BAVENCIO® (avelumab) JAVELIN Merkel 200 Trial Efficacy


Avelumab (BAVENCIO)

RECOMMENDED by the National Comprehensive Cancer Network® (NCCN®) as an option for patients with disseminated Merkel cell carcinoma (category 2A)1

The NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way.

BAVENCIO has been prescribed for more than 1750 US mMCC patients3*

*Estimate is based on IQVIA US sales and prescription data from April 2017 to May 2019.


Accelerated approval based on data from JAVELIN Merkel 200–the largest trial of immunotherapy in metastatic MCC (N=88)2

In the Phase 2, open-label, single arm, multicenter study of 88 patients with mMCC whose disease progressed on or after chemotherapy for distant metastatic disease2:


33% ORR*

(95% CI: 23.3, 43.8) (n=29/88)

  • Complete response – 11% (n=10/88) (95% CI: 6.6, 19.9)
  • Partial response – 22% (n=19/88) (95% CI: 3.5, 31.7)

35% (n=31/88)

of patients had received ≥2 lines of previous therapy

Responses were observed regardless of PD-L1 tumor expression or presence of Merkell cell polyomavirus (MCPyV)

*Response criteria were defined according to RECIST v1.1.
CI=confidence interval.


Durable responses extended beyone one year

29 patients experienced a confirmed response, with almost half lasting at least 1 year (range: 2.8 to 23.3+ months)

Responses lasting ≥6 months



Responses lasting ≥1 year



  • 76% (n=22/29) of responses were seen by the first observation3
  • 72% (n=21/29) of responses were ongoing at the time of data cutoff3
  • The median duration of response had not yet been reached at the time of analysis, with a minimum follow-up of 12 months3


Additional response data3

Efficacy Data
Efficacy Data
Efficacy Data
Efficacy Data


In a subsequent, uncensored analysis of the JAVELIN Merkel 200 Trial, responses lasted beyond 2 years (range: 2.8-31.8 months)3*

  • Responses lasting ≥6 months



  • Responses lasting ≥1 year



  • Responses lasting ≥2 years



*These data on durations of response are based on different data with a minimum of 2 years of follow-up in all patients (EMR 100070-003) Part A; cutoff date September 26, 2017). The relative frequencies presented do not account for censoring. 

References: 1. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Merkel Cell Carcinoma V.1.2021. © National Comprehensive Cancer Network, Inc. 2021. All rights reserved. Accessed May 20, 2021. The NCCN Guidelines® and illustrations herein may not be reproduced in any form for any purpose without the express written permission of NCCN. To view the most recent and complete version of the guidelines, go online to NCCN makes no warranties of any kind whatsoever regarding their content or its use or application and disclaims any responsibility for its use or application in any way. 2. Kaufman HL, Russell J, Hamid O, et al. Avelumab in patients with chemotherapy-refractory metastatic Merkel cell carcinoma: a multicentre, single-group, open-label, phase 2 trial. Lancet Oncol. 2016;17(10):1374-1385. 3. Data on file. Rockland, Mass: EMD Serono, Inc.