Phase I/II HALO trial: First-line brentuximab vedotin + bendamustine in elderly patients with cHL

Results from the prospective, open-label, phase I/II HALO (NCT02467946) trial, evaluating brentuximab vedotin + bendamustine as first-line treatment in 60 elderly patients (aged 60–80 years) with advanced-stage classical Hodgkin lymphoma (cHL), were published in the British Journal of Haematology by Gallamini et al. The primary endpoints during phases I and II were safety and efficacy, respectively. 

Key data: In 57 evaluable patients, the most common non-infectious Grade ≥3 severe adverse events (AEs) during treatment were lymphopenia (29.9%), neutropenia (19.4%), cutaneous disorders (4.7%), leucopenia (2.8%), thrombocytopenia (1.9%), and infusion-related reactions (1.9%). Cytomegalovirus (CMV) infection was documented in 5.6% of patients, with CMV reactivation in 32%. Overall, 25 patients died. Causes of death included recurrent cHL (n = 8), secondary malignancy (n = 3), sepsis (n = 1), unknown toxicity (n = 1), respiratory failure (n = 1), and unknown (n = 11). In an intention-to-treat (ITT) analysis (n = 57), a complete metabolic response (CMR) was attained in 79% of patients. The 6-year overall survival (OS) and progression-free survival (PFS) rates were 56% (95% confidence interval [CI], 44–72) and 36% (95% CI, 25–52), respectively, in the ITT analysis, and 67% (95% CI, 53–84) and 45% (95% CI, 32–65), respectively, in the per-protocol analysis.

Key learning: In the HALO trial, brentuximab vedotin + bendamustine demonstrated meaningful efficacy as first-line treatment in elderly patients with advanced-stage cHL, though the incidence of CMV reactivation warrants careful monitoring.