This study looked at people with advanced non-small-cell lung cancer whose tumours had high levels of a protein called PD-L1 (at least 50%). The immunotherapy drug pembrolizumab was compared with chemotherapy. Patients who received pembrolizumab went longer without their disease getting worse and lived longer. Treatment-related side effects were also less common in this group.
Metastatic NSCLC with PD-L1 TPS ≥50%, without EGFR or ALK alterations; first-line; ECOG 0–1
| Drug | Dose | Route | Schedule |
|---|---|---|---|
| Pembrolizumab | 200 mg every 3 weeks or 400 mg every 6 weeks | IV (30 min) | Day 1 |
Source: FDA label; 5-year results.
On the page “Lung cancer” · Advanced NSCLC without a driver alteration: first-line
Advanced non-small cell lung cancer, PD-L1 50% or more
| Drug | Dose | Route | Schedule |
|---|---|---|---|
| Pembrolizumab | 200 mg every 3 weeks (or 400 mg every 6 weeks) | IV | Day 1 |
As in KEYNOTE-024; dose source:.
On the page “Pembrolizumab alone in lung cancer with high PD-L1 (KEYNOTE-024)”
Doses follow the trial protocol, guideline or official drug label (source given in the notes of each regimen). Before prescribing, check blood counts, renal and hepatic function, drug interactions and the patient’s condition, and adjust the dose according to the drug label.
Pembrolizumab 200 mg (flat dose) IV infusion, day 1 of each 21-day cycle, up to 35 cycles (about 2 years) or until disease progression or unacceptable toxicity (154 patients).
One of the following regimens at the investigator's choice, all IV in 21-day cycles for 4 to 6 cycles (151 patients):
Crossover to pembrolizumab was allowed on disease progression.
Source of the regimen details: ClinicalTrials.gov NCT02142738 (description of arms) and the FDA label for Keytruda (DailyMed, section 14, KEYNOTE-024); the full text of the NEJM paper was not available in PMC.
Doses are given for the information of specialists, as in this study’s protocol, and are not a prescription. Every drug must be prescribed by the treating physician for the individual patient.
Adults with stage IV non-small-cell lung cancer (NSCLC) with no prior systemic therapy for metastatic disease, with PD-L1 expression on at least 50% of tumour cells (TPS 50% or higher with the PD-L1 IHC 22C3 pharmDx assay at a central laboratory), without a sensitising EGFR mutation or ALK translocation, with ECOG performance status 0 or 1, at least one measurable lesion per RECIST 1.1, life expectancy of at least 3 months and adequate organ function. Prior neoadjuvant/adjuvant chemotherapy was allowed if completed at least 6 months before the diagnosis of metastatic disease.
Key exclusion criteria: untreated central nervous system metastases or carcinomatous meningitis, active autoimmune disease requiring systemic treatment in the past 2 years, history of pneumonitis or interstitial lung disease requiring corticosteroids, systemic corticosteroids within 3 days before starting or any other immunosuppressive drug, thoracic radiotherapy of more than 30 Gy within the past 6 months, prior treatment with immune checkpoint inhibitors, HIV, active hepatitis B or C.
Primary endpoint: progression-free survival (PFS) assessed by blinded, independent, central radiological review. Secondary endpoints: overall survival, objective response rate and safety.
Treatment-related adverse events of any grade were less frequent in the pembrolizumab group (73.4% versus 90.0%). Treatment-related grade 3, 4 or 5 adverse events were also less frequent (26.6% versus 53.3%). Details of immune-related adverse events are not given in the abstract.
According to the abstract, in patients with untreated advanced NSCLC with PD-L1 expression on at least 50% of tumour cells and without EGFR mutation or ALK translocation, pembrolizumab gave better progression-free and overall survival and fewer adverse events than platinum-based chemotherapy. The status of drug approvals and guideline recommendations should be checked in up-to-date sources.
The trial was open-label. Crossover from the chemotherapy group to pembrolizumab was allowed on disease progression. The results apply only to patients with PD-L1 expression on at least 50% of tumour cells and without EGFR mutation or ALK translocation. The study was funded by Merck.
This summary was prepared by the editorial team from the published paper; the original paper is the final reference. Read the original abstract on PubMed.
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