Phase II SGN35-027 trial: AN + AD for early-stage cHL

Results from the randomized, international phase II SGN35‑027 trial (NCT03646123) evaluating the efficacy and safety of brentuximab vedotin + nivolumab + doxorubicin + dacarbazine (AN + AD) in patients with non-bulky, early-stage classical Hodgkin lymphoma (cHL; n = 154) were recently published in Blood by Abramson et al. The primary endpoint was the complete response (CR) rate at the end of treatment. Secondary endpoints included safety, tolerability, overall response rate (ORR), duration of response (DoR), duration of CR (DoCR), event-free survival, progression-free survival (PFS), and overall survival (OS).

Key data: The CR rate at the end of treatment was 92% (95% confidence interval [CI], 86.0–95.4), with an ORR of 96% (95% CI, 91.7–98.6). The estimated 2-year DoR was 96%, with 96% (95% CI, 90.9–98.4) of patients achieving a DoCR ≥2 years. At a median follow-up of 27.9 months, the estimated 2-year PFS rate was 97% (95% CI, 92.0–98.8). At a median follow-up of 30.9 months (95% CI, 29.0–32.4), one OS event was reported. Grade ≥3 treatment-emergent adverse events (TEAEs) occurred in 44% of patients, with no events of febrile neutropenia reported. The most common treatment-related adverse events (TRAEs) of any grade were nausea (65%), peripheral sensory neuropathy (47%), fatigue (44%), constipation (29%), and alopecia (22%).

Key learning: AN + AD demonstrated consistent efficacy compared with current standard of care regimens for early-stage cHL with a manageable safety profile. These results support the use of brentuximab vedotin + nivolumab in combination with limited chemotherapy in patients with early-stage cHL.