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The Supported Studies Programme

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Oncology



Timelines





[Below are the Areas of Interest for consideration for GSK’s Assets, Patient Empowerment Alliance, and Experimental Medical Unit for Translational Research:]

[For anti-TIGIT GSK4428859A(GSK’859A)/EOS-448, these include (updated January 2023):]


Head and neck cancer
•Window of opportunity studies with GSK’859A/EOS-448 based combinations
•Studies evaluating sequencing of GSK’859A/EOS-448 based combinations and chemotherapy/radiation

Gastric cancer
•Window of opportunity studies with GSK’859A/EOS-448 based combinations
•Signal seeking trials with GSK’859A/EOS-448 based combinations that have a compelling design and strong scientific rationale; potentially synergistic combinations with GSK’859A/EOS-448 with strong, novel translational strategies and endpoints

Melanoma
•Window of opportunity studies with GSK’859A/EOS-448 based combinations
•Signal seeking trials with a compelling design and strong scientific rationale with unique translational endpoints that can be assessed in a pre/post-surgical setting

[For belantamab mafodotin (GSK 2857916), these include, but are not limited to (updated March 2023):]

Combination Therapies

Priority Combinations:
•Anti-CD38 agent +Kd combinations in RRMM
•Mezigdomide in combination with belamaf, in RRMM and in the maintenance setting
•T-cell engagers: non-BCMA, specific to GPRC5D and FCRH5 in combination with Pd or other SOC

Other Combinations:
•T-cells engagers: BCMA-targeted +/- SOC (alternating agent strategy)
•Agents w/scientific rationale – including preclinical

Sequencing:
•Use of belamaf in combination with SOC before or after treatment with other BCMA-targeting therapies (e.g., as maintenance or crossover for toxicity)
•Membrane-bound BCMA expression with BCMA-targeted therapies
- At baseline and time of progression with BCMA-targeted therapies
- At the time of initiation of new therapy for patients after coming off prior BCMA-targeted therapy (by dose if applicable)

Ocular Management:
•Real-world evidence:
-Ocular 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
-Physician assessments guiding alternative approaches to dosing decisions
•Supportive care for management of ocular AEs:
-Definition of clinically meaningful change in visual acuity (Snellen 20/50) and its differentiation from other ocular symptoms (eg, dryness, itching, pain)
-Mechanism for ocular toxicity
-Prophylactic and therapeutic solutions 
-Mitigation of ocular AEs, including dose modification, with focus on prevention/early intervention
-Assess the presentation and resolution of ocular AEs


[Momelotinib Areas of Interest (updated August 2023):]
Myelofibrosis(MF)
• Combination with novel agents (1L or as 'add-on') with potential for disease modification, not limited to:
- BET inhibitors (e.g. Pelabresib)
- TGF-beta targeting (e.g. Luspatercept)
- Telomerase inhibitors (e.g. Imetelstat)
- PIM1 inhibitors (e.g. TP-3654)
- MDM2 inhibitors (e.g. Navtemadlin, KRT-232)
- Interferon
• Pre-fibrotic MF
• Accelerated phase/blast phase MF
• Use of momelotinib in transplant setting
• Real-world experience of patients with MF treated with momelotinib


Disease areas outside myelofibrosis
• AML
• CMML
• JAK2+ MPN/MDS overlap syndrome
• Chronic GVHD
• ACVR-dependent tumor types, not limited to: diffuse intrinsic pontine glioma (DIPG); fibrodysplasia ossificans progressiva (FOP)
• Anemia of chronic illness with high hepcidin level
• Other hematologic indications with strong scientific rationale


[For Dostarlimab these include (updated October 2023):]
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
• Studies that can explore the neoadjuvant/perioperative dostarlimab hypothesis in other disease settings
• Studies that continue to explore the role of dostarlimab in other dMMR/MSI-H GI tumors and lung tumors
• Biomarker driven approaches for dostarlimab, including potentially synergistic GSK combination therapies

[For niraparib, these include, but are not limited to (updated January 2024):]

Ovarian Cancer
•Sequencing of therapies following PARPi as maintenance treatment
• Exploring combinations aimed at overcoming PARPi resistance
• Investigation of innovative strategies for identifying the appropriate patient population that could benefit from PARPi therapy
• Exploring combinations strategies in patients considered no longer eligible for platinum-based therapy
• Exploring combination strategies to optimize treatments options for HRp populations
• Optimizing patient experience and mitigation of adverse effects
• Novel proof of concept proposals to expand knowledge on the role of PARPi in ovarian cancer

Lung Cancer (NSCLC)
• Studies that target specific populations
• Studies addressing NSCLC maintenance challenges
• Studies with biomarker-enriched patient population
• Studies addressing the optimal sequence of treatment in NSCLC

Breast Cancer
• 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
• Studies with biomarker-enriched patient population
• Novel approaches to address brain metastases secondary to solid tumors
• Combination treatment which partners niraparib with an approved therapy in glioma or glioblastoma

Other Solid Tumors
• Any other signal seeking trial in tumor types with a compelling design and strong scientific rationale (considered on a case-by-case basis: only if Niraparib is not the lead asset)

[Patient Empowerment Alliance (updated March 2023):]

The Patient Empowerment Alliance (P.E.A.) elevates the patient voice to empower patients as core members of their care team. Through the GSK Supported Studies program, the P.E.A. supports evidence-based research that has a measurable impact on patient care outcomes, enabling approaches that target the patient experience in oncology.

Patient Experience and Engagement
•Leverage novel techniques, tools and clinical approaches to empower patients as core members of their care team via patient engagement, provider engagement and shared decision making at key inflection points of the patient journey (i.e., prevention, diagnosis, treatment and care, end of life care and survivorship). Proposals with a focus on at-risk and underserved populations will be given priority.

Care Coordination
•Leverage novel, patient-centered techniques, tools, support, education (i.e., measuring quality of patient interactions with their care team, impact of information shared) and clinical approaches. The goal is to support patients and caregivers, helping them navigate the complexity of care coordination at disease diagnosis and treatment. Proposals with a focus on at-risk and underserved populations will be given priority.


Patient Literacy
•Develop content, tools, channels and interventions to expand patient literacy and disease understanding, providing trusted and validated information (i.e., interpreting disease and treatment information received, community-based engagement), from disease prevention to diagnosis, through to survivorship or end-of-life care, supporting patients to empower them in making good treatment and care decisions. Proposals with a focus on at-risk and underserved populations will be given priority.

Disease areas of focus for GSK’s Patient Empowerment Alliance are:
•Multiple myeloma
•1L+ ovarian cancer
•Lung cancer (added for 2022)
•Endometrial cancer (added for 2022)
•Myelofibrosis

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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