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Abstract
Objective:
This meta-analysis evaluated the antitumor activity of brentuximab vedotin versus historical values in patients with relapsed/refractory Hodgkin lymphoma post-autologous stem cell transplantation (ASCT).
Methods:
A systematic literature review identified studies (1993–February 2013) reporting complete remission (CR) rates in patients with relapsed/refractory Hodgkin lymphoma post-ASCT. Publications reporting CR rates, identified through interrogation of multiple electronic databases and manual searches (with search terms used to capture ‘relapsed’, ‘refractory’, ‘HL’, and ‘ASCT’), were included if they reported: ≥20 relapsed/refractory Hodgkin lymphoma patients, where ≥80% were aged ≥12 years and ≥50% had failed prior ASCT. Overall CR rate was determined using a random-effect model, and compared with that reported for brentuximab vedotin in a pivotal phase 2 trial (SG035-0003).
Main outcome measures:
Across 17 evaluable studies of historical or experimental agents (n = 812), the estimated overall CR rate was 11.1% (95% confidence interval [CI] 7.0, 17.6; range, 0–38.5%) versus 33.3% (95% CI 25.3, 43.9) for brentuximab vedotin (p < 0.0001). In sensitivity analyses, the estimated overall CR rates for historical/experimental agents were 13.6% (95% CI 8.7, 21.4) when only HL trials that reported a CR rate of >0% were included (13 studies; n = 696; p = 0.0009 vs. brentuximab vedotin), and 9.0% (95% CI 4.9, 16.6) when only HL trials were included where CR definition was reported and was measured using the same criteria as in the SG035-0003 study (12 studies; n = 562; p = 0.0001 vs. brentuximab vedotin).
Conclusions:
Indirect comparisons against a heterogeneous historical sample population naturally limit our ability to draw comparisons, yet the results from this quantitative meta-analysis suggest that the antitumor activity of brentuximab vedotin may exceed that of other therapies used to treat patients with relapsed/refractory Hodgkin lymphoma post-ASCT.
Transparency
Declaration of funding
The analysis was funded by Millennium: The Takeda Oncology Company. Employees at Millennium: The Takeda Oncology Company were involved in the design, data collection and analysis of this study, as well as writing of the final report.
V.B., E.W., H.Y., Y.L., A.C., and D.H. designed the research. V.B., E.W., H.Y., Y.L., and A.C. performed the research. V.B. contributed vital new reagents or analytical tools. V.B., A.M., H.Y., O.S., Y.L., and D.H. analyzed the data. V.B. and H.Y. wrote the paper.
Declaration of financial/other relationships
V.B. and O.S. have disclosed that they are employed by Millennium: The Takeda Oncology Company. D.H., A.C., and Y.L. have disclosed that they are employed by Takeda Pharmaceuticals International Co. V.B., O.S., Y.L., A.C., and D.H. have disclosed that they have ownership interest in a publicly traded company (Takeda). E.W., A.M., and H.Y. have disclosed that they received honoraria directly from Millennium: The Takeda Oncology Company, a consulting fee received by the Analysis Group Inc., of which E.W., A.M., and H.Y. are employees, to partner this research.
CMRO peer reviewers on this manuscript have received an honorarium from CMRO for their review work, but have no other relevant financial relationships to disclose.
Acknowledgments
The authors would like to acknowledge the statistical support of Donghui Yang of Takeda Pharmaceuticals International Co., and the writing assistance of Steve Hill and Tamara Bailey of FireKite, an Ashfield business, part of UDG Healthcare plc, during the development of this publication, which was funded by Millennium: The Takeda Oncology Company.
Previous presentation: Presented in abstract form at the 9th International Symposium on Hodgkin Lymphoma, Cologne, Germany, 12–15 October 2013.