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Malignancies in Clinical Trials

Controlled period^1,a

• Five patients (0.5%) in the ofatumumab group reported malignant events compared to four patients in teriflunomide group (0.4%)
• Of the 5 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

OMB overall pool^2,b

• As of 25-Sep-2022, EAIRs for malignancies did not increase over time in the overall ofatumumab population 
  for up to 5 years
• Cumulatively (core+extension), malignancies were reported in 21 patients^c (1.07%) with EAIR of 0.32 (95% CI: 0.21, 0.48)
• Median onset time since the first dose of ofatumumab was 565 days (range:191—1747 days)

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

^bincludes cumulative data of all patients (N=1969) who were randomized to ofatumumab 20 mg in ASCLEPIOS I, ASCLEPIOS II, APLIOS and APOLITOS 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).

^c21 malignancies includes breast and nipple neoplasms malignant (n=9); colorectal neoplasms malignant (n=1); metastases to specified sites (n=1); esophageal neoplasms malignant (n=1); neoplasms malignant site unspecified NEC (n=1); non-Hodgkin's lymphomas NEC (n=1); ovarian neoplasms malignant (excl germ cell) (n=1); renal neoplasms malignant (n=2); skin melanomas (excl ocular) (n=1); skin neoplasms malignant and unspecified (excl melanoma) (n=4).