of new and innovative diagnostic strategies
• Novel proof of concept proposals to expand knowledge on the role of PARPi in gynecologic tumors

CNS Tumors
• Combinations with approved therapies
• Predictive markers of response to niraparib in CNS tumors
• Any other CNS tumors

Other Solid Tumors
• Proposals in Head and Neck cancers
• 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 December 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 and Lung 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 Nov 2021):]

Combination Therapies

Priority Combinations:
•Anti-CD38 based combinations +K(d) in RRMM
•CELMoDs, Iberdomide in combination with CELMoDs in RRMM
in the maintenance setting
•T-cells engagers: Non-BCMA, Specific to GPRC5D and FCRH5 +/- SOC

Other Combinations:
•T-cells engagers: BCMA-targeted +/- SOC (alternating agent strategy)
•Agents w/scientific rationale – including preclinical
•Cyclophosphamide based combinations: with CyBorD as priority

Sequencing:
•Use before/after treatment with other BCMA-targeting therapies (Belamaf before CAR-T, bi-specifics before/after Belamaf)
•BCMA expression post-BCMA targeted therapies
-At the time of progression with BCMA targeted therapies
-At the time of initiation of new therapy for patients after coming off prior BCMA target therapy (by dose if applicable)

•Re-sensitization of patients to therapies that they were previously refractory to (e.g. Dara/Len/Bortezomib)

•Re-treatment or 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 (e.g. dosing, dose holds)
-Ophthalmic assessments guiding alternative approaches to dosing decisions
•Supportive care for management of ocular AEs:
-Mechanism for ocular toxicity
-Therapeutic solutions

•Mitigation of corneal AEs, including dose modification, with focus on prevention/early intervention
•Assess the presentation and resolution of cornea AEs

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

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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