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The Supported Studies Programme

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 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 October 2024):]
Myelofibrosis (MF) Combinations
Combination of MMB with agents (1L or as 'add-on') with potential for disease modification, not limited to:
•   Anti-HJV (e.g., DISC-0974)
•   BET inhibitors (e.g., Pelabresib)
•   JAK2/ACVR1 inhibitors (e.g., INCB00928)
•   MDM2 inhibitors (e.g., Navtemadlin)
•   PIM1 inhibitors (e.g., TP-3654)
•   Telomerase inhibitors (e.g., Imetelstat)
•   TGFß modulators (e.g., KER-050)
•   XPO1 inhibitors (e.g., Selinexor)

Note: Proposals to address other hematologic malignancies may be considered for those with extraordinary scientific rationale (case-by-case)


[For Dostarlimab these include (updated November 2024; pending further updates soon):]
Investigation of dostarlimab in Gyn-Onc, Head and Neck, and Colorectal/GI indications that can support current registrational studies through meaningful evidence generation.

[For niraparib, these include (updated November 2024):]
Ovarian Cancer
• Investigation of PARPi monotherapy strategies for identifying the appropriate patient population that could benefit from PARPi monotherapy.
• Optimizing patient experience and mitigation of adverse effects.

Glioblastoma
• Studies exploring treatment strategies in methylated patient population.

[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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