ere Asian and 4% were Hispanic. Thirty-six (47%) patients had failed treatment with imatinib, dasatinib, and nilotinib. Most patients had also received prior non-TKI treatments, most commonly hydroxyurea (54%), interferon (30%), and/or cytarabine (29%).
The efficacy endpoint was based on MCyR (adjudicated by a DMC).
Table 4: Efficacy Results eva luated by DMC for Patients with CP CML
Patients
(N=76)
Primary Response – MCyR
Total with MCyR, n (%)
14 (18.4)
95% confidence interval
(10.5% – 29.0%)
Cytogenetic Response, n (%)
Confirmed complete
6 (7.9)
Confirmed partial
3 (3.9)
Cytogenetic response eva luation is based on standard cytogenetic analysis (at least 20 metaphases).
Complete: 0% Ph+ cells, Partial > 0% to 35% Ph+ cells
The mean time to MCyR onset in the 14 patients was 3.5 months. The median duration of MCyR for the 14 patients was 12.5 months (Kaplan-Meier estimate).
14.2 Accelerated Phase CML (AP CML)
A total of 35 patients with accelerated phase CML were included in the efficacy analysis. The demographics were: median age was 63 years, 57% were male, 46% were 65 years of age or older, 68% were Caucasian, 23% were African-American, 3% were Asian and 3% were Hispanic. Twenty-two (63%) of 35 patients with accelerated phase had failed treatment with imatinib, dasatinib, and nilotinib. Most patients had also received prior non-TKI treatments, most commonly hydroxyurea (43%), interferon (31%), and/or cytarabine (29%). The efficacy endpoint was assessed based on MCyR and MaHR (complete hematologic response [CHR] or no evidence of leukemia [NEL]). The efficacy results for the patients with accelerated phase as adjudicated by the DMC are shown in Table 5.
Table 5: Efficacy Results eva luated by DMC for Patients with AP CML
Accelerated Phase (N=35)
Primary Response - MaHR
Total with MaHR, n (%)
5 (14.3)
95% lower confidence interval
(4.5% - 30.3%)
CHR
4 (11.4)
NEL
1 (2.9)
Primary Response - MCyR
Total with MCyR, n (%)
0
MaHR is defined as complete hematologic response (CHR) or no evidence of leukemia (NEL): CHR - absolute neutrophil count ≥ 1.5 × 109/liter, platelets ≥ 100 × 109/liter, no blood blasts, bone marrow blasts < 5%, no extramedullary disease; NEL - Morphologic leukemia-free state, defined as <5% bone marrow blasts.
The mean time to response onset in the 5 patients was 2.3 months. The median duration of MaHR for the 5 patients was 4.7 months (Kaplan-Meier estimate).
15 REFERENCES
1.OSHA Hazardous Drugs. OSHA. http://www.osha.gov/SLTC/hazardousdrugs/index.html.
16 HOW SUPPLIED/STORAGE AND HANDLING
16.1 How Supplied
SYNRIBO (omacetaxine mepesuccinate) for Injection is supplied in 8 mL clear glass single-use vial in individual cartons. Each vial contains 3.5 mg of SYNRIBO (omacetaxine mepesuccinate) for Injection (NDC 63459-177-14).
16.2 Storage and Handling
Store at 20oC to 25ºC (68o C to 77ºF); excursions permitted from 15ºC to 30ºC (59ºF to 86ºF). Until use, keep product in carton to protect from light.
Omacetaxine mepesuccinate is an antineoplastic product. Follow special handling and disposal procedures1.
17 PATIENT COUNSELING INFORMATION
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