ASH Clinical News August 2016 | Page 35

CLINICAL NEWS On Location American Society of Hematology’s MEETING ON LYMPHOMA BIOLOGY he 2016 ASH Meeting on Lymphoma Biology brought together experts from around the world to discuss the latest breakthroughs in basic and translational lymphoma research. Here, we present research highlights from the meeting, including ibrutinib in high-risk chronic lymphocytic leukemia and the EZH2 inhibitor tazemetostat in previously treated non-Hodgkin lymphoma. The meeting’s smaller format provided a forum for scientific exchange and fostered networking and collaboration among lymphoma researchers. The four-day event features didactic sessions, abstract presentations, interactive workshops, and continuing conversations. Ibrutinib Shows Survival Benefit in Previously Treated CLL/SLL Patients with High-Risk Disease Longer-term data from the phase III RESONATE trial – a head-to-head comparison of ibrutinib and ofatumumab – continue to demonstrate ibrutinib’s efficacy in patients with previously treated chronic lymphocytic leukemia (CLL), according to data presented at the 2016 ASH Meeting on Lymphoma Biology. The benefits also appear to extend to patients with high-risk genetic mutations and poorer prognoses. Historically, CLL with p53 dysfunction or del17p has been difficult to treat, with few available therapeutic options, according to Jennifer R. Brown, MD, PhD, director of the CLL Center at Dana-Farber Cancer Center and associate professor of medicine at Harvard Medical School, and first author of the study. With the advent of novel inhibitors, this may be changing. “These targeted therapies appear to be more effective against CLL with p53 mutation and del17p, which is the highest risk group [of patients],” Dr. Brown told ASH Clinical News, “but there is still a question as to whether they completely reverse that adverse prognosis.” To this end, Dr. Brown and her team examined two- year progression-free survival (PFS), overall survival (OS), and overall response rate (ORR) among patients with these high-risk gene mutations enrolled in the RESONATE trial. They also included patients who had NOTCH1, BIRC3, and SF3B1 mutations – newly identified mutations also associated with worse survival in CLL. RESONATE included 391 patients with relapsed or refractory CLL or small lymphocytic leukemia (SLL) who received at least one previous anti-cancer therapy. Patients were randomized to receive oral ibrutinib 420 mg (n=142) or intravenous ofatumumab (n=196) for up to 24 weeks. REFERENCE At 18-months of follow-up, 76 percent of ibrutinibBrown JR, Hillmen P, O’Brien S, et al. Efficacy of ibrutinib by baseline high-risk genetic features, treated patients had not experienced disease progression, including novel gene mutations, and safety with longer follow-up from the phase 3 RESONATETM compared with eight percent in the ofatumumab-treated trial in previously treated CLL/SLL. Abstract #88509. Presented at the 2016 ASH Meeting on Lymphoma Biology, June 20, 2016; Colorado Springs, CO. group. ORR was also higher with ibrutinib compared with ofatumumab (90% vs. 25%; p value not reported), regardless of baseline genetic mutations (TABLE 1). AdTABLE 2. Progression-Free Survival and Overall Response ditionally, patients who received one Rate Among Patients with Novel Genetic Mutations prior therapy fared significantly better   Progression-Free Survival and Overall Response Rate by Subgroup TABLE 1.   18-Month Progression-Free Survival Overall Response Rate Ibrutinib (n=142) Ofatumumab (n=149) Ibrutinib (n=142) Ofatumumab (n=149) ATM Mutated 77% 0 26/28 (93%) 8/33 (24%) Unmutated 77% 8% 106/114 (93%) 32/116 (28%) Mutated 77% 0 37/40 (93%) 13/45 (29%) Unmutated 77% 11% 95/102 (93%) 27/104 (26%) Mutated 65% 10% 42/43 (98%) 10/44 (23%) Unmutated 83% 0 90/99 (91%) 30/105 (29%) Mutated 73% 0 67/72 (93%) 13/68 (19%) Unmutated 82% 9% 65/70 (93%) 27/81 (33%) Ofatumumab (n=196) Ibrutinib (n=195) Ofatumumab (n=196) 76% 8% 90% 25% 1 91% 11% 35/35 (100%) 14/53 (26%) 2 76% 0 ≥3 71% 4% Yes 83% 0 No 73% 10% Prior therapy 141/160 (88%) 35/143 (24%) Del11q NOTCH1 SF3B1 TP53 57/63 (90%) 7/59 (12%) 114/127 (90%) 42/132 (32%) Del17p MYD88 Yes 71% 7% 56/63 (89%) 13/64 (20%) Mutated No 79% 8% 120/132 (91%) 36/132 (27%) Unmutated Unmutated 77% 0 90/98 (92%) 22/83 (27%) Mutated 74% 15% 32/36 (89%) 12/49 (24%) 0 0 2/3 (67%) 1/3 (33%) 77% 8% 130/139 (93%)