Pembrolizumab (PEM), a humanized antibody targeting programmed death-1 receptor, has been approved by FDA for the treatment of patients (pts) with advanced melanoma (AM) in the US for over 3 years. The study examined the real-world (RW) use of PEM and associated patient (pt) outcomes in the US Oncology Clinical Practices.
Flatiron Health longitudinal database was used to identify adult pts with AM who received ≥1 dose of PEM between September 4, 2014 and December 31, 2016. These pts were followed up to December 31, 2017. Pts in clinical trials were excluded. Pt demographic, treatment, and clinical characteristics were described. Time on treatment (ToT) and overall survival (OS) were analyzed using the Kaplan Meier (KM) method, with the first dose of any PEM as the starting point.
Five hundred and thirty-two patients were included in the analysis. Of the 532 patients, 315 in first line (1L), 152 second line (2L), and 65 third line or beyond (3L+). Overall, median age at PEM initiation was 68 years (range, 18-84); most were male (66.4%) and Caucasian (93.5%). 32.9% of pts are confirmed BRAF mutant, 53.6% BRAF wildtype, and 13.5% unknown. When data were available, 21.2% had an elevated lactate dehydrogenase (>ULN), 18.0% had brain metastases, and 23.3% had an ECOG performance status of > 1. At the time of analysis, pts were followed for a median of 12.9 months (mo, range, 0.03 – 39.7). The overall median ToT was 4.4 mo (95% CI, 3.5-5.2), with 4.2, 4.7, 4.2 mo in 1L, 2L, and 3L+, respectively. The overall median OS was 21.9 mo (95% CI, 15.5-29.1), not reached for 1L, and 13.3 and 12.5 mo for 2L and 3L+ respectively. The 1-year and 2-year survival, using the KM method, was 60.9% (95% CI, 56.5-65.0; 1L, 64.9%; 2L, 55.3%; 3L+, 54.6%) and 48.1% (95% CI, 43.2-52.8; 1L, 53.4%; 2L, 41.5%; 3L+, 39.0%) respectively.
The study reports RW use of PEM in a large cohort of pts with AM in US Oncology Clinical Practices. The study pt population is more heterogeneous than that of clinical trials (KEYNOTE-002 and KEYNOTE-006). The findings of ToT and 2-year OS based on RW clinical decision making were consistent with those reported in PEM clinical trials, supporting the RW effectiveness of PEM in pts with AM.
Clinical trial identification
Legal entity responsible for the study
Merck & Co, Inc., Kenilworth, NJ, USA.
Merck & Co., Inc., Kenilworth, NJ, USA.
F.X. Liu, W. Ou, S.J. Diede: Employee, Stock owner: Merck & Co., Inc., Kenilworth, NJ, USA. E.D. Whitman: Consultant, Advisory boards, Speaker’s bureau: Merck, BMS, Genentech, GSK, Novartis, Amgen, Castle Biosciences.