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Related Concept Videos

Impact of Pharmacokinetic–Pharmacodynamic Models: Regulatory Decisions01:15

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PK–PD modeling has significantly influenced FDA regulatory decisions, particularly drug approval, dosage optimization, and labeling. These models integrate pharmacokinetics (PK) and pharmacodynamics (PD) to predict drug behavior and effects, aiding in optimizing dosing regimens and enhancing the probability of clinical trial success.One notable example is Nesiritide (Natrecor®), a recombinant human brain natriuretic peptide for treating acute decompensated congestive heart failure...
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Related Experiment Video

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Multiplexed Immunofluorescence Analysis and Quantification of Intratumoral PD-1+ Tim-3+ CD8+ T Cells
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Second-event endpoints (EFS2, PRFS2 and PFS2) after anti-PD-(L)1-based RCTs: a systematic review and meta-analysis.

Pablo Jimenez1,2,3, Oriol Mirallas3,4,5, Ana Martin Quesada6,7

  • 1Head and Neck Unit, The Royal Marsden NHS Foundation Trust, London, UK pablojimenez.pjl@gmail.com.

Journal for Immunotherapy of Cancer
|November 28, 2025
PubMed
Summary

Early use of anti-PD-(L)1 immunotherapy significantly improves long-term outcomes in solid tumors. Event-free survival 2 (EFS2), progression/recurrence-free survival 2 (PRFS2), and progression-free survival 2 (PFS2) are strong surrogates for overall survival (OS).

Keywords:
Immune Checkpoint InhibitorImmunotherapySolid tumor

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Area of Science:

  • Oncology
  • Immunotherapy
  • Clinical Trials

Background:

  • Immune checkpoint inhibitors (ICIs), especially anti-PD-(L)1 therapies, have revolutionized cancer treatment.
  • Novel endpoints like EFS2, PRFS2, and PFS2 offer a more accurate assessment of durable clinical benefit compared to traditional first-event metrics.
  • This study evaluates the impact of early anti-PD-(L)1 use and the validity of these long-term endpoints in solid tumors.

Purpose of the Study:

  • To review the magnitude of benefit from early anti-PD-(L)1 therapy in solid malignancies.
  • To assess the long-term endpoints (EFS2, PRFS2, PFS2) as reliable surrogates for overall survival (OS) in cancer immunotherapy.
  • To inform clinical decision-making and regulatory evaluations regarding immunotherapy efficacy.

Main Methods:

  • A systematic review and meta-analysis of anti-PD-(L)1 based randomized controlled trials (RCTs) in solid tumors was conducted.
  • Data from 47 RCTs (34,973 patients) were analyzed, focusing on EFS2, PRFS2, PFS2, and OS.
  • Statistical analyses included random-effects meta-analysis and linear regression to compare endpoint correlations.

Main Results:

  • Early anti-PD-(L)1 use significantly improved EFS2/PRFS2/PFS2 (HR 0.72), with consistent benefits across settings and tumor types (e.g., NSCLC, MSI-high).
  • EFS2/PRFS2/PFS2 demonstrated a strong correlation with OS (R²=0.74 overall, R²=0.86 in NSCLC), outperforming traditional PFS/DFS (R²=0.39 overall, R²=0.65 in NSCLC).
  • Anti-PD-(L)1s showed reduced efficacy as subsequent therapy in non-ICI-experienced patients.

Conclusions:

  • Early administration of anti-PD-(L)1 therapy prolongs disease control and may enhance subsequent treatment response.
  • EFS2, PRFS2, and PFS2 are validated as robust surrogates for OS in immunotherapy trials.
  • These long-term endpoints should be routinely incorporated into immunotherapy RCTs to better capture durable benefits.