Strategies for Late-Phase Development to Address the Challenges of PD-1/PD-L1 Therapy: A Pathway Toward 2030
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By
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Elena A. Andresyuk
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Natalya O. Porozova
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Georgii D. Londaridze
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Ivan S. Moiseev
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Polina V. Kotselyabina
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Yuri B. Porozov
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July 20, 2026
Clinical Scorecard: Strategies for Late-Phase Development to Address the Challenges of PD-1/PD-L1 Therapy: A Pathway Toward 2030
At a Glance
| Category | Detail |
|---|
| Condition | PD-1/PD-L1 Inhibitor Therapy |
| Key Mechanisms | Tumor-intrinsic and microenvironmental features, patient functional status and comorbidities, context of prior treatment. |
| Target Population | Patients with malignancies receiving PD-1/PD-L1 therapy. |
| Care Setting | Late-phase clinical development. |
Key Highlights
- Durable benefit from PD-1/PD-L1 therapy is limited to selected patient subgroups.
- Variability in response is influenced by multiple biological and clinical factors.
- Combination strategies with PD-1/PD-L1 inhibitors show variable clinical value and toxicity.
- A structured framework was used to evaluate late-phase clinical programs.
- 47 clinically relevant late-phase programs were identified for future development.
Guideline-Based Recommendations
Diagnosis
- Assess tumor-intrinsic and microenvironmental features.
Management
- Consider combination strategies with chemotherapy, radiotherapy, and targeted therapies.
Monitoring & Follow-up
- Evaluate clinical benefit and manage toxicity in late-phase trials.
Risks
- Toxicity and practical feasibility of combination regimens.
Patient & Prescribing Data
Patients with various malignancies undergoing PD-1/PD-L1 therapy.
Incremental clinical benefit is tested in comparative designs.
Clinical Best Practices
- Utilize a biologically grounded framework to evaluate PD-1/PD-L1 strategies.
- Prioritize late-phase programs based on exposure, effect, and manageable toxicity.
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