High objective response and complete response rates were observed with treatment with brentuximab vedotin and nivolumab in combination with doxorubicin and dacarbazine chemotherapy in patients with early-stage classical Hodgkin lymphoma, according to the results of a phase II trial published in Blood.
“We are pleased with these outcomes, which were consistent across both favorable- and unfavorable-risk groups,” said leading investigator Hun Lee, MD, Associate Professor of Lymphoma, The University of Texas MD Anderson Cancer Center. “Our ability to omit several medications and radiation therapy demonstrates that we can maintain or improve outcomes and reduce treatment toxicity.”
Background and Study Methods
Researchers believe that adjusting the approval regimen of brentuximab vedotin plus doxorubicin, vinblastine, and dacarbazine by adding in more modern therapies and removing some of the chemotherapy combinations could improve safety while maintaining efficacy in patients with early-stage classic Hodgkin lymphoma.
A team explored the combination of brentuximab vedotin and nivolumab plus doxorubicin and dacarbazine in a phase II study in patients with nonbulky (< 10 cm) Ann Arbor stage I or II classical Hodgkin lymphoma. In the study, all patients received four cycles of the combination regimen. The primary endpoint was complete response rate at the end of treatment.
A total of 154 patients had received at least one dose of the combination regimen at the time of the analysis.
Key Findings
The objective response rate at the end of treatment was 96% (95% confidence interval [CI] = 91.7%–98.6%) and the complete response rate was 92% (95% CI = 86%–95.4%). Complete responses lasted at least 2 years in 96% of patients (95% CI = 90.9%–98.4%).
When assessed by favorable (n = 56) or unfavorable (n = 97) disease characteristics, the complete response rate was 95% (95% CI = 85.1%–98.9%) in the favorable subgroup and 91% (95% CI = 83.1%–95.7%) in the unfavorable subgroup.
The estimated progression-free survival rate at 2 years was 97% (95% CI = 92.0%–98.8%).
In terms of safety, any-grade treatment-emergent adverse events were reported in 99% of patients and grade ≥ 3 events in 44%. There were no cases of febrile neutropenia noted in the study.
Any-grade treatment-emergent immune-mediated adverse events were reported in 22% of patients.
One death related to treatment was reported after the safety reporting period was concluded.
DISCLOSURES: The study was funded by Pfizer and Bristol Myers Squibb. For full disclosures of the study authors, visit ashpublications.org.
