Brentuximab vedotin in combination with nivolumab in relapsed or refractory Hodgkin lymphoma: 3-year study results
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- Ranjana H. Advani
- Stanford University Medical Center, Palo Alto, CA;
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- Alison J. Moskowitz
- Memorial Sloan Kettering Cancer Center, New York, NY;
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- Nancy L. Bartlett
- Department of Medicine, Washington University, St Louis, MO;
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- Julie M. Vose
- University of Nebraska Medical Center, Omaha, NE;
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- Radhakrishnan Ramchandren
- Karmanos Cancer Institute, Detroit, MI;
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- Tatyana A. Feldman
- Hackensack University Medical Center, Hackensack, NJ;
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- Ann S. LaCasce
- Dana-Farber Cancer Institute, Boston, MA;
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- Beth A. Christian
- James Cancer Hospital, Columbus, OH;
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- Stephen M. Ansell
- Mayo Clinic, Rochester, MN;
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- Craig H. Moskowitz
- Sylvester Comprehensive Cancer Center, University of Miami, Miami, FL;
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- Lisa Brown
- Seagen Inc, Bothell, WA;
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- Chiyu Zhang
- Seagen Inc, Bothell, WA;
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- David Taft
- Seagen Inc, Bothell, WA;
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- Sahar Ansari
- Seagen Inc, Bothell, WA;
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- Mariana Sacchi
- Bristol-Myers Squibb, Princeton, NJ; and
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- Linda Ho
- Seagen Inc, Bothell, WA;
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- Alex F. Herrera
- City of Hope National Medical Center, Duarte, CA
抄録
<jats:title>Abstract</jats:title><jats:p>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.</jats:p>
収録刊行物
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- Blood
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Blood 138 (6), 427-438, 2021-04-07
American Society of Hematology