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Oncology
Timelines
[Below are the Areas of Interest for consideration for GSK’s Assets:]
[For belantamab mafodotin these include (updated November 2024):]
Combination Therapies:
• Belamaf in combination with mezigdomide (plus other CeLMoDs) in the RRMM & FL maintenance setting.
• Belamaf in combination with non-BCMA–targeting T-cell engagers, particularly those specific to GPRC5D (plus Pd or other SoC), FcRH5.
• Induction with BCMA-targeting T-cell engagers followed by low-dose belamaf maintenance therapy.
• Agents with scientific rationale including combinations that address areas of high unmet need (high risk, early relapse, etc.)
Patient Populations:
• Clinical use and outcomes following belamaf treatment in minority populations, including those of African American descent.
• Belamaf efficacy and safety in subpopulations of interest not addressed through existing studies.
Additional Therapeutic Targets:
• BCMA expressing malignancies (amyloidosis, waldenstrom, etc.).
• Non-malignant conditions where plasma cells play a key component to disease (e.g. Lupus etc.)
Sequencing:
• Use of belamaf (plus SoC) before treatment with other BCMA-targeting therapies (e.g., crossover for toxicity).
• Membrane-bound BCMA expression with BCMA-targeted therapies (translational elements for incorporation into interventional studies)
- 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)
Mechanism of Action:
• Deeper understanding of Immune Cell Death (ICD).
Ocular Management Safety monitoring:
• Use of visual acuity or symptoms as a surrogate; safety assessment according to symptom-based dose modification approach.
• 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 (e.g., dryness, itching, and pain).
• Mechanisms underpinning belamaf-associated ocular events.
[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.
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.