Biotech Values

[DewDiligence]

ABBV/JNJ—Striking Imbruvica results in first-line CLL (for patients ≤70 yrs):

https://ash.confex.com/ash/2018/webprogram/Paper120779.html

Eligible patients were treatment-naive individuals with CLL who were age ≤70 and required therapy. Patients with deletion 17p- were excluded from participating given the poor response of these patients to FCR therapy. Participants were randomly assigned in a 2:1 ratio to receive ibrutinib (420 mg/day until disease progression) and rituximab (50 mg/m2 on day 1 of cycle 2; 325 mg/m2 on day 2 of cycle 2; 500 mg/m2 on day 1 of cycles 3-7) or six courses of intravenous fludarabine (25 mg/m2 ) and cyclophosphamide (250 mg/m2) days 1-3 with rituximab (50 mg/m2 on day 1 of cycle 1; 325 mg/m2 on day 2 of cycle 1; 500 mg/m2 on day 1 of cycles 2-6) every 28-days.

… The first interim analysis was performed September 2018. With median follow-up of 33.4 months, we observed 77 PFS events and 14 deaths. The hazard ratio (HR) for PFS favored IR over FCR (HR=0.352; 95% CI 0.223-0.558; p<0.0001) which crossed the pre specified boundary.

The HR for OS also favored the IR arm (HR=0.168 [!], 95% CI 0.053-0.538; p=0.0003, pre-specified boundary for superiority p=0.0005).