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Bendamustine treatment of Chinese patients with relapsed indolent non-Hodgkin lymphoma: a multicenter, open-label,
Yuan-Kai Shi1, Xiao-Nan Hong2, Jian-Liang Yang1
1Department of Medical Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing Key Laboratory of Clinical Study on Anticancer Molecular Targeted Drugs, Beijing 100021, China.
Background:
Bendamustine was approved in China on May 26th, 2019 by the National Medical Product Administration for the treatment of indolent B-cell non-Hodgkin lymphoma (NHL). The current study was the registration trial and the first reported evaluation of the efficacy, safety, and pharmacokinetics of bendamustine in Chinese adult patients with indolent B-cell NHL following relapse after chemotherapy and rituximab treatment.
Methods:
This was a prospective, multicenter, open-label, single-arm, phase 3 study (NCT01596621; C18083/3076) with a 2-year follow-up period. Eligible patients received bendamustine hydrochloride 120 mg/m2 infused intravenously on days 1 and 2 of each 21-day treatment cycle for at least six planned cycles (and up to eight cycles). The primary endpoint was the overall response rate (ORR); and secondary endpoints were duration of response (DoR), progression-free survival (PFS), safety, and pharmacokinetics. Patients were classified according to their best overall response after initiation of therapy. Proportions of patients in each response category (complete response [CR], partial response [PR], stable disease, or progressive disease) were summarized along with a two-sided binomial exact 95% confidence intervals (CIs) for the ORR.
Results:
A total of 102 patients were enrolled from 20 centers between August 6th, 2012, and June 18th, 2015. At the time of the primary analysis, the ORR was 73% (95% CI: 63%-81%) per Independent Review Committee (IRC) including 19% CR and 54% PR. With the follow-up period, the median DoR was 16.2 months by IRC and 13.4 months by investigator assessment; the median PFS was 18.6 months and 15.3 months, respectively. The most common non-hematologic adverse events (AEs) were gastrointestinal toxicity, pyrexia, and rash. Grade 3/4 neutropenia was reported in 76% of patients. Serious AEs were reported in 29 patients and five patients died during the study. Pharmacokinetic analysis indicated that the characteristics of bendamustine and its metabolites M3 and M4 were generally consistent with those reported for other ethnicities.
Conclusion:
Bendamustine is an active and effective therapy in Chinese patients with relapsed, indolent B-cell NHL, with a comparable risk/benefit relationship to that reported in North American patients.
Clinical Trial Registration:
ClinicalTrials.gov, No. NCT01596621; https://clinicaltrials.gov/ct2/show/NCT01596621.
Insights
Bendamustine demonstrates efficacy in Chinese patients with relapsed indolent B-cell non-Hodgkin lymphoma (NHL). The study confirms a favorable risk/benefit profile comparable to other populations.
Area of Science:
- Oncology
- Hematology
- Clinical Pharmacology
Background:
- Bendamustine's approval in China for indolent B-cell non-Hodgkin lymphoma (NHL) on May 26th, 2019.
- This registration trial evaluated bendamustine in Chinese adult patients with relapsed indolent B-cell NHL after prior chemotherapy and rituximab treatment.
Purpose of the Study:
- To assess the efficacy, safety, and pharmacokinetics of bendamustine in Chinese patients with relapsed indolent B-cell NHL.
- To establish bendamustine as an active and effective therapy in this specific patient population.
Main Methods:
- Prospective, multicenter, open-label, single-arm, phase 3 study (NCT01596621) with 2-year follow-up.
- Bendamustine hydrochloride 120 mg/m2 administered intravenously on days 1 and 2 of each 21-day cycle for 6-8 cycles.
- Primary endpoint: Overall Response Rate (ORR); Secondary endpoints: Duration of Response (DoR), Progression-Free Survival (PFS), safety, and pharmacokinetics.
Main Results:
- Overall Response Rate (ORR) was 73% (19% Complete Response, 54% Partial Response) per Independent Review Committee (IRC).
- Median Duration of Response (DoR) was 16.2 months (IRC), and median Progression-Free Survival (PFS) was 18.6 months (IRC).
- Common adverse events included gastrointestinal toxicity, pyrexia, and rash; Grade 3/4 neutropenia occurred in 76% of patients. Pharmacokinetics were consistent with other ethnicities.
Conclusions:
- Bendamustine is an active and effective treatment for Chinese patients with relapsed indolent B-cell NHL.
- The risk/benefit profile in this population is comparable to that observed in North American patients.
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