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Single-agent pembrolizumab FDA approved for the first-line treatment of stage III NSCLC with PD-L1 TPS ≥1%
By: News Feed | Last updated: 18th April 2019 | In: US FDA Onc\Haem Approvals
carboplatin, FDA, Keytruda, Merck, NSCLC, paclitaxel, PD-L1, pembrolizumab, pemetrexed, surgery, TPS
On 11 April 2019, the FDA approved single-agent pembrolizumab (Keytruda®, Merck) for the first-line treatment of stage III/IV non-small cell lung cancer (NSCLC) patients with a PD-L1 Tumor Proportion Score (TPS) ≥1% who are not amenable to surgical resection or definitive chemoradiation and who have no known EGFR or ALK genomic aberrations.
The FDA approval was based on the multicenter, open-label, active-controlled KEYNOTE‑042 (NCT02220894) study randomised 1274 stage III or IV NSCLC patients with a PD-L1 TPS ≥1% (per 22C3 antibody) in a 1:1 fashion to either receive pembrolizumab or investigator’s choice (IC) chemotherapy of carboplatin plus either pemetrexed or paclitaxel. No patients had received prior treatment for metastatic disease. Stratification factors included the ECOG performance status, histology, geographic region, and PD-L1 expression (TPS ≥50% vs. TPS 1 to 49%). The efficacy assessments included the overall survival (OS) in the TPS ≥50% and TPS ≥20% subgroups as well as the OS in the overall (TPS ≥1%) population.
In the overall (TPS ≥1%) population, pembrolizumab was associated with a median OS of 16.7 months vs 12.1 months in the IC chemotherapy arm (HR=0.81; 95% CI, 0.71-0.93; P=0.0036). In the TPS ≥20% subgroup, the median OS measured 17.7 and 13.0 months for the pembrolizumab and IC chemotherapy arms, respectively (HR=0.77; 95% CI, 0.64-0.92; P=0.004). Finally, in the TPS ≥50% subgroup, it was estimated the median OS with pembrolizumab was 20 months and 12.2 months for IC chemotherapy (HR=0.69; 95% CI, 0.56-0.85; P=0.0006). The progression-free survival and response rate were similar between the arms in all populations.
Common adverse reactions in ≥10% of patients treated with single-agent pembrolizumab in the KEYNOTE-042 included fatigue, decreased appetite, dyspnoea, cough, rash, constipation, diarrhoea, nausea, hypothyroidism, pneumonia, pyrexia, and weight loss.
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