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Real-world outcomes with pembrolizumab in patients with treatment-naive advanced/metastatic NSCLC in the UK: multicentre retrospective observational study
Tokaca, N. Gomes, Fabio Lau, S. Jackson, A. Gradwell, M. Gyi, M. Reinius, M. Valentine, E. Winn, E. Bhosle, J.
Tokaca, N.
Gomes, Fabio
Lau, S.
Jackson, A.
Gradwell, M.
Gyi, M.
Reinius, M.
Valentine, E.
Winn, E.
Bhosle, J.
Citations
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Abstract
Introduction: 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.
Authors
Tokaca, N.
Gomes, Fabio
Lau, S.
Jackson, A.
Gradwell, M.
Gyi, M.
Reinius, M.
Valentine, E.
Winn, E.
Bhosle, J.
O'Brien, M.
Yousaf, N.
Blackhall, Fiona H
Gilligan, D.
Treece, S.
Yip, K.
Geldart, T.
Baluch, S.
Gulliford, T.
Muthuramalingam, S.
Dancey, G.
Britten, A.
Brock, J.
Stokoe, J.
Jain, P.
Franks, K.
Toy, E.
Newsom-Davis, T.
Khan, O.
Greystoke, A.
Ali, C.
Leonard, P.
Summers, Yvonne J
Popat, S.
Gomes, Fabio
Lau, S.
Jackson, A.
Gradwell, M.
Gyi, M.
Reinius, M.
Valentine, E.
Winn, E.
Bhosle, J.
O'Brien, M.
Yousaf, N.
Blackhall, Fiona H
Gilligan, D.
Treece, S.
Yip, K.
Geldart, T.
Baluch, S.
Gulliford, T.
Muthuramalingam, S.
Dancey, G.
Britten, A.
Brock, J.
Stokoe, J.
Jain, P.
Franks, K.
Toy, E.
Newsom-Davis, T.
Khan, O.
Greystoke, A.
Ali, C.
Leonard, P.
Summers, Yvonne J
Popat, S.
Description
Date
2019
Publisher
Collections
Keywords
Type
Meetings and Proceedings
Citation
Tokaca 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.