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Brentuximab vedotin in combination with nivolumab in relapsed or refractory Hodgkin lymphoma: 3-year study results
- Source :
- Blood. 138(6)
- Publication Year :
- 2020
-
Abstract
- This phase 1-2 study evaluated brentuximab vedotin (BV) combined with nivolumab (Nivo) 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 BV and Nivo 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 (AEs) 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 AEs 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 BV and Nivo as a first salvage regimen shows durable efficacy and impressive PFS, especially in patients who proceeded directly to transplant, without additional toxicity concerns. This trial was registered at www.clinicaltrials.gov as #NCT02572167.
- Subjects :
- Adult
Male
medicine.medical_specialty
Adolescent
Nausea
Immunology
Salvage therapy
Biochemistry
Gastroenterology
Disease-Free Survival
Autologous stem-cell transplantation
Refractory
Recurrence
Internal medicine
Antineoplastic Combined Chemotherapy Protocols
medicine
Refractory Hodgkin Lymphoma
Humans
Adverse effect
Brentuximab vedotin
Aged
Brentuximab Vedotin
business.industry
Cell Biology
Hematology
Middle Aged
Hodgkin Disease
Survival Rate
Nivolumab
Female
medicine.symptom
business
medicine.drug
Follow-Up Studies
Subjects
Details
- ISSN :
- 15280020
- Volume :
- 138
- Issue :
- 6
- Database :
- OpenAIRE
- Journal :
- Blood
- Accession number :
- edsair.doi.dedup.....d15b0eafd5b59fffb7b5f819a434b4bc