Phase II Trial of Pembrolizumab Plus Gemcitabine, Vinorelbine, and Liposomal Doxorubicin as Second-Line Therapy for Relapsed or Refractory Classical Hodgkin Lymphoma.
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Moskowitz Alison J, Shah Gunjan, Schöder Heiko, Ganesan Nivetha, Drill Esther, Hancock Helen, Davey Theresa, Perez Leslie, Ryu Sunyoung, Sohail Samia, Santarosa Alayna, Galasso Natasha, Neuman Rachel, Liotta Brielle, Blouin William, Kumar Anita, Lahoud Oscar, Batlevi Connie L, Hamlin Paul, Straus David J, Rodriguez-Rivera Ildefonso, Owens Colette, Caron Philip, Intlekofer Andrew M, Hamilton Audrey, Horwitz Steven M, Falchi Lorenzo, Joffe Erel, Johnson William, Lee Christina, Palomba M Lia, Noy Ariela, Matasar Matthew J, Pongas Georgios, Salles Gilles, Vardhana Santosha, Sanin Beatriz Wills, von Keudell Gottfried, Yahalom Joachim, Dogan Ahmet, Zelenetz Andrew D, Moskowitz Craig H
Аннотация
METHODS: Transplant eligible patients with rel/ref cHL following first-line therapy were treated with two to four cycles of pembrolizumab (200 mg intravenous [IV], day 1), gemcitabine (1,000 mg/m2 IV, days 1 and 8), vinorelbine (20 mg/m2 IV, days 1 and 8), and liposomal doxorubicin (15 mg/m2, days 1 and 8), given on 21-day cycles. The primary end point was complete response (CR) following up to four cycles of pembro-GVD. Patients who achieved CR by labeled fluorodeoxyglucose-positron emission tomography (Deauville ≤ 3) after two or four cycles proceeded to high-dose therapy and autologous hematopoietic cell transplantation (HDT/AHCT). HDT/AHCT was carried out according to institutional standards, and brentuximab vedotin maintenance was allowed following HDT/AHCT.
RESULTS: Of 39 patients enrolled, 41% had primary ref disease and 38% relapsed within 1 year of frontline treatment. 31 patients received two cycles of pembro-GVD, and eight received four cycles. Most adverse events were grade 1 or two, whereas few were grade 3 and included transaminitis (n = 4), neutropenia (n = 4), mucositis (n = 2), thyroiditis (n = 1), and rash (n = 1). Of 38 evaluable patients, overall and CR rates after pembro-GVD were 100% and 95%, respectively. Thirty-six (95%) patients proceeded to HDT/AHCT, two received pre-HDT/AHCT involved site radiation, and 13 (33%) received post-HDT/AHCT brentuximab vedotin maintenance. All 36 transplanted patients are in remission at a median post-transplant follow-up of 13.5 months (range: 2.66-27.06 months).
CONCLUSION: Second-line therapy with pembro-GVD is a highly effective and well-tolerated regimen that can efficiently bridge patients with rel/ref cHL to HDT/AHCT.