407P - Pembrolizumab Expanded Access Program (EAP) in Taiwan for patients with progressive advanced melanoma after prior ipilimumab treatment

Date 18 December 2016
Event ESMO Asia 2016 Congress
Session Poster lunch
Topics Immunotherapy
Skin cancers
Presenter Chang-Keng Yang
Citation Annals of Oncology (2016) 27 (suppl_9): ix126-ix129. 10.1093/annonc/mdw589
Authors C. Yang1, J. Liu2, C. Lin3, T. Liu4, P. Cheng5, C. Lin6, H. Hu7, C. Cao8, W. Huang8, L. Chen9, W. Chang1
  • 1Oncology, Chang Gung Memorial Hospital-Linkou, 333 - Taoyuan/TW
  • 2Oncology, Taipei Veterans General Hospital, 11217 - Taipei/TW
  • 3Oncology, National Taiwan University Hospital, 10002 - Taipei/TW
  • 4Oncology, Chung-Ho Memorial Hospital,Kaohsiung Medical University Hospital, 807 - Kaohsiung/TW
  • 5Medical Oncology, Chiayi Chang Gung Memorial Hospital, 613 - Puzi City/TW
  • 6Oncology, China Medical University Hospital, 404 - Taichung/TW
  • 7Oncology, Koo Foundation Sun Yat Sen Cancer Center, 112 - Taipei/TW
  • 8Oncology, Liouying Chi-Mei Hospital, 736 - Tainan/TW
  • 9Oncology, Cathay General Hospital, 106 - Taipei/TW



Pembrolizumab, a programmed death 1 (PD-1) inhibitor, has been approved for treatment of advanced melanoma based on a significant survival improvement in patients who are refractory to other treatments and as the first line treatment. We evaluated the clinical activity of pembrolizumab in melanoma patients in Taiwan under the expanded access program.


From December 2014 through June 2016, we enrolled patients with progressive unresectable stage III/IV melanoma, who have previously received ipilimumab and BRAF/MEK inhibitors if BRAF mutation. Pembrolizumab was given at 2 mg/kg every three weeks continuously until development of intolerable side effects or progression of disease per study protocol’s designation.


Data were collected from 23 advanced melanoma patients (15 cutaneous, 6 mucosal and 2 of unknown primary). 20 patients (61%) received at least 2 lines of treatment previously, and 6 patients (26%) with stable brain metastases were enrolled. Median overall survival (OS) was 6.7 months (CI 95% 4.6-8.8). 12-month OS was 38% and 15-month OS was 30%. Among 20 evaluable patients, 4 patients achieved a partial response, and 8 patients achieved a stable disease, with an overall response rate of 20.0% (CI 95% 0-39%) and clinical benefit rate of 60% (CI 95% 36-84%). The most common drug-related adverse events of any grade were rash (35%), pruritus (30%), and fatigue (30%). Two deaths were considered treatment-related; one cytokine storm and one ventricular tachycardia.


Pembrolizumab’s activity in melanoma as a second line immune checkpoint inhibitor (after prior exposure of ipilimumab) was confirmed in Taiwan. Durable response, even in the previously heavily-treated patients, has been observed.

Clinical trial indentification

Legal entity responsible for the study

MSD Taiwan


MSD Taiwan


All authors have declared no conflicts of interest.