PracticeUpdate: Haematology & Oncology

ASH 2016 15

P = 0.89), and the outcomes in terms of overall survival are similar as well (HR, 1.19; P = 0.40). No difference in event-free or overall survival was found between R-CHOP and DA-EPOCH, although DA-EPOCH-R was associated with higher toxicity, likely related to the higher dose, and fewer participants completed the therapy than completed R-CHOP. Abstract 470: Obinutuzumab or rituximab plus CHOP in patients with previously untreated diffuse large B-cell lymphoma: final results from an open-label, randomized phase 3 study (GOYA). U Vitolo, M Trněný, D Belada, et al The phase 3 GOYA study (n=1418) evaluated the efficacy and safety of obinutuzumab (G) vs rituximab (R) plus CHOP in patients with DLBCL. Participants were 18 years old or older with comparable baseline traits and were randomised to either G-CHOP (n=706) or R-CHOP (n=712). There was no marked difference between the two groups for the primary endpoint of investigator-assessed PFS or for secondary endpoints, including end-of- treatment ORR/CR rate. More grade ≥ 3 AEs were reported for patients in the G-CHOP than R-CHOP arm, and include neutropenia (57% vs 48%) and thrombocytopenia (8% vs 3%). Mortality rates were higher and withdrawal from treatment more common in the G-CHOP arm. There was no significant improvement in investigator-assessed PFS for G-CHOP com- pared with R-CHOP in patients with DLBCL who had no prior treatment. No unforeseen safety indicators were detected, and further work is planned to examine outcomes in subgroups. Mantle cell, follicular, and other indolent B-cell lymphoma – clinical studies Abstract 1100: Chimeric antigen receptor modified T cells directed against CD19 (CTL019) in patients with poor prognosis, relapsed or refractory CD19+ follicular lymphoma: prolonged remissions relative to antecedent therapy. EA Chong, J Svoboda, SD Nasta, et al This ongoing trial has, to date, enrolled 14 patients with follicular lymphoma (9 with grade 1–2 disease and 5 with grade 3a). The participants are a median age of 59 years, and the gender split is 7:7. The median number of prior treatments is 5; 3 of the 14 patients have undergone transplant. All of the patients had previously received rituximab as a mono- or combination therapy. No participants received further treatment after CTL019 cell infusion. ORR at 3 months was 79% (11 patients), with CR observed in half of the participants (7 patients). At 6-month response assessment, 2 of 3 patients with PR

Treatment with KTE-C19 is associated with a marked clinical advantage in patients without curative treatment options. This study is the first trial to report results with CAR T-cell therapy in patients with refractory aggressive NHL, with successful implementation across 22 sites.

converted to CR; 9 of the 14 patients (64%) have CR. PFS is 77% at the median follow-up of 11.4 months from infusion. Results indicate that a single treatment with CTL019 cells can improve on the time to the next treatment (compared with prior treatment). Hodgkin lymphoma and T/NK cell lymphoma – clinical studies Abstract 1107: Pembrolizumab in relapsed/ refractory classical Hodgkin lymphoma: primary end point analysis of the phase 2 Keynote-087 study. CH Moskowitz, PL Zinzani, MA Fanale, et al The phase 2 KEYNOTE-087 study (n=210) is an efficacy and safety evaluation of pem- brolizumab. Allocation to the three cohort groups was determined by a patient’s eligi- bility for ASCT therapy and/or subsequent treatments (cohort 1, n=69; cohort 2, n=81; cohort 3, n=60). All patients had relapsed or refractory (R/R) classical Hodgkin’s lympho- ma and received pembrolizumab 200 mg IV at 3-week intervals with follow-up at 12 weeks. The endpoint ORR per investigative review was reported as 66.7% (cohort 1, 46 patients), 65.4% (cohort 2, 53 patients), and 68.3% (cohort 3, 41 patients), with CRR reported as 29.0%, 24.7%, and 21.7%, respectively. The ORR endpoint per blind independent central review was 72.5%, 65.4%, and 66.7%, with CRRs of 21.7%, 22.2%, and 21.7%, for cohorts 1, 2, and 3, respectively. Find- ings reveal a reduction in tumour size from baseline across all three cohorts (93.7%; 192 patients). The 2 deaths were not attributed to treatment. Results show high levels of clinical activity with pembrolizumab in patients with classical Hodgkin’s who had undergone substantial pri- or treatment, in particular, inducing a high ORR. Additional results to be presented include biomarker analysis. Abstract 1110: Checkmate 205 update with minimum 12-month follow up: a phase 2 study of nivolumab in patients with relapsed/ refractory classical Hodgkin lymphoma. J Timmerman, A Engert, A Younes, et al The phase 2 CheckMate 205 study provides an evaluation of nivolumab as a monotherapy in patients with classical Hodgkin’s lymphoma after failedASCT therapy. Patients from three cohorts took part in the investigation: 205A

(brentuximab vedotin [BV]–naive; n=63); 205B (BV after failed ASCT; n=80); and 205C (BV before study drug; n=100). The authors report longer (minimum 12 months) follow-up in cohort 205B, which is discussed here. Nivolumab was administered at a dose of 3 mg/kg IV every 2 weeks until progression or unacceptable toxicity. IRRC-assessed ORR (the primary endpoint) was 68% in the 205B group; CR and PR were 8% and 60%, respectively. Treatment was stopped for 37 patients for reasons including progression of disease and adverse events. Treatment-related AEs included rash (15%), and fatigue (28%), and severe AEs were reported to include pyrexia, pneumonia, tumour progression, and meningitis. Study results reveal that nivolumab displays an acceptable safety profile, and extended remissions were evident. Late-breaking abstracts session LBA-6: KTE-C19 (anti-CD19 CAR T Cells) induces complete remissions in patients with refractory diffuse large B-cell lymphoma (DLBCL): Results from the pivotal phase 2 ZUMA-1. SS Neelapu, FL Locke, NL Bartlett, et al Phase 2 of the ZUMA-1 trial of anti-CD19 CAR T cells in patients with aggressive and refractory non-Hodgkin’s lymphoma (NHL) includes two cohorts. In this presentation, the authors give an interim report for the cohort 1 (DLBCL) participants eligible for analysis (n=51). Following a conditioning regimen, participants were given a target dose of 2 × 10 6 anti-CD19 CAR T cells/kg. The primary endpoint (ORR per the 2007 IWG criteria) was met by 76% of the cohort (P < 0.0001); 47% and 29% achieved CR and PR, respectively. Responses were observed for subgroups refractory to chemotherapy (76%) and in whom relapse occurred post- ASCT (80%). Estimates of PFS are stated as 92% and 56% at 1 month and 3 months, respectively. Grade ≥ 3 treatment-relatedAEs included neutropenia (67%), anaemia (39%), and encephalopathy (24%); cytokine-release syndrome was evident in 20% of patients. Treatment with KTE-C19 is associated with a marked clinical advantage in patients without curative treatment options. This study is the first trial to report results with CAR T-cell therapy in patients with refractory aggressive NHL, with successful implementation across 22 sites.

VOL. 2 • NO. 1 • 2017