In a Phase II study reported last year, volasertib plus LDAC achieved an objective response in 31% of patients, significantly better than the 13% response rate seen with LDAC alone. Event-free survival (EFS) was also better with combination therapy at 5.6 months versus 2.3 months (The Pharma Letter December 12, 2012).
Cyclacel Presents Updated Survival Data From the Pilot Study and Lead-In Phase of Seamless Phase 3 Study at the 2012 ASH Annual Meeting
Median Overall Survival is 238 days, or Approximately 8 Months, and 1-Year Survival is 35% With an Overall Response Rate of 41% in Elderly Patients With Newly Diagnosed AML
Forty-six patients were treated with alternating cycles of sapacitabine and decitabine, which is the treatment regimen in the experimental arm of SEAMLESS. Median age is 77 years (range 70-90). Thirty-three patients (72%) are 75 years or older. Median overall survival is 238 days, or approximately 8 months. The number of patients still alive at 3 months was 38 (83%), at 6 months 30 (65%), at 12 months 16 (35%) and at 18 months 12 (26%). Sixteen patients (35%) survived 1 year or longer. Among 33 patients who are 75 years or older, median overall survival is 263 days, or approximately 9 months, and 1-year survival is 36%. Nineteen patients (41%) responded with 10 complete responses (CRs), 4 partial responses (PRs) and 5 major hematological improvements (HIs). Median time to response is 2 cycles, i.e., one cycle of decitabine and one cycle of sapacitabine (range 1-10). Twenty-seven patients (59%) received 5 or more cycles of treatment. Two dose-limiting toxicities (DLT) were observed (lung infection/sepsis, typhlitis). Thirty-day mortality from all causes was 4%. Sixty-day mortality from all causes was 13% with one death from typhlitis considered to be possibly related to decitabine by investigator assessment. The sequential combination of decitabine and sapacitabine is safe and active.