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When Less May Be Enough: Dose Selection Strategies for Immune Checkpoint Inhibitors Focusing on AntiPD-(L)1 Agents.

Daniel V Araujo¹, Bruno Uchoa², Juan José Soto-Castillo³

¹Department of Medical Oncology, Hospital de Base/HB Onco, FUNFARME/FAMERP, Av. Brigadeiro Faria Lima 5544, São José do Rio Preto, SP, Brazil. daniel.araujo@edu.famerp.br.

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Summary

Lower doses of anti-PD(L)-1 agents may offer similar efficacy and reduce toxicity. This review examines current dosing strategies and suggests optimizing anti-PD(L)-1 therapy for better clinical and financial outcomes.

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Multiplexed Immunofluorescence Analysis and Quantification of Intratumoral PD-1+ Tim-3+ CD8+ T Cells

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Area of Science:

Oncology
Immunotherapy
Pharmacology

Background:

Early anti-PD(L)-1 trials often didn't reach maximum tolerated dose (MTD).
Efficacy was observed at low doses, suggesting no direct dose-toxicity or dose-efficacy relationship.
High cost of anti-PD(L)-1 agents fuels debate on optimal dosing.

Purpose of the Study:

Review anti-PD(L)-1 dosing, response rates, and adverse events in early trials.
Evaluate dose selection appropriateness for Phase 2 and regulatory approval.
Examine real-world data on lower/extended dosing intervals.

Main Methods:

Literature review of early clinical trials (dose-escalation, Phase 2).
Analysis of real-world data (RWD) on anti-PD(L)-1 usage.
Discussion of clinical and financial toxicity.

Main Results:

Accumulating evidence suggests lower or extended anti-PD(L)-1 doses may yield similar clinical benefits.
Current approved doses might be higher than necessary, leading to increased toxicity.
Dosing may not follow a linear dose-response curve.

Conclusions:

Lower doses or extended intervals of anti-PD(L)-1 agents warrant further investigation.
Optimizing dosing can mitigate clinical and financial toxicity.
Future immunotherapeutic development should prioritize finding the lowest efficacious dose over MTD.