Arzerra ofatumumab: Phase III data
Top-line data from an international Phase III trial in 116 rituximab-refractory patients showed that 1,000 mg Arzerra (n=86) led to an overall response rate (ORR) of 10%, including 1 complete response and 8 partial responses, plus 43 cases of stable disease at 6 months. The median durations of survival and progression-free survival (PFS) were each 6 months in the 1,000 mg Arzerra arm. ORR was 11% in the total population, 22% in patients refractory to rituximab monotherapy, 7% in patients refractory to rituximab in combination with chemotherapy, and 9% in patients refractory to rituximab maintenance. The most common adverse events were rash, urticaria, pruritus, fatigue, nausea, pyrexia and cough. Patients received 1 infusion of 300 mg Arzerra followed by 7 weekly infusions of 1,000 or 500 mg (n=30) Arzerra.
In 2007, the trial was amended to drop the 500 mg dose (see BioCentury, Oct. 1, 2007). Genmab spokesperson Helle Husted told BioCentury, "The results did not reach the level that would trigger a milestone payment pursuant to its agreement" with GlaxoSmithKline, which has exclusive rights to co-develop and commercialize the compound under a 2006 deal with Genmab (see BioCentury, Jan. 1, 2007). Last December, Genmab declined to exercise its option to co-promote Arzerra (see BioCentury, Jan. 5). ...