DACOGEN Phase III Trials Clinical Responses

DACOGEN^®(decitabine) for injection is approved for the treatment of myelodysplastic syndromes (MDS) of previously treated and untreated MDS, de novo and secondary MDS, all French-American-British (FAB) subtypes (RA, RARS, RAEB, RAEB-t, CMML), Intermediate-1, Intermediate-2, and High-risk International Prognostic Scoring System (IPSS) groups³ based on the outcomes of a randomized, controlled phase III trial of 170 patients with MDS.^1,2

DACOGEN response rates were superior to supportive care response rates Figure 1¹

Figure 1. Overall Response Rates^1,2

6 patients never received therapy; 19 patients received 1 course of therapy; 18 patients received 2 courses of therapy

* p<0.001 for pairwise difference (from two-sided Fisher's exact test) between DACOGEN + supportive care vs supportive care alone. No complete or partial responses were achieved with supportive care.
^† A randomized, open-label, controlled trial. Patients in the DACOGEN arm received an intravenous infusion of 15 mg/m² over 3 hours, every 8 hours, for 3 days. Supportive care consisted of blood transfusions, prophylactic antibiotics, and hematopoietic growth factors.
^‡ Patients received a median of 3 cycles of treatment.

Response Rates

• 21% response rate (CR or PR) in participants with pathologically confirmed MDS who received at least 2 cycles of treatment (n=56).¹
• Durable responses, with a median duration of 41 weeks.
• Median time to acute myelogenous leukemia or death of 49 weeks vs 31 weeks with supportive care (p = 0.160 [not significant]).¹²

Cytogenetic Response

In a subset of participants (n=26) in the DACOGEN arm of the randomized, controlled, phase III trial were evaluated for cytogenetic responses.

These responses included del(5q), +8, del(7), del(20q), del(10q), and complex abnormalities.^2,3 Responses are summarized in Figure 2.

38% (10/26) achieved a cytogenetic response when treated with DACOGEN.

• All clinical responders who were evaluable for cytogenetic response were also cytogenetic responders

Figure 2. Cytogenetic Responses^2,3

^† 9 major responses (no detectable cytogenetic abnormality on follow-up), 1 minor response (>50% reduction in abnormal metaphases).

Implications of cytogenetic abnormalities include the following:

• Other than isolated del(5q), del(20q) or –Y, the International Prognostic Scoring System has found all cytogenetic abnormalities to have a negative impact on patient prognosis.
• Patients with complex karyotypes (i.e., ≥ 3 anomalies) or isolated -7 or del(7q) abnormalities are considered poor risk and have a median survival of 0.8 years.⁷
• Clinical significance of these findings has not been fully established.

For more details about DACOGEN clinical trials, watch our DACOGEN Clinical Trials Video.

References

IMPORTANT SAFETY INFORMATION

DACOGEN may cause fetal harm when administered to a pregnant woman. Women of childbearing potential should be advised to avoid becoming pregnant while using DACOGEN. Men should be advised not to father a child while receiving treatment with DACOGEN, and for 2 months afterwards. The most commonly occurring adverse reactions include neutropenia, thrombocytopenia, anemia, pyrexia, fatigue, nausea, cough, petechiae, constipation, diarrhea, and hyperglycemia.

DACOGEN is available by prescription only. Please see the important product information for DACOGEN for more information. This site does not contain everything that is known about DACOGEN. If you would like to know more, talk to your healthcare professional.

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