PublishedOctober 25, 2026
JournalAnnals of Oncology
TrialPERSEE (GFPC 01-2020), randomized phase 3, NCT04547504

Adding Platinum Chemotherapy to Pembrolizumab Extends Median Progression-Free Survival (16.1 vs 6.9 Months) in PD-L1 ≥50% NSCLC, With Overall Survival Not Clearly Different and More Grade ≥3 Toxicity (54% vs 19%): The Phase 3 PERSEE Trial

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Article Summary
  • PERSEE is a multicenter, randomized phase 3 trial that compared pembrolizumab plus platinum-based chemotherapy (n = 160) with pembrolizumab alone (n = 161) as first-line treatment in 321 patients with advanced NSCLC and PD-L1 expression ≥50%. The primary endpoint, progression-free survival by blinded central review, was longer with the combination: median 16.1 months (95% CI, 11.0–34.1) vs 6.9 months (95% CI, 5.5–9.3); HR 0.56 (95% CI, 0.43–0.74); P<0.001, at a median follow-up of 38.7 months.
  • Median overall survival was 50.2 vs 29.9 months (HR 0.77; 95% CI, 0.56–1.05), a confidence interval that includes 1. Grade ≥3 treatment-related adverse events occurred in 54% vs 19% of patients. This summary is based on the published abstract only; details not in the abstract are marked as not specified in source.

Why This Study Matters

Pembrolizumab, alone or combined with platinum-based chemotherapy, is a standard first-line treatment for patients with metastatic non-small-cell lung cancer (NSCLC) without actionable oncogenic alterations and with high programmed death-ligand 1 (PD-L1) expression. PERSEE was conducted as a head-to-head comparison of these two treatment strategies.

1
Primary endpoint: median PFS 16.1 months (95% CI, 11.0–34.1) with pembrolizumab + chemotherapy vs 6.9 months (95% CI, 5.5–9.3) with pembrolizumab alone; HR 0.56 (95% CI, 0.43–0.74); P<0.001.
2
Overall survival: median OS 50.2 months vs 29.9 months; HR 0.77 (95% CI, 0.56–1.05). The confidence interval includes 1.
3
Safety: grade ≥3 treatment-related adverse events in 54% vs 19%.

Study Design

PERSEE (NCT04547504) is a multicenter, phase 3 trial. Patients were randomly assigned 1:1 and stratified by the presence of brain metastases and by histologic subtype. The primary endpoint was progression-free survival (PFS), assessed by blinded central review according to RECIST v1.1. Key secondary endpoints included overall survival (OS), objective response rate, duration of response, and safety.

The trial was open-label (masking "None") and conducted in France; Oncodaily reports 28 centers, while the ClinicalTrials.gov record lists 29 sites, so the exact number of sites is not specified in the abstract (external source: Oncodaily summaries of the paper; ClinicalTrials.gov).

Trial at a glance

321 patients randomized 1:1; median follow-up 38.7 months; pembrolizumab 200 mg every 3 weeks for up to 35 cycles; conducted in France (external source: ClinicalTrials.gov and Oncodaily).

Patient Population

Eligible patients were adults with treatment-naïve stage IV or unresectable stage III NSCLC not amenable to definitive radiotherapy and with PD-L1 expression ≥50%. A total of 321 patients underwent randomization: 160 were assigned to pembrolizumab plus chemotherapy and 161 to pembrolizumab monotherapy.

ArmnRegimen
Pembrolizumab + chemotherapy160Pembrolizumab 200 mg every 3 weeks (up to 35 cycles) with four cycles of induction chemotherapy. Non-squamous: cisplatin or carboplatin (AUC 5) plus pemetrexed, then pembrolizumab-pemetrexed maintenance. Squamous: carboplatin (AUC 6) plus paclitaxel, then pembrolizumab maintenance.
Pembrolizumab alone161Pembrolizumab 200 mg every 3 weeks, for up to 35 cycles

Primary Endpoint Results

At a median follow-up of 38.7 months, median PFS was significantly longer with combination therapy than with monotherapy.

