Brentuximab Vedotin + RCHP Active in High-intermediate/High Risk DLBCL
Brentuximab vedotin in combination with RCHP (rituximab, cyclophosphamide, doxorubicin, and prednisone) is active as a frontline therapy.
SAN DIEGO – In patients with CD30-expressing, high-intermediate/high risk diffuse large B-cell lymphoma (DLBCL), brentuximab vedotin in combination with RCHP (rituximab, cyclophosphamide, doxorubicin, and prednisone) is active as a frontline therapy, according to a study presented at the American Society of Hematology (ASH) 58th Annual Meeting and Exposition.1
"Patients with high-risk, newly diagnosed DLBCL often experience disease resistance or relapse," said Lihua E. Budde, MD, PhD, of the City of Hope National Medical Center in Duarte, California. "Brentuximab vedotin has demonstrated encouraging single-agent activity in patients with relapsed or refractory DLCBL."
Researchers designed a phase 2 trial (ClinicalTrials.gov Identifier: NCT01925612) to evaluate the safety and efficacy of frontline brentuximab vedotin plus RCHP or RCHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, prednisone).
In part 1 of the ongoing study, researchers enrolled 51 patients with high-intermediate or high risk DLBCL to receive brentuximab vedotin 1.2 or 1.8 mg/kg plus CHOP. In part 2, investigators enrolled 11 patients with CD-30 expressing high-intermediate or high risk DLBCL to receive brentuximab vedotin 1.8 mg/kg plus RCHP.
Results of part 1 showed that the estimated 24-month progression-free survival for patients with CD30 expression was 79% (95% CI, 57-91) compared with 52% (95% CI, 30-70) among patients without detectable CD30 expression; 24-month overall survival was 92% (95% CI, 71-98) vs 67% (95% CI, 44-82), respectively.
"The progression-free survival and overall survival for patients with CD30-expressing DLBCL who received brentuximab vedotin plus RCHOP appear encouraging," said Dr Budde.
Researchers found that 73% of the 51 patients who received brentuximab vedotin plus RCHOP experienced treatment-emergent peripheral neuropathy. Of those, 43% had resolution of all or some neurotoxic events.
Part 2 showed that the overall response rate of patients treated with brentuximab vedotin combined with RCHP was 91%, including 9 complete remissions and 1 partial remission. Eight patients experienced grade 3 to 4 adverse events and 5 patients had non-fatal serious adverse events. Peripheral sensory neuropathy occurred in 6 patients and all were of grade 1 to 2 severity. There were no reported cases of peripheral motor neuropathy.
"When combined with RCHP, 1.8 mg/kg brentuximab vedotin appears to be more tolerable than the combination with RCHOP," noted Dr Budde.
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"The majority of patients with CD30-expressing, high-intermediate or high-risk DLBCL treated with brentuximab vedotin plus RCHP experienced disease response without unacceptable side effects. These results support further evaluation of the combination of brentuximab vedotin with frontline therapy for lymphoma."
- Budde LE, Halwani A, Yasenchak CA, et al. Results of an ongoing phase 2 study of brentuximab vedotin with RCHP as frontline therapy in patients with high-intermediate/high-risk diffuse large B-cell lymphoma (DLBCL). Paper presented at: American Society of Hematology (ASH) 58th Annual Meeting and Exposition; December 3-6, 2016; San Diego, CA.