A phase 1-2 study evaluated Brentuximab vedotin ( Adcetris ) combined with Nivolumab ( Opdivo ) as first salvage therapy in patients with relapsed/refractory ( r/r ) classical Hodgkin lymphoma ( cHL ).
In parts 1 and 2, patients received staggered dosing of Brentuximab vedotin and Nivolumab in cycle 1, followed by same-day dosing in cycles 2 to 4.
In part 3, both study drugs were dosed, same day, for all 4 cycles.
At end of study treatment, patients could undergo autologous stem cell transplantation ( ASCT ) per investigator discretion.
The objective response rate ( ORR; N = 91 ) was 85%, with 67% achieving a complete response ( CR ).
At a median follow-up of 34.3 months, the estimated progression-free survival ( PFS ) rate at 3 years was 77% ( 95% confidence interval [ CI ], 65% to 86% ) and 91% ( 95% CI, 79% to 96% ) for patients undergoing ASCT directly after study treatment.
Overall survival at 3 years was 93% ( 95% CI, 85% to 97% ).
The most common adverse events prior to ASCT were nausea ( 52% ) and infusion-related reactions ( 43% ), all grade 1 or 2.
A total of 16 patients (18%) had immune-related adverse effects that required systemic corticosteroid treatment.
Peripheral blood immune signatures were consistent with an activated T-cell response.
Median gene expression of CD30 in tumors was higher in patients who responded compared with those who did not.
Longer-term follow-up of Brentuximab vedotin and Nivolumab as a first salvage regimen ha shown durable efficacy and impressive progression-free survival, especially in patients who proceeded directly to transplant, without additional toxicity concerns. ( Xagena )
Advani RH et al, Blood 2021; DOI: 10.1182/blood.2020010387.