Three-year overall survival for patients with advanced melanoma treated with pembrolizumab in KEYNOTE-001

P. Manders, A. M. Joshua, T. C. Gangadhar, R. Joseph, R. Dronca, A. Patnaik, H. Zarour, P. Hersey, X. N. Li, S. J. Diede, S. Ebbinghaus, F. S. Hodi, R. Kefford, C. Robert, A. Ribas, O. Hamid, A. Daud, J. D. Wolchok, W.-J. Hwu, J. S. Weber

Research output: Contribution to journalMeeting abstract


Background: Pembrolizumab demonstrated superior PFS over chemotherapy for ipilimumab-refractory melanoma (KEYNOTE-002) and superior OS and PFS over ipilimumab for advanced melanoma (KEYNOTE-006). Here we present 3-year OS data for all patients with melanoma enrolled in the phase 1b KEYNOTE-001 study (NCT01295827). Methods: Patients enrolled in ipilimumab-naive and ipilimumab-treated cohorts received pembrolizumab 2 or 10 mg/kg Q3W or 10 mg/kg Q2W. Response was assessed by RECIST v1.1 every 12 weeks. OS was estimated using the Kaplan–Meier method. Results: Of the 655 patients enrolled, 24% had BRAFV600 mutation, 78% had stage M1c disease, 38% had elevated lactate dehydrogenase, 75% had ≥1 prior therapy, and 52% had prior ipilimumab. As of the September 18, 2015 data cut off date, median follow-up was 32 months (range 24–46) and 358 (55%) patients had died. The 36-month OS rate was 40% and median OS was 23.8 months (95% CI, 20.2–29.0), with similar results for each dose (Table). Note that 36-month OS rates were 41% in both ipilimumabtreated and ipilimumab-naive patients and 45% in treatment-naive patients (Table). Examination of the OS curve suggests a long-term OS benefit for a fraction of patients treated with pembrolizumab. Additional data, including PFS, ORR, duration of response and safety, will be available for presentation. Conclusions: Pembrolizumab provides long-term survival benefit in patients with ipilimumab-naive and ipilimumab-treated advanced melanoma, with ~40% of patients alive at 3 years. These data support the use of pembrolizumab in patients with advanced melanoma regardless of prior treatment.
Original languageEnglish
Pages (from-to)47-48
Number of pages2
JournalAsia-Pacific journal of clinical oncology, volume 12 supplement 4 : Medical Oncology Group of Australia incorporated annual scientific meeting : program and abstracts
Publication statusPublished - Aug 2016
EventMedical Oncology Group of Australia Incorporated Annual Scientific Meeting - Gold Coast, QLD
Duration: 3 Aug 20165 Aug 2016


Dive into the research topics of 'Three-year overall survival for patients with advanced melanoma treated with pembrolizumab in KEYNOTE-001'. Together they form a unique fingerprint.

Cite this