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Safety and tolerability profile of BAVENCIO® (avelumab) in mMCC

Adverse reactions from the JAVELIN Merkel 200 trial (N=88)

  • Serious adverse reactions that occurred in more than one patient were acute kidney injury, anemia, abdominal pain, ileus, asthenia, and cellulitis

  • The most common adverse reactions (≥ 20%) were fatigue (50%), musculoskeletal pain (32%), diarrhea (23%), nausea (22%), infusion-related reaction (22%), rash (22%), decreased appetite (20%), and peripheral edema (20%)

  • 7% (6/88) of patients permanently discontinued treatment due to adverse reactions

    Adverse reactions resulting in permanent discontinuation were ileus, Grade 3 transaminitis, Grade 3 creatine kinase elevation, tubulointerstitial nephritis, and Grade 3 pericardial effusion

  • 24% (21/88) of patients temporarily discontinued treatment due to adverse events

    The most common adverse event requiring dose interruption was anemia*

Excluding temporary dose interruption for infusion-related reactions where infusion was restarted the same day.

The median duration of exposure to BAVENCIO was 4 months (range: 2 weeks to 21 months). 40% of patients received BAVENCIO for more than 6 months and 14% were treated for more than one year