Outcomes by line of therapy and programmed death ligand 1 expression in patients with advanced melanoma treated with pembrolizumab or ipilimumab in KEYNOTE-006: A randomised clinical trial - PubMed (original) (raw)

Clinical Trial

doi: 10.1016/j.ejca.2018.06.034. Epub 2018 Aug 7.

Georgina V Long 2, Dirk Schadendorf 3, Caroline Robert 4, Antoni Ribas 5, Erika Richtig 6, Marta Nyakas 7, Christian Caglevic 8, Ahmed Tarhini 9, Christian Blank 10, Christoph Hoeller 11, Gil Bar-Sela 12, Catherine Barrow 13, Pascal Wolter 14, Honghong Zhou 15, Kenneth Emancipator 16, Erin H Jensen 17, Scot Ebbinghaus 18, Nageatte Ibrahim 19, Adil Daud 20

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Clinical Trial

Outcomes by line of therapy and programmed death ligand 1 expression in patients with advanced melanoma treated with pembrolizumab or ipilimumab in KEYNOTE-006: A randomised clinical trial

Matteo S Carlino et al. Eur J Cancer. 2018 Sep.

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Abstract

Background: Predictive biomarkers of patients likely to benefit from anti-programmed death 1 inhibitor therapy have clinical relevance. We examined whether line of therapy or tumour programmed death ligand 1 (PD-L1) expression affects the efficacy and safety of pembrolizumab, compared with ipilimumab, in advanced melanoma.

Methods: Of 834 patients enrolled in the randomised, open-label phase III KEYNOTE-006 study, 833 were included in this analysis. Patients were randomly assigned 1:1:1 to receive pembrolizumab 10 mg/kg every 2 or 3 weeks (for 24 months) or ipilimumab 3 mg/kg every 3 weeks (for four doses) until disease progression/intolerable toxicity. This analysis evaluated progression-free survival (PFS), overall survival (OS) and objective response rate (ORR). Data cut-off: 03 November 2016.

Results: Of the patients, 60.3% were male, 65.9% were treatment naive and 80.6% had PD-L1-positive tumours (median follow-up was 33.9 months). Twenty-four-month survival rates were higher with pembrolizumab than with ipilimumab in treatment-naive (PFS 31.0% versus 14.6%; OS 58.0% versus 44.7%) and previously treated patients (PFS 25.7% versus 11.3%; OS 49.2% versus 37.9%). Twenty-four-month survival rates were higher with pembrolizumab than with ipilimumab in patients with PD-L1-positive tumours (PFS 33.2% versus 13.1%; OS 58.4% versus 45.0%) and similar in PD-L1-negative tumours (PFS 14.9% versus NR [no data at 24 months for a PFS estimate]; OS 43.6% versus 31.8%). Safety of pembrolizumab by subgroup was consistent with previous reports.

Conclusions: Findings support pembrolizumab monotherapy as standard of care in patients with advanced melanoma, regardless of first- or second-line therapy or PD-L1 status. CLINICALTRIALS.

Gov identifier: NCT01866319.

Keywords: Melanoma; PD-1; PD-L1; Pembrolizumab.

Copyright © 2018 Elsevier Ltd. All rights reserved.

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