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Keytruda® FDA approved for recurrent and metastatic Merkel cell carcinoma
By: Stijn van den Borne, MSc | Last updated: 14 January 2019 | In: US FDA Onc\Haem Approvals, Oncology, Melanoma & Skin Cancer, Immunotherapy
Article Keywords
MCC, paediatric, Keytruda, Oncology, pembrolizumab, Merck, FDA
On 19 December 2018, pembrolizumab (Keytruda®, Merck) received accelerated approval by the FDA for the treatment of recurrent locally advanced or metastatic (R/M) Merkel cell carcinoma (MCC) in adult and paediatric patients.
CITN-09/KEYNOTE-017
The multicentre, non-randomised, open-label Cancer Immunotherapy Trials Network protocol 9 (CITN-09) or KEYNOTE-017 trial (NCT02267603), enrolled 50 R/M MCC patients who did not receive prior systemic therapy for advanced disease. The endpoints included the overall response rate (ORR) and the duration of response (DoR) by blinded independent central review (BICR) and per RECIST 1.1.
The complete response rate was 24% and the ORR measured 56% (28/50; 95% CI, 41-70). The median DoR had not yet been reached, however, a DoR greater than 6 months was observed in 96% of responders and a DoR greater than 12 months was observed in 54% of responders.
Safety
Common adverse reactions reported in ≥20% of patients receiving single-agent pembrolizumab included fatigue, musculoskeletal pain, decreased appetite, pruritus, diarrhoea, nausea, rash, pyrexia, cough, dyspnoea, constipation, pain, and abdominal pain.
Disclaimer
This article is not medical advice. Patients should seek personal assessment by a licenced specialist. Physicians are recommended to read the full publication(s) as cited in the article before making medical decisions. This article does not supersede nor replace the published article(s).
© Copyright 2018 MediPaper Medical Communications Ltd.
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© Copyright 2018 MediPaper Medical Communications Ltd.
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