PMID- 33827139 OWN - NLM STAT- MEDLINE DCOM- 20211203 LR - 20211214 IS - 1528-0020 (Electronic) IS - 0006-4971 (Linking) VI - 138 IP - 6 DP - 2021 Aug 12 TI - Brentuximab vedotin in combination with nivolumab in relapsed or refractory Hodgkin lymphoma: 3-year study results. PG - 427-438 LID - 10.1182/blood.2020009178 [doi] AB - 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. CI - (c) 2021 by The American Society of Hematology. FAU - Advani, Ranjana H AU - Advani RH AD - Stanford University Medical Center, Palo Alto, CA. FAU - Moskowitz, Alison J AU - Moskowitz AJ AD - Memorial Sloan Kettering Cancer Center, New York, NY. FAU - Bartlett, Nancy L AU - Bartlett NL AUID- ORCID: 0000-0001-8470-394X AD - Department of Medicine, Washington University, St Louis, MO. FAU - Vose, Julie M AU - Vose JM AUID- ORCID: 0000-0003-1015-7434 AD - University of Nebraska Medical Center, Omaha, NE. FAU - Ramchandren, Radhakrishnan AU - Ramchandren R AD - Karmanos Cancer Institute, Detroit, MI. FAU - Feldman, Tatyana A AU - Feldman TA AD - Hackensack University Medical Center, Hackensack, NJ. FAU - LaCasce, Ann S AU - LaCasce AS AUID- ORCID: 0000-0001-7349-0176 AD - Dana-Farber Cancer Institute, Boston, MA. FAU - Christian, Beth A AU - Christian BA AD - James Cancer Hospital, Columbus, OH. FAU - Ansell, Stephen M AU - Ansell SM AD - Mayo Clinic, Rochester, MN. FAU - Moskowitz, Craig H AU - Moskowitz CH AD - Sylvester Comprehensive Cancer Center, University of Miami, Miami, FL. FAU - Brown, Lisa AU - Brown L AD - Seagen Inc, Bothell, WA. FAU - Zhang, Chiyu AU - Zhang C AD - Seagen Inc, Bothell, WA. FAU - Taft, David AU - Taft D AD - Seagen Inc, Bothell, WA. FAU - Ansari, Sahar AU - Ansari S AD - Seagen Inc, Bothell, WA. FAU - Sacchi, Mariana AU - Sacchi M AD - Bristol-Myers Squibb, Princeton, NJ; and. FAU - Ho, Linda AU - Ho L AD - Seagen Inc, Bothell, WA. FAU - Herrera, Alex F AU - Herrera AF AD - City of Hope National Medical Center, Duarte, CA. LA - eng SI - ClinicalTrials.gov/NCT02572167 PT - Clinical Trial, Phase I PT - Clinical Trial, Phase II PT - Journal Article PT - Multicenter Study PT - Research Support, Non-U.S. Gov't PL - United States TA - Blood JT - Blood JID - 7603509 RN - 31YO63LBSN (Nivolumab) RN - 7XL5ISS668 (Brentuximab Vedotin) SB - IM CIN - Blood. 2021 Aug 12;138(6):421-422. PMID: 34383039 MH - Adolescent MH - Adult MH - Aged MH - Antineoplastic Combined Chemotherapy Protocols/*administration & dosage MH - Brentuximab Vedotin/administration & dosage MH - Disease-Free Survival MH - Female MH - Follow-Up Studies MH - Hodgkin Disease/*drug therapy/*mortality MH - Humans MH - Male MH - Middle Aged MH - Nivolumab/administration & dosage MH - Recurrence MH - Survival Rate EDAT- 2021/04/08 06:00 MHDA- 2021/12/15 06:00 CRDT- 2021/04/07 20:17 PHST- 2020/09/25 00:00 [received] PHST- 2021/03/18 00:00 [accepted] PHST- 2021/04/08 06:00 [pubmed] PHST- 2021/12/15 06:00 [medline] PHST- 2021/04/07 20:17 [entrez] AID - S0006-4971(21)00797-7 [pii] AID - 10.1182/blood.2020009178 [doi] PST - ppublish SO - Blood. 2021 Aug 12;138(6):427-438. doi: 10.1182/blood.2020009178.