Real-world outcomes with pembrolizumab in patients with treatment-naive advanced/metastatic NSCLC in the UK: multicentre retrospective observational study
Blackhall, Fiona H
Summers, Yvonne J
AffiliationLung Oncology, Royal Marsden Hospital, London, United Kingdom,
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AbstractIntroduction: Anti-PD1 inhibitor pembrolizumab became standard of care therapy for previously untreated advanced/metastatic NSCLC with PD-L1 ≥50% following publication of results from KEYNOTE-001 and KEYNOTE-024 trials, having demonstrated improved overall survival and tolerability over chemotherapy. We evaluated the realworld efficacy and tolerability of first-line pembrolizumab in UK patients. Methods: Multicentre retrospective observational study. Primary endpoint: progression-free survival (PFS). Key secondary endpoints: time to PD-L1 report, overall survival (OS), objective response rate (ORR), prognostic factors associated with PFS and OS, and treatmentrelated toxicities. Results: 219 patients treated with first-line pembrolizumab between 07/2016 and 01/2018 at 27 centres were included (Table 1). Median time from diagnosis of advanced disease to PDL1 report was 18 days. Median time from PD-L1 report to start of pembrolizumab treatment was 23 days. After median follow-up of 5.7 months, there were 90 events of progression or death. ORR was 56.6% (KN-024: 44.8%) with disease-control rate of 76.4%. Median PFS was 8.2 months (KN-024: 10.3mo). 20 patients continued pembrolizumab beyond first documented progression, with median time to further PD of 2.8 months. Median OS was not reached (KN- 024: NR; KN-001: 35mo). 6-month and 1-year OS rates were 73.8% (KN-024: 80.2%) and 68.2% (KN-024: 70.3%), respectively. In the multivariate analysis, poor performance status and presence of a confirmed mutation or unknown mutational status were associated with increased risk of death (p=0.024 and p=0.044). 22.8% patients experienced grade ≥3 treatment-related toxicity (KN-024; 26.6%). 38% experienced any-grade immune-related toxicities (KN-024: 29.2%), the most common being hypothyroidism (7.3%), rash (5.9%) and hyperthyroidism (3.7%). 77 patients (35.2%) required a dose delay and 58 (26.5%) required immunosuppressant therapy.Conclusion: Real-world efficacy and safety of first-line pembrolizumab are comparable to published trial data. Prolonged times to PD-L1 report and start of pembrolizumab treatment likely reflect complex access routes prior to UK NICE approval.
CitationTokaca N, Gomes F, Lau S, Jackson A, Gradwell M, Gyi M, et al. Real-world outcomes with pembrolizumab in patients with treatment-naive advanced/metastatic NSCLC in the UK: multicentre retrospective observational study. Lung Cancer. 2019;127:S33-S4.
TypeMeetings and Proceedings