5-Year Survival Benefit in NSCLC Patients!

Discover the groundbreaking real-world study on Pembrolizumab for non-small cell lung cancer (NSCLC)!

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Pembrolizumab offered long-term efficacy in patients with non-small cell lung cancer (NSCLC), as shown by a 5-year survival rate of 26.9 months.  

Key Findings:

• NSCLC patients treated with pembrolizumab had a 5-year survival of 26.9 months and a median overall survival (OS) of 21.8 months.
• The Eastern Cooperative Oncology Group-performance status (ECOG-PS), age, and programmed cell death-ligand 1 (PD-L1) tumor proportion score (TPS) predicted survival in pembrolizumab-treated NSCLC patients.
• Survival rate and progression-free survival were similar between the study population and the KEYNOTE-024 (KN024) look-alike cohort. 
• The 5-year survival rate was the longest in those who discontinued treatment due to completion. 
• Real-world immune-related adverse events (rw-irAEs) affected 43.8% of patients. 

Introduction: Real-World Data on Pembrolizumab’s Long-Term Efficacy Is Limited

Pembrolizumab is a front-line treatment for advanced NSCLC with a PD-L1 TPS of ≥ 50%. However, there is scarce real-world evidence of the long-term efficacy of PD-L1 inhibitor monotherapy in NSCLC patients with a high PD-L1 expression.

To address this knowledge gap, a study published in the Journal for ImmunoTherapy for Cancer assessed the 5-year outcomes of a real-world cohort of patients with advanced NSCLC and PD-L1 TPS ≥ 50% who received first-line pembrolizumab monotherapy.

Methodology: Cohort Study 

This study assessed the 5-year outcomes of 1,050 patients from 61 institutions across 14 countries (referred to as Pembro-real 5Y). Individual patient-level data (IPD) were also extracted from the KN024 trial experimental arm to compare the long-term outcomes of the two cohorts. The researchers also created a “KN024 look-alike” cohort by excluding patients with

an Eastern Cooperative Oncology Group-performance status (ECOGPS) status of ≥ 2 to assess the reproducibility of clinical trial results. Conditional inference tree analysis was performed to provide a hierarchical organization of long-term benefit determinants.

Results:

• 5-Year Survival Rate and Median OS Were 26.9 and 21.8 Months, Respectively

At the 5-year landmark, 282 patients were alive, resulting in a 5-year survival rate of 26.9%. The median overall survival (OS) was 21.8 months (95% confidence interval (CI): 19.1–25.7, 805 events), while the real-world progression-free survival (rw-PFS) was 10.4 months (95% CI: 8.5–11.8, 862 events). The overall response rate (ORR) was 49.6% (95% CI: 45.2%–54.2%).

Of 962 evaluable patients, 59 experienced a complete response to treatment (6.1%, 95% CI: 4.6%–7.9%). At the data cut-off, 32 patients (54.2%) were progression-free.

• The Strongest Survival Predictors Were ECOG-PS, Age, and PD-L1 TPS

Conditional inference tree analysis showed that ECOG-PS was the strongest determinant for an increased risk of death (p < 0.001), as those with poor PS only had a 5-year survival rate of 12.7% (95% CI: 7.9%–20.3%).

Among patients with an ECOG-PS 0–1, the second determinant was age (p = 0.024), with those aged < 70 years having a 5-year survival rate of 33.8% (95% CI: 28.1%–40.2%).

Patients with an ECOG-PS 0–1, aged ≥ 70 years, and a PD-L1 tumor proportion score (TPS) between 50% and 89% had a 5-year survival rate of 18.6% (95% CI: 13.1%–25.6%). The 5-year survival rate for patients with a PD-L1 TPS ≥ 90% was 33.7% (95% CI: 22.9%–47.8%) (p = 0.028).

• KN024 Look-Alike Cohort Survival Rate, PFS Similar to Overall Study Population

• Real-World Immune-Related Adverse Events Affected 43.8% of Patients

Conclusion: Pembrolizumab Offers Real-World, Long-Term Efficacy 

This real-world study substantiated the long-term efficacy of pembrolizumab, a finding that was also observed in the KN024 trial, while emphasizing the broader demographics and other challenges present in real-world practice. The analysis also showed the hierarchical role of baseline clinicopathological factors, with ECOG-PS being the most significant predator of treatment benefit, followed by age and PD-L1 expression.

Source:

Cortellini, A., Brunetti, L., Di Fazio, G. R., Garbo, E., Pinato, D. J., Naidoo, J., Katz, A., Loza, M., Neal, J. W., Genova, C., Gettinger, S., Kim, S. Y., Jayakrishnan, R., Zarif, T. E., Russano, M., Pecci, F., Federico, A. D., Awad, M., Alessi, J. V., . . . Hejleh, T. A. (2025). Determinants of 5-year survival in patients with advanced NSCLC with PD-L1≥50% treated with first-line pembrolizumab outside of clinical trials: Results from the Pembro-real 5Y global registry. Journal for Immunotherapy of Cancer, 13(2), e010674. https://doi.org/10.1136/jitc-2024-010674

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