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.

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Journal
Haematologica
Published
2026-05-28
DOI
https://doi.org/10.3324/haematol.2025.300166
Primary Topic
Lymphoma Diagnosis and Treatment
Type
article
Field-Weighted Citation Impact
0.00

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article

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

Véronique Edeline, Baptiste Delapierre, Anne Corby, Alina Berriolo-Riedinger et al.
Haematologica
Lymphoma Diagnosis and Treatment
article

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

Véronique Edeline, Baptiste Delapierre, Anne Corby, Alina Berriolo-Riedinger, Olivier Casasnovas, Thomas Gastinne, Marguerite Fournier, Diane Damotte, Ribrag, Vincent Launay, Bohrane Slama, David Sibon, Julien Lazarovici, Sandy Amorim, Thierry Vander Borght, Kamel Laribi, Nawel Belmecheri, Alexandra Traverse-Glehen, Pierre Feugier, Emmanuelle Nicolas-Virelizie, Franck Morschhauser, Stéphanie Guidez, Eric Durot, Lysiane Molina, Marc André, Krimo Bouabdallah
article en

Abstract

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.

Haematologica
Hôpital Necker-Enfants Malades (FR), Université Paris Cité (FR), Centre Hospitalier Universitaire de Grenoble (FR), Institut Gustave Roussy (FR), Centre Hospitalier Universitaire de Nantes (FR), Sorbonne Paris Cité (FR), CHU Dinant Godinne UCL Namur (BE), Centre Georges François Leclerc (FR), Centre Hospitalier Régional et Universitaire de Nancy (FR), Hospices Civils de Lyon (FR), Centre Hospitalier de Saint-Brieuc (FR), Centre Léon Bérard (FR), Centre Hospitalier Universitaire de Reims (FR), The Lymphoma Academic Research Organisation (FR), Centre Hospitalier Universitaire de Poitiers (FR), Hôpital Lyon Sud (FR), CHU Dijon Bourgogne (FR), Laboratoire Informatique d'Avignon (FR), Hôpital Cardiologique du Haut-Lévêque (FR), Centre de Recherche en Cancérologie de Lyon (FR), Centre Hospitalier du Mans (FR), Centre d'Investigation Clinique de Nantes (FR), Centre Hospitalier de La Rochelle (FR), Institut Paoli-Calmettes (FR), Hôpital Claude Huriez (FR), Hôpital Saint-Vincent-de-Paul (FR), UCLouvain (BE), Université de Reims Champagne-Ardenne (FR)
Eli Lilly and Company, Gilead Sciences, Astex Pharmaceuticals, BeiGene, Ipsen
No poverty
Openalex Percentile: Top 6%
Lymphoma Diagnosis and Treatment
DOIOpen Access PDFOpenAlex
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