Nivolumab with or without vinblastine for first-line treatment of elderly patients with Hodgkin lymphoma and coexisting medical conditions: the Niviniho phase II Lysa study

The prognosis of elderly patients with Hodgkin lymphoma (HL) unfit for conventional chemotherapy remains poor. We report the results of the LYSA phase II NIVINIHO trial in treatment-naive HL patients aged ≥ 61 years with comorbidities contraindicating standard chemotherapy. Treatment included an induction phase with nivolumab alone, followed by a consolidation phase: either nivolumab monotherapy for patients with early complete metabolic response or nivolumab plus vinblastine for patients with stable disease or partial response. The primary objective of the study was the complete metabolic response (CMR) rate at the end of treatment. From August 2018 to April 2020, 64 patients were enrolled. Median age was 75.0 (range, 62 to 91) years, Ann Arbor stage was advanced (stage III-IV) in 75.0% of patients. At end of nivolumab induction, 11 patients (17.2%) achieved CMR and were consolidated with nivolumab alone, 23 (35.9%) patients obtained PMR or SD and received vinblastine plus nivolumab. Among the 56 evaluable patients, 16 (28.6%) achieved CMR at the end of treatment. With a median follow-up of 24.4 months (range, 0.9 to 35.2), median progression-free survival (PFS) was 9.8 months (95% confidence interval [CI], 4.2 to 12) while the 2-year overall survival (OS) rate was 74.1% (95%CI, 58.9% to 84.4%). Thirtytwo patients (50%) experienced grade ≥ 3 adverse events (AEs). Nivolumab-related adverse events led to treatment discontinuation in 19 patients (29.7%). Our results show that nivolumab can be administrated to elderly, frail patients unfit for classical chemotherapy; however, the objective response rate with monotherapy remains low. Trial registration number: NCT03580408.