Format

Send to

Choose Destination
J Immunother Cancer. 2018 Jan 19;6(1):7. doi: 10.1186/s40425-017-0310-x.

Updated efficacy of avelumab in patients with previously treated metastatic Merkel cell carcinoma after ≥1 year of follow-up: JAVELIN Merkel 200, a phase 2 clinical trial.

Author information

1
Rutgers Cancer Institute of New Jersey, 195 Little Albany Street, Room 2007, New Brunswick, NJ, 08901, USA. hk553@cinj.rutgers.edu.
2
Present Address: Replimune Inc, Woburn, MA, USA. hk553@cinj.rutgers.edu.
3
H. Lee Moffitt Cancer Center, Tampa, FL, USA.
4
Present Address: Immunocore, Ltd, Conshohocken, PA, USA.
5
The Angeles Clinic and Research Institute, Los Angeles, CA, USA.
6
University of Washington Medical Center, Seattle, WA, USA.
7
University of Lübeck, Lübeck, Germany.
8
Memorial Sloan Kettering Cancer Center & Weill Cornell Medical College, New York, NY, USA.
9
Sarah Cannon Research Institute/Tennessee Oncology, Nashville, TN, USA.
10
APHP Dermatology and CIC Departments, University Paris Diderot INSERM U976, Saint Louis Hospital, Paris, France.
11
Regina Elena National Cancer Institute, Rome, Italy.
12
National Cancer Institute, Bethesda, MD, USA.
13
University of Colorado Denver, School of Medicine, Aurora, CO, USA.
14
Dana-Farber Cancer Institute, Boston, MA, USA.
15
Merck KGaA, Darmstadt, Germany.
16
EMD Serono, Inc, Billerica, MA, USA.
17
University of Washington Medical Center at South Lake Union, Seattle, WA, USA.

Abstract

BACKGROUND:

Merkel cell carcinoma (MCC) is a rare, aggressive skin cancer associated with poor survival outcomes in patients with distant metastatic disease (mMCC). In an initial analysis from JAVELIN Merkel 200, a phase 2, prospective, open-label, single-arm trial in mMCC, avelumab-a human anti-programmed death-ligand 1 (PD-L1) monoclonal antibody-showed promising efficacy and a safety profile that was generally manageable and tolerable. Here, we report the efficacy of avelumab after ≥1 year of follow-up in patients with distant mMCC that had progressed following prior chemotherapy for metastatic disease.

PATIENTS AND METHODS:

Patients received avelumab 10 mg/kg by 1-h intravenous infusion every 2 weeks until confirmed disease progression, unacceptable toxicity, or withdrawal. The primary endpoint was best overall response. Secondary endpoints included duration of response (DOR), progression-free survival (PFS), and overall survival (OS).

RESULTS:

Patients (N = 88) were followed for a minimum of 12 months. The confirmed objective response rate was 33.0% (95% CI, 23.3%-43.8%; complete response: 11.4%). An estimated 74% of responses lasted ≥1 year, and 72.4% of responses were ongoing at data cutoff. Responses were durable, with the median DOR not yet reached (95% CI, 18.0 months-not estimable), and PFS was prolonged; 1-year PFS and OS rates were 30% (95% CI, 21%-41%) and 52% (95% CI, 41%-62%), respectively. Median OS was 12.9 months (95% CI, 7.5-not estimable). Subgroup analyses suggested a higher probability of response in patients receiving fewer prior lines of systemic therapy, with a lower baseline disease burden, and with PD-L1-positive tumors; however, durable responses occurred irrespective of baseline factors, including tumor Merkel cell polyomavirus status.

CONCLUSIONS:

With longer follow-up, avelumab continues to show durable responses and promising survival outcomes in patients with distant mMCC whose disease had progressed after chemotherapy.

TRIAL REGISTRATION:

Clinicaltrials.gov identifier: NCT02155647.

KEYWORDS:

Avelumab; Javelin; Merkel cell carcinoma; Pd-L1

Supplemental Content

Full text links

Icon for BioMed Central Icon for PubMed Central
Loading ...
Support Center