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Role of brentuximab vedotin in the treatment of relapsed or refractory Hodgkin lymphoma.

ABSTRACT: Brentuximab vedotin (BV) is an antibody-drug conjugate that targets CD30-positive malignancies via an anti-CD30 monoclonal antibody linked to monomethyl auristatin E, a microtubule-disrupting agent, by a protease-cleavable linker. BV has received accelerated approval from the US Food and Drug Administration for the treatment of classical Hodgkin lymphoma that has relapsed either after autologous stem cell transplantation (ASCT) or after two lines of combination chemotherapy in patients ineligible for ASCT, and in systemic anaplastic large cell lymphoma after failure of at least one line of multiagent chemotherapy. Phase I studies in CD30-positive lymphomas have determined the maximum tolerated dose to be 1.8 mg/kg intravenously every 21 days. In relapsed/refractory Hodgkin lymphoma, a pivotal Phase II study of single-agent BV showed an overall response rate of 75%, with 34% complete responses and a median remission duration of 20 months for complete responders. BV has a modest toxicity profile, with peripheral neuropathy as one of the most clinically significant side effects, and this is largely reversible. Therefore, BV is the treatment of choice for patients with relapsed/refractory Hodgkin lymphoma after ASCT or two standard regimens. Ongoing trials are evaluating the role of BV as salvage therapy prior to ASCT and for maintenance after ASCT for patients with relapsed/refractory disease.

SUBMITTER: Siddiqi T

PROVIDER: S-EPMC3959807 | biostudies-literature | 2014

REPOSITORIES: biostudies-literature

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Role of brentuximab vedotin in the treatment of relapsed or refractory Hodgkin lymphoma.

Siddiqi Tanya T Thomas Sandra H SH Chen Robert R

Pharmacogenomics and personalized medicine 20140220

Brentuximab vedotin (BV) is an antibody-drug conjugate that targets CD30-positive malignancies via an anti-CD30 monoclonal antibody linked to monomethyl auristatin E, a microtubule-disrupting agent, by a protease-cleavable linker. BV has received accelerated approval from the US Food and Drug Administration for the treatment of classical Hodgkin lymphoma that has relapsed either after autologous stem cell transplantation (ASCT) or after two lines of combination chemotherapy in patients ineligibl ...[more]

PMID: 24672256

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Project description:Background:We previously demonstrated that brentuximab vedotin (BV) used as second-line therapy in patients with Hodgkin lymphoma is a tolerable and effective bridge to autologous hematopoietic cell transplantation (AHCT). Here, we report the post-AHCT outcomes of patients treated with second-line standard/fixed-dose BV and an additional cohort of patients where positron-emission tomography adapted dose-escalation of second-line BV was utilized. Patients and methods:Patients on the dose-escalation cohort received 1.8?mg/kg of BV intravenously every 3?weeks for two cycles. Patients in complete remission (CR) after two cycles received two additional cycles of BV at 1.8?mg/kg, while patients with stable disease or partial response were escalated to 2.4?mg/kg for two cycles. All patients, regardless of treatment cohort, proceeded directly to AHCT or received additional pre-AHCT therapy at the discretion of the treating physician based on remission status after second-line BV. Results:Of the 20 patients enrolled to the BV dose-escalation cohort, 8 patients underwent BV dose-escalation. BV escalation was well-tolerated, but no patients who were escalated converted to CR. Of 56 evaluable patients treated across cohorts, the overall response rate (ORR) to second-line BV was 75% with 43% CR. Twenty-eight (50%) patients proceeded directly to AHCT without post-BV chemotherapy, and a total of 50 patients proceeded to AHCT. Thirteen patients received consolidative post-AHCT therapy with either radiation, BV, or a PD-1 inhibitor. After AHCT, the 2-year progression-free survival (PFS) and overall survival were 67% and 93%, respectively. The 2-year PFS among patients in CR at the time of AHCT (n?=?37) was 71% compared with 54% in patients not in CR (p?=?0.12). The 2-year PFS in patients who proceeded to AHCT directly after receiving BV alone was 77%. Conclusions:Second-line BV is an effective bridge to AHCT that produces responses of sufficient depth to provide durable remission in conjunction with AHCT (clinicaltrials.gov: NCT01393717).

Dataset Information

Role of brentuximab vedotin in the treatment of relapsed or refractory Hodgkin lymphoma.

Publications

Role of brentuximab vedotin in the treatment of relapsed or refractory Hodgkin lymphoma.

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