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Malignancies in Clinical Trials

ASCLEPIOS controlled period^1,a

• Five patients (0.5%) in the ofatumumab group reported malignant events compared to four patients in the teriflunomide group (0.4%)
• Of the five patients in the ofatumumab group:
  • Invasive breast carcinoma was reported within 5 months of treatment initiation
  • Malignant melanoma in situ was reported within 39 days
  • Non-Hodgkin's lymphoma (recurrent) was diagnosed within 31 days
  • The two cases of basal cell carcinoma were confounded and assessed by the investigator as not related to ofatumumab therapy
• The four cases of basal cell carcinoma (two in each treatment group) resolved after surgery, and patients were allowed to remain on study treatment after full excision of basal cell carcinoma

Open-label extension period^2,b

• No new cases of malignancies were observed

^aIncludes data of patients pooled from the ASCLEPIOS I and ASCLEPIOS II trials during the controlled treatment period.

^bOpen-label extension includes cumulative data of all patients (N=1873) who were randomized to ofatumumab 20 mg in ASCLEPIOS I, ASCLEPIOS II, APLIOS studies, completed the core period of the study, and continued to be treated with ofatumumab 20 mg in open-label ALITHIOS or either completed or discontinued the core period of the study and continued with safety follow-up epoch of the core study and newly switched group (who were randomized to teriflunomide 14 mg in ASCLEPIOS I and ASCLEPIOS II, completed the core period of the study, and switched to ofatumumab 20 mg in open-label ALITHIOS).