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Published on: September 25, 2018
Phase 2 randomized study of p53 antisense oligonucleotide (cenersen) plus idarubicin with or without cytarabine in
Jorge Cortes1, Hagop Kantarjian, Edward D Ball
1Department of Leukemia, University of Texas MD Anderson Cancer Center, 1515 Holcombe Boulevard, Unit 428, Houston, TX 77030, USA. jcortes@mdanderson.org
Background:
The p53 antisense oligonucleotide cenersen has been shown to sensitize acute myeloid leukemia (AML) stem cells to DNA damaging agents.
Methods:
To determine whether cenersen merits testing in larger efficacy studies, an exploratory study of cenersen in combination with idarubicin either alone or with 1 of 2 doses of cytarabine was performed in first-salvage AML patients. Patients who either had failed to respond to a single induction course or had responded to induction but relapsed within 12 months were enrolled. Stopping rules based on an expected 14% complete response (CR) rate were applied to each treatment arm.
Results:
Fifty-three patients were treated, and none of the arms was terminated for lack of activity. Nearly all patients received a single course unless they responded. Ten of the 53 (19%) patients responded (8 CR and 2 CR with incomplete platelet recovery). There was a positive trend for a better response rate with increasing intensity of chemotherapy in the patients refractory to front-line treatment compared with those who had relapsed previously. One-third (17/53) of the patients received cenersen inhibitors (acetaminophen and/or high dose antioxidants) during treatment, and none of these responded to treatment. No unique toxicity was attributed to cenersen.
Conclusion:
The results of this study suggested that the combination of cenersen with chemotherapy may have clinical efficacy, and additional studies are warranted to explore its full potential.
Insights
Cenersen, an antisense oligonucleotide, showed potential in treating acute myeloid leukemia (AML) stem cells when combined with chemotherapy. Further studies are recommended to explore its efficacy in AML patients.
Area of Science:
- Hematology
- Oncology
- Pharmacology
Background:
- Cenersen, a p53 antisense oligonucleotide, enhances the sensitivity of acute myeloid leukemia (AML) stem cells to DNA-damaging agents.
- This study investigated the potential of cenersen in combination therapy for AML.
Purpose of the Study:
- To evaluate the efficacy of cenersen combined with idarubicin and cytarabine in first-salvage AML patients.
- To determine if cenersen warrants further investigation in larger clinical trials.
Main Methods:
- An exploratory study involving 53 first-salvage AML patients treated with cenersen and idarubicin, with or without cytarabine.
- Patients were categorized based on prior treatment response (refractory or relapsed).
- Stopping rules were based on a 14% complete response (CR) rate target.
Main Results:
- None of the treatment arms were stopped due to lack of activity.
- A 19% overall response rate (10/53 patients) was observed, including 8 complete responses.
- Patients refractory to front-line treatment showed a trend towards better response with increased chemotherapy intensity.
- No unique toxicity was associated with cenersen; however, patients receiving cenersen inhibitors did not respond.
Conclusions:
- The combination of cenersen with chemotherapy suggests potential clinical efficacy in AML.
- Further research is necessary to fully understand and exploit the therapeutic potential of cenersen in AML treatment.
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