CP-004 Analysis of treatment with pembrolizumab in patients with metastatic melanoma in the expanded access programme (EAP). (14th February 2016)

• Record Type: Journal Article
• Authors: Togliardi, E; Lanzo, G; Antonacci, G; Langella, R; Costanza, C Della; Saibene, G
• Is Part Of: European journal of hospital pharmacy. Volume 23(2016)Supplement 1
• Page Start: A2
• Page End: A2
• Publication Date: 2016-02-14
• Subjects: Pharmacy -- Periodicals; Hospital pharmacies -- Periodicals; 615.1
• DOI: 10.1136/ejhpharm-2016-000875.4
• Languages: English
• ISSNs: 2047-9956

Abstract

Abstract : Background: Metastatic melanoma was an 'orphan drug' pathology until a few years ago. But in the past years research has produced new therapeutic options, among them pembrolizumab. So an expanded access programme for patients (pt) with metastatic melanoma in PD after therapy with ipilimumab has been started Purpose: Analysis of the treated sample in terms of characteristics, and effectiveness and safety. Material and methods: Evaluation of pt treated from June 2014 to May 2015, creating a database in Excel to collect and analyse data consulting drug accountability and electronic medical records. Results: The requests for activation were 50; 35 of these (70%) were treated with pembrolizumab 2 mg/kg Q3W until progression, 15 (30%) did not enter the programme (7 died before starting the treatment, 3 were in declined health status, 3 moved to another hospital and 2 enrolled in another trial). Among the pt treated, mean age was 60 (range 17–83) years; 63% were male, 37% female, 8 (23%) died from causes not drug related, 3 (8%) interrupted treatment because of a decline in general conditions, 8 (23%) interrupted for PD and 16 (46%) are carrying on the treatment. The mean duration of treatment was 5.1 cycles (range 1–15), about 4 months. 2 patients developed PD within the third cycle whereas 9 (26% of enrolled patients) have already received more than 5 cycles. 3 pt have received only 1 cycle as they have just been enrolled in the programme. 6 (17%) of the treated pt experienced an adverse reaction (2 diarrhoea, 2 cutaneous rash, 1 thrombocytopenia and 1 elevated transaminase level). Conclusion: Although this is an interim analysis on a restricted sample, the results are essentially in line with those obtained in clinical studies. In fact, 46% of pt responded to the therapy and the drug was well tolerated. 31% of pt interrupted the treatment in advance because of a sharp decline in general condition; only 23% for PD. Pt will be kept under observation because it is important to value the long term results, especially considering that pembrolizumab will imminently be available in UE clinical practice References and/or Acknowledgements: EAP pembrolizumab in metastatic melanoma No conflict of interest.