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Cyclacel Pharmaceuticals, Inc. Message Board

  • mgs1066 mgs1066 Mar 2, 2013 5:43 PM Flag

    Boehringer Ingelheim vs. SAP and dacogen

    Boehringer Ingelheim:

    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).

    SAP/ DAC

    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.

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