ESMO Supporter 2018

Found 1 Presentation For Request ""Real-world experience of pembrolizumab in patients with advanced melanoma: A large retrospective observational study""

Poster display session: Biomarkers, Gynaecological cancers, Haematological malignancies, Immunotherapy of cancer, New diagnostic tools, NSCLC - early stage, locally advanced & metastatic, SCLC, Thoracic malignancies, Translational research Poster Display session

1220P - Real-World Experience of Pembrolizumab in Patients with Advanced Melanoma: A Large Retrospective Observational Study

Presentation Number
1220P
Lecture Time
12:30 - 12:30
Speakers
  • Frank Xiaoqing Liu (North Wales, US)
Location
Hall A3 - Poster Area Networking Hub, ICM M√ľnchen, Munich, Germany
Date
20.10.2018
Time
12:30 - 13:30

Abstract

Background

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.

Methods

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.

Results

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.

Conclusions

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.

Legal entity responsible for the study

Merck & Co, Inc., Kenilworth, NJ, USA.

Funding

Merck & Co., Inc., Kenilworth, NJ, USA.

Editorial Acknowledgement

Not applicable

Disclosure

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.

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