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Poster Discussion session - NSCLC, metastatic 2

4342 - Pembrolizumab in performance status 2 patients with non-small-cell lung cancer (NSCLC): results of the PePS2 trial


21 Oct 2018


Poster Discussion session - NSCLC, metastatic 2



Tumour Site


Gary Middleton


Annals of Oncology (2018) 29 (suppl_8): viii493-viii547. 10.1093/annonc/mdy292


G. Middleton1, K. Brock2, Y. Summers3, J. Connibear4, R. Shah5, C. Ottensmeier6, P. Shaw7, S. Ming-Lee8, S. Popat9, C. Barrie10, G. Barone11, R. Mant2, J.S. Savage2, L. Billingham2

Author affiliations

  • 1 Institute Of Immunology And Immunotherapy, University of Birmingham, B15 2TT - Birmingham/GB
  • 2 Cancer Research Uk Clinical Trials Unit, University of Birmingham, B15 2TT - Birmingham/GB
  • 3 The Christie, The Christie NHS Foundation Trust, M20 4BX - Manchester/GB
  • 4 St Bartholomew's Hospital, Barts Health NHS Trust, London/GB
  • 5 Maidstone Hospital, Maidstone and Tumbridge Wells NHS Trust, Maidstone/GB
  • 6 Southampton General Hospital, University Hospital Southampton NHS Foundation Trust, SO16 6YD - Southampton/GB
  • 7 Velindre Cancer Centre, Velindre NHS Trust, CF14 2TL - Cardiff/GB
  • 8 University College Hospital, University College London Hospitals NHS Foundation Trust, NW1 2BU - London/GB
  • 9 The Royal Marsden Hospital, The Royal Marsden NHS Foundation Trust, SW3 6JJ - London/GB
  • 10 Western General Hospital, NHS Lothian, EH4 2XU - Edinburgh/GB
  • 11 Lincoln County Hospital, United Lincolnshire Hospitals NHS Trust, LN2 5QY - Lincoln/GB


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Abstract 4342


Many patients with advanced NSCLC present with a performance status (PS) of 2. All published immunotherapy data in NSCLC is in PS0-1 patients whilst its safety and activity in this important patient group is unknown.


Between 4/1/2017 and 13/2/2018 the trial recruited 62 PS2 NSCLC patients. PS was assessed by the registering physician on several occasions prior to trial entry to ensure a bona fide PS2 population. Components of the ECOG PS2 criteria were incorporated into the exclusion/inclusion criteria. Previous therapy and PD-L1 status were recorded at baseline. Co-primary outcomes were: i) durable clinical benefit (DCB) defined as complete or partial response or stable disease at 18 weeks; and ii) toxicity defined as treatment-related dose delay or discontinuation due to adverse event (AE).


Median age 72 yrs (range 43-86), median follow-up 249 days. 60 patients commenced therapy and were evaluable. Co-primary outcomes, objective response rate (ORR) and progression-free survival (PFS) are presented below. 3/18 responders have relapsed, after 67, 201 and 287 days. 23 patients (38%) had grade 3/4 AE by CTCAE v4, 5 (8%) had such an event thought possibly related to pembrolizumab. Of potentially immune-related AEs: 7 patients (12%) reported acneiform/maculopapular rash (6 G1/2; 1 G3); 2 (3%) pruritus (1 each G1 and 2); 1 (2%) G3 vasculitis; 1 (2%) G3 pneumonitis; 1 (2%) G1 colitis; 1 (2%) G1 hyperthroidism; 4 (7%) hypothyroidism (1 G1, 3 G2); 1 (2%) G3 arthralgia. There were no obvious cases of hyperprogression.Table: 1384PD

DCB (%)ORR (%)Median PFS monthsToxicity (%)
All (n = 60)20 (33)18 (30)4.48 (13)
Previous therapy:
No (n = 9)1 (11)0 (0)1.92 (22)
Yes (n = 50)19 (38)18 (36)4.66 (12)
Missing (n = 1)0 (0)0 (0)0 (0)
< 1% (n = 27)6 (22)5 (19)3.34 (15)
1-49% (n = 15)5 (33)5 (33)6.80 (0)
≥ 50% (n = 15)8 (53)7 (47)8.53 (20)
Missing (n = 3)1 (33)1 (33)1 (33)


This is the first prospective analysis of pembrolizumab in a rigorously assessed PS2 population. Pembrolizumab can be delivered safely to such patients providing levels of activity at least equivalent to a PS0-1 population. The trial demonstrates that pembrolizumab is a safe, effective therapy for this difficult to treat NSCLC population.

Clinical trial identification

ISRCTN10047797, EudraCT: 2015-002241-55; NCT02733159.

Legal entity responsible for the study

University of Birmingham.


Merck Sharp & Dohme.

Editorial Acknowledgement


G. Middleton: Consultant: Roche, BI, BMS, MSD; Speaker’s bureau: MSD, BMS, Roche, Eli Lilly; Grant/Research support: Plexxikon, KAEL-GemVax, BMS, MSD; Honoraria: Roche, BI, BMS, MSD, Eli Lilly. K. Brock: Travel, accommodations, expenses: Merck Sharp & Dohme, Roche; Shares: AstraZeneca, GlaxoSmithKline. Y. Summers: Advisory board role: MSD, Pfizer, AZ, BMS, Takeda, Roche, BI. R. Shah: Advisory boards and speaker events: MSD. C. Ottensmeier: Consulting or advisory role: Bristol-Myers Squibb, Merck Sharp & Dohme, Immatics; Speakers' bureau: Bristol-Myers Squibb, Merck Sharp & Dohme, Roche; Research funding: Bristol-Myers Squibb, Verastem, Merck Sharp & Dohme, Inovio Pharmaceuticals, BioNTech AG, Serametrix, Touchlight Genetics, Delcath Systems; Travel, accommodations, expenses: Bristol-Myers Squibb, Merck Sharp & Dohme, Roche, Delcath Systems; Other relationship: Transgene. S. Popat: Honoraria: Boehringer Ingelheim, AstraZeneca, Roche, Takeda, Chugai Pharma; Consulting or advisory role: Boehringer Ingelheim, Roche, Novartis, Pfizer, AstraZeneca, Bristol-Myers Squibb, MSD, Guardant Health, Abbvie; Research funding: Boehringer Ingelheim, Epizyme, Bristol-Myers Squibb, Clovis Oncology, Roche, Lilly, Takeda; Travel, accommodations, expenses: Boehringer Ingelheim, Bristol-Myers Squibb, Merck Sharp & Dohme. G. Barone: Consultant/advisor: Bristol-Myers Squibb; Travel and accommodation funding: Roche, Pfizer, Eli Lilly, Eisai. L. Billingham: Honoraria: Eli Lilly, Pfizer, Roche, Celgene, AstraZeneca. All other authors have declared no conflicts of interest.

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