EndpointPembrolizumab + chemoPembrolizumab aloneHR (95% CI)PSource
Median PFS (blinded central review)16.1 months (95% CI, 11.0–34.1)6.9 months (95% CI, 5.5–9.3)0.56 (0.43–0.74)<0.001Published abstract
Median OS (key secondary)50.2 months29.9 months0.77 (0.56–1.05)Not specified in sourcePublished abstract
Objective response rate77.5%50.3%Not specified in sourceNot specified in sourceExternal reporting (Oncodaily; Targeted Oncology; Lung Cancers Today)

The median OS values favor the combination numerically, but the 95% confidence interval for the OS hazard ratio (0.56–1.05) includes 1, so the abstract does not support a statistically significant OS difference.

Among patients with treatment-naïve advanced NSCLC and high PD-L1 expression, the addition of platinum-based chemotherapy to pembrolizumab significantly prolonged PFS compared with pembrolizumab monotherapy.
— Conclusion of the published abstract, Descourt et al., Ann Oncol 2026

Subgroup Analyses

The abstract does not report subgroup-level statistics. Randomization was stratified by brain metastases and histologic subtype, and the chemotherapy backbone differed by histology, but results by these subgroups are not given in the abstract.

SubgroupResult
PD-L1 expression strataNot specified in source
Brain metastases (yes/no)Not specified in source
Histology (squamous / non-squamous)Not specified in source

Safety Profile

Grade ≥3 treatment-related adverse events occurred in 54% of patients receiving the combination and 19% of those receiving pembrolizumab alone. Grade ≥3 immune-related adverse events occurred in 13% of patients in each group.

Adverse event categoryPembrolizumab + chemoPembrolizumab alone
Grade ≥3 treatment-related AEs54%19%
Grade ≥3 immune-related AEs13%13%

Interpretation and Broader Context

PERSEE meets its primary endpoint: adding platinum-based chemotherapy to pembrolizumab prolonged PFS compared with pembrolizumab alone. The trade-off is clear in the abstract: more than half of patients on the combination had a grade ≥3 treatment-related adverse event, compared with about one in five on monotherapy. Overall survival, a key secondary endpoint, was numerically longer with the combination, but its confidence interval crosses 1.

Questions the abstract leaves open include which patients gain most from chemotherapy, how outcomes differ by PD-L1 stratum, brain-metastasis status, and histology, and whether the PFS gain will translate into a confirmed survival benefit with longer follow-up. Those details would need the full publication. This article does not make treatment recommendations.

Limitations

Overall survival, a key secondary endpoint, did not show a clear difference: the 95% confidence interval of the hazard ratio (0.56–1.05) includes 1, so a survival benefit is not established by the abstract. The abstract reports no results by PD-L1 stratum, brain-metastasis status or histology, so it cannot identify which patients benefit most. The trial was open-label (external source: ClinicalTrials.gov record). This article is built from the published abstract only; full text was not accessible. ClinicalTrials.gov lists a registered enrollment figure that differs from the 321 patients randomized in the paper; this article uses the paper's figure (external source: ClinicalTrials.gov record).

Trial registration

Primary source: DOI 10.1016/j.annonc.2026.10.108 · PubMed 42927854

References

  1. Descourt R, Mogenet A, Consigny M, et al. Pembrolizumab with or without platinum-based chemotherapy as first-line treatment in advanced NSCLC expressing PD-L1 ≥50%: The PERSEE randomized phase III trial (GFPC 01-2020). Ann Oncol. 2026 Oct 25. doi: 10.1016/j.annonc.2026.10.108. PMID: 42927854.
  2. ClinicalTrials.gov: NCT04547504. Sponsor: University Hospital, Brest (external source: ClinicalTrials.gov record); funder not stated in the abstract.
  3. External sources: Oncodaily PERSEE summary; Targeted Oncology ESMO 2026 coverage; Lung Cancers Today; ClinicalTrials.gov record (MedPath mirror).