BAVENCIO® (avelumab) Clinical Trial

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

One-third of patients treated with BAVENCIO® (avelumab) had an overall response

MAJOR EFFICACY OUTCOME MEASURE

33%

(95% Cl, 23.3-43.8) (N=88)

overall
response rate

in a population that

included heavily

pretreated patients

Overall responses

  • 11% (n=10/88) Complete response* (CR) (95% CI, 6.6-19.9)1
  • 22% (n=19/88) Partial Response* (PR) (95% CI, 13.5-31.7)1
Response criteria were defined according to RECIST v1.1. CR was defined as disappearance of all target lesions. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.2

 

MAJOR EFFICACY OUTCOME MEASURE
Among patients with confirmed response (n=29)

BAVENCIO demonstrated durable responses that extended beyond 1 year

86%

(n=25/29)
of responses

lasted for at least 6 months

(range, 2.8 to
23.3+ months)

45%

(n=13/29)
of responses

lasted for at least 1 year

(range, 2.8 to
23.3+ months)

References: 1. Data on file. Rockland, Mass: EMD Serono, Inc; 2017. 2. Eisenhauer EA, Therasse P, Bogaerts J, et al. New response evaluation criteria in solid tumors: revised RECIST guideline (version 1.1). Eur J Cancer. 2009;45(2):228-247.

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

45% (n=13/29) of responses to BAVENCIO® (avelumab) lasted for at least 1 year

29 of 88 patients had a complete or partial response1

Tumor response assessments were performed every 6 weeks

Reference: 1. Data on file. Rockland, Mass: EMD Serono, Inc; 2017.

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