[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 Jan 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 Oct 2022):]


Combination Therapies

Priority Combinations:
•Anti-CD38 based combinations +K(d) in RRMM
•CELMoDs (iberdomide, mezigdomide) in combination, 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
•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-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
-Physician 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

[For momelotinib, these include, but are not limited to (updated July 2022):]

Myelofibrosis
• Combinations with other agents seeking to modify disease progression and/or improve the symptoms of MF

Other areas of interest
• Monotherapy or combination in FLT3 Acute Myeloid Leukemia
• ACVR-dependent tumor types, including, but not limited to:
- Diffuse Intrinsic Pontine Glioma
- Fibrodysplasia Ossificans Progressiva
• Anemia of chronic illness associated with high hepcidin levels
• Chronic GVHD
• Other indications with strong scientific rationale

[For Dostarlimab these include (updated October 2022):]
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
• dMMR/ MSI-H GI tumors 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 niraparib, these include, but are not limited to (updated April 2022):]

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
•Studies with biomarker enriched patient population
•Studies addressing NSCLC maintenance challenges (pemetrexed comparison)
•Studies that target specific populations (e.g., elderly patients)
•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
•Studies considering assessment of Patient Reported Outcomes
•Studies in Lung and Breast tumors with Brain metastases that are assessing a delay
or a reduction of local therapy (e.g. surgery or radiotherapy)
•Any novel approach to address brain metastases secondary to solid tumors
•Combination treatment which partners niraparib with an approved therapy in Glioma (especially Glioblastoma)

Other Solid Tumors
•Proposals in Mesothelioma
•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 Empowerment Alliance (updated March 2022):]

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.

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)

[Experimental Medical Unit (EMU) for Translational Research (updated June 2022):]

Indications: Tier 1 (NSCLC, BrCA, HNSCC, CRC); Tier 2 (CRPC, Gastric, OvCa)
– Clinical utility of ctDNA in solid tumors
• ctDNA as MRD in adjuvant setting
• ctDNA as molecular response biomarker-lead time compared to clinical imaging
• ctDNA as prognostic biomarker (tumor burden) in metastatic disease
– Access to biomarker datasets and/or samples associated with clinical outcome
• Spatial transcriptomics, scRNAseq
• In PD1 resistant setting
• Other SOC resistant setting
– IO PD biomarkers
• Functional assays
• Immuno-peptidomics
• Understand how peripheral PD biomarker relates to tumor PD
– Novel biomarker approaches
• Novel liquid biopsy approaches
• Novel imaging
– Novel translational in vitro and in vivo models
• Organoid/tumor explant models with preserved immune infiltrates (NK, B cells, TAMs, etc) with associated clinical response data.
• In vitro and in vivo models of resistance to DDR pathway inhibitors, anti-PD1 and SOC
• Novel models for human IO dose level and schedule prediction
– Mechanistic understanding of inhibitory and stimulatory checkpoints within the CD226 axis
– DDR pathway inhibitors
• Mechanisms of acquired resistance to PARP inhibitors
• Biomarkers of HRD beyond ovarian and breast cancers; pan-tumor HRD biomarker; lung cancer HRD biomarkers
• Identification of novel combination partners to overcome innate and acquired resistance