Aaron T. Gerds, MD, MS

At a press conference where the ECOG-ACRIN E1912 presentation and related issues were discussed, session moderator Aaron T. Gerds, MD, MS, of the Cleveland Clinic Taussig Cancer Center, was quite enthusiastic about these results.

“I believe these results should change clinical practice. Anecdotally, I see some patients with chronic lymphocytic leukemia (CLL) treated with FCR (fludarabine, cyclophosphamide, and rituximab [Rituxan]) who develop secondary myelodysplastic syndrome, which is a devastating complication. The ibrutinib (Imbruvica)/rituximab combination is not genotoxic; that is, it doesn’t damage the DNA like FCR does. Thus, this is an attractive combination for the first-line treatment of younger patients with CLL,” Dr. Gerds continued.

When asked if he thought the results would trickle down and change practice in the community, he said: “One barrier to changing practice is unfamiliarity with the drugs, but most oncologists are already comfortable with ibrutinib and rituximab. That being said, ibrutinib is given until disease progression, and it is the only drug in the first-line setting given this way. We need to figure out how to give less drug. This has implications for quality of life, cost, and health-care resource utilization. Perhaps ‘hitting patients harder’ with upfront combinations using combinations of drugs like ibrutinib, obinutuzumab (Gazyva), and venetoclax (Venclexta) could achieve a deeper remission and obviate the need for chronic therapy.”

Dr. Gerds said that the combination is being filed for approval as first-line therapy for younger patients with CLL, but other first-line chemotherapy-free options are available, including ibrutinib plus obinutuzumab.

“Ibrutinib/rituximab will be used even if it is not approved. In CLL, we have a number of drugs and combinations that are possible, and this muddies the waters. Cooperative group studies are important, and this phase III cooperative group study [E1912] emboldens people to use these regimens. It is up to clinicians to sift through the weeds to choose one regimen over another,” he said.

“In the past, cooperative groups have not interacted with regulatory bodies or pharmaceutical companies. Over the past several years, it has become more of a partnership, and industry wants to partner with the cooperative groups,” Dr. Gerds added. ■

DISCLOSURE: Dr. Gerds has received research funding from Samus Therapeutics, Imago BioSciences, Genentech, Roche, Celgene, Apexx Oncology, CTI BioPharma, and Incyte and is a consultant for Celgene, Apexx Oncology, CTI BioPharma, and Incyte.