From the Journals

Brentuximab vedotin plus nivolumab shows positive outcomes in PMBL


 

FROM THE JOURNAL OF CLINICAL ONCOLOGY

Combination brentuximab vedotin and nivolumab showed manageable safety and high activity in patients with relapsed/refractory primary mediastinal B-cell lymphoma (PMBL), according to results from a phase 2 trial.

“We evaluated whether the combination of nivolumab and [brentuximab vedotin] was safe and synergistically effective in patients with [relapsed/refractory] PMBL,” Pier Luigi Zinzani, MD, PhD, of the University of Bologna (Italy), and colleagues wrote in the Journal of Clinical Oncology.

The CheckMate 436 study is a multicenter, open-label, phase 1-2 study that included patients with relapsed/refractory disease who had previously received autologous stem cell transplantation (ASCT) or had two or more previous chemotherapy regimens for those ineligible for ASCT.

The phase 2 component evaluated the safety and efficacy of the two-drug combo in an expansion cohort of 30 patients. Study participants received intravenous brentuximab vedotin at 1.8 mg/kg and nivolumab at 240 mg every 3 weeks until cancer progression or intolerable adverse effects.

The primary outcomes were the investigator-evaluated objective response rate and safety. Secondary outcomes included progression-free survival, complete remission rate, overall duration of response, among other measures.

After analysis, the researchers reported that 53% of patients had grade 3 or 4 treatment-related toxicities following a median of five treatment cycles. The most common treatment-related toxicities were neutropenia (30%) and peripheral neuropathy (27%).

Five patients died during the study follow-up, four because of disease progression and one as a result of sepsis that was not considered related to treatment.

At a median follow-up of 11.1 months, the objective response rate was 73% in study participants, including 11 patients (37%) who achieved a complete response and 11 patients (37%) who had a partial response. An additional three patients had stable disease.

The median progression-free survival, duration of response, and overall survival were not reached in this study.

“The combination of nivolumab and [brentuximab vedotin] may be synergistic and is highly active in patients with [relapsed/refractory] PMBL, serving as a potential bridge to other consolidative therapies of curative intent,” the researchers wrote.

The study was funded by Bristol-Myers Squibb and Seattle Genetics. The authors reported financial affiliations with the study sponsors and several other companies.

SOURCE: Zinzani PL et al. J Clin Oncol. 2019 Aug 9. doi: 10.1200/JCO.19.01492.

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