The primary endpoint in both trials is PFS, with secondary endpoints of OS and safety.The E1912 investigators noted in their abstract that the findings have immediate practice-changing implications, “establishing ibrutinib-based therapy as the most efficacious first-line therapy for patients with CLL.”This trial, as well as the Alliance and iLLUMI- NATE trials, was designed to span the entire population of patients with CLL and broadly compare chemoimmunotherapy with targeted therapy, said Woyach.These agents are not perfect for all patients, Woyach added. The meeting will provide an invaluable educational experience and the opportunity to review thousands of scientific abstracts highlighting updates in the hottest topics in hematology. Presenters at the recent meeting of the American Society of Hematology (ASH; December 1–4, 2018, in San Diego, CA) reported the latest research in hematology. “This was a big year at ASH for targeted therapy,” said Jennifer A. Woyach, MD, associate professor at The Ohio State University Comprehensive Cancer Center in Columbus, who presented her own research at the meeting. It also tells us, for patients with a higher-risk CLL, that chemoimmunotherapy as frontline therapy should not be the go-to.”Investigators noted that clinical data show pembrolizumab is ineffective as monotherapy for relapsed or refractory CLL and has a 90% failure rate for Richter transformation, with a median OS of 2 months.

“Most patients with previously untreated CLL should not see chemotherapy as part of their treatment plan. The study had 2 CRs in patients with Richter transformation. These are the Alliance trial A041702 (NCT03737981) and the ECOG-ACRIN trial EA9161 (NCT03701282). In 2019, ASH held its second annual ASH-a-Palooza at the 61st ASH Annual Meeting in Orlando, FL. David Green, MD, PhD. They said data from this study support continued development of single-dose liso-cel in the treatment of CLL.Newer products are being developed and modifications are being made to CAR T-cell therapies and adjuvants such as ibrutinib. The immune system of someone with CLL is so suppressed that adding ibrutinib, which modulates the immune system in a way to make it function more normally, can improve its function with CAR T cells, she said.“That was really unexpected to see a survival advantage, especially so early on,” said Woyach. 60th ASH Annual Meeting & Exposition Meeting Dates: December 1-4, 2018 Exhibit Dates: December 1-3, 2018 San Diego Convention Center ~ San Diego, CA Company standard electric, and a company will be available Friday, door, standard electric, and a company identification sign. They hypothesized that anti—PD-1 therapy combinations will be successful in treating CLL and Richter transformation, especially in patients who are relapsed/refractory to ibrutinib, and suggested that PD-1 and PI3K blockade would be synergistic.The minimal residual disease (MRD) analysis for the intention-to-treat population showed that 35% of patients had undetectable MRD on ibrutinib plus obinutuzumab in bone marrow and/or peripheral blood testing versus 25% of those in the chlorambucil plus obinutuzumab arm. That included rates of grade ≥3 cytokine release syndrome (CRS) compared with a similar group of patients receiving only JCAR014.Investigators suggested that the data were promising, showing that patients with remissions are living longer with this treatment. Patients did not have higher immune-mediated toxicities than would be expected with pembrolizumab or umbralisib alone. It is thought to be the first PD-1, anti-CD20, and PI3Kδ inhibitor combination for this patient population.“[Results from] this study do not show that ibrutinib plus obinutuzumab is better than ibrutinib alone, but [the data] are promising. NHLBI-supported research will be presented at more than 100 sessions. “We have not seen PD-1 inhibitors to be very effective prior to this in CLL.” Although the study had only a few patients with Richter transformation, she said it was exciting to see some success.This was one of 3 studies presented at ASH with this drug combination, said Woyach; the other studies were from The University of Texas MD Anderson Cancer Center and The Ohio State University.As for take-home lessons from ASH, Woyach reiterated the importance of targeted therapies.

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