BAVENCIO® (avelumab) JAVELIN Merkel 200 Trial Efficacy

OVERALL RESPONSE RATE (ORR)

JAVELIN Merkel 200: the largest trial of immunotherapy in metastatic MCC (N=204)

In the Phase 2, open-label, single-arm, multicenter study of 204 patients with mMCC:

MORE THAN ONE-THIRD OF PATIENTS HAD AN OVERALL RESPONSE

1L (cohort B): patients with mMCC who were treatment-naive

(N=116)

40% ORR*

(95% CI: 31, 49) (n=46/116)

  • Complete response – 16% (n=19/116)
  • Partial response – 23% (n=27/116)

2L+ (cohort A): patients with mMCC whose disease progressed on

or after chemotherapy for distant metastatic disease

(N=88)

33% ORR*

(95% CI: 23, 44) (n=29/88)

  • Complete response – 11% (n=10/88)
  • Partial response – 22% (n=19/88)

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

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

DURATION OF RESPONSE

1L (COHORT B): PATIENTS WITH METASTATIC MCC WHO WERE TREATMENT-NAIVE

Median duration of response was 18.2 months (range: 1.2+ to 28.3+ months)

Responses lasting ≥6 months

76%

(n=35/46)

Responses lasting ≥1 year

52%

(n=24/46)

2L+ (COHORT A): PATIENTS WITH METASTATIC MCC WHOSE DISEASE PROGRESSED ON OR AFTER CHEMOTHERAPY FOR DISTANT METASTATIC DISEASE

Median duration of response was 40.5 months (range: 2.8 to 41.5+ months)

Responses lasting ≥6 months

90%

(n=26/29)

Responses lasting ≥1 year

66%

(n=19/29)

Reference: Bavencio. Prescribing information. EMD Serono, Inc; 2023.