Background
Phase II open-label single-arm study (n=91) of brentuximab vedotin + nivolumab in relapsed/refractory classical Hodgkin lymphoma, predominantly first relapse. 60% were ASCT-naive at enrollment. The study tested whether anti-CD30 ADC + PD-1 blockade could achieve high CR rates to bridge to ASCT.
Interventions and follow up
Regimen: Brentuximab vedotin 1.8 mg/kg IV + nivolumab 3 mg/kg IV q3w × 4 cycles, response assessment after 4 cycles; responders could continue up to 16 cycles or proceed to ASCT
Primary endpoint: ORR (CR + PR) by independent review
Median follow up: 3 years
Primary endpoint: ORR (CR + PR) by independent review
Median follow up: 3 years
Results
ORR: 85%
CR rate: 67%
3-yr PFS (all patients): 77%
3-yr PFS (patients proceeding to ASCT): 91%
3-yr OS: 93%
CR rate: 67%
3-yr PFS (all patients): 77%
3-yr PFS (patients proceeding to ASCT): 91%
3-yr OS: 93%
Adverse events
Overall: grade ≥3 AEs 44%; infusion reactions 12%; febrile neutropenia 11%; treatment discontinuations 5%
Neurologic: peripheral neuropathy any grade 46% (grade ≥3 3%)
Immune-mediated: pneumonitis 6.6%, hypothyroidism 5.5%, rash 4.4%
Neurologic: peripheral neuropathy any grade 46% (grade ≥3 3%)
Immune-mediated: pneumonitis 6.6%, hypothyroidism 5.5%, rash 4.4%
Conclusions
BV+nivolumab achieved an 85% ORR and 67% CR rate in R/R cHL — substantially higher than either agent alone — with 91% 3-yr PFS in patients bridged to ASCT. Now widely used as first salvage for transplant-eligible R/R cHL.
Key Limitations
Single-arm phase II without a comparator, limiting controlled efficacy inference. No direct randomized comparison with pembro-GVD (high CR rate) exists. The patient population was mostly fit, first-relapse patients, limiting generalizability to heavily pretreated or older patients. BV-related peripheral neuropathy (46% any grade) remains a meaningful concern, and the optimal duration/sequencing relative to ASCT is not defined.
Clinical Context
BV+nivolumab is a widely used first salvage regimen for transplant-eligible R/R cHL, achieving deep remissions that facilitate ASCT consolidation. It competes with pembro-GVD (high CR rate); both are accepted salvage options per ESMO/ASCO-aligned practice. Randomized head-to-head comparisons are lacking, and regimen selection is individualized by toxicity profile and institutional preference.