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Novel therapy combination effective in large cell lymphoma
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ORLANDO – Combining all novel drugs – rituximab, lenalidomide and ibrutinib – to treat diffuse large B-cell lymphoma proved more effective than standard chemotherapy and combinations thereof, according to a poster presenter at the ASH Annual Meeting and Exposition.
“The community treating patients with large cell lymphoma has learned lessons from large phase 3 trials that I call the ‘R-CHOP plus X’ trials that in large cell lymphoma adding in drugs like ibrutinib or lenalidomide don’t help very much. There have been several negative clinical trials using the ‘R-CHOP plus novel drug’ vs. ‘R-CHOP plus placebo.' In our study we didn't do that," Jason Westin, MD, MS, FACP, associate professor of medicine at The University of Texas MD Anderson Cancer Center told HemOnc Today.
"We used novel-novel combinations, not just chemo plus one drug but novel drugs with each other," he continued. "That allows for the synergy that we thought we would see and allows these new drugs to reach their full potential. This is not another R-CHOP plus something new. This is a different approach to get that synergy.”
In the Smart Start trial, Westin and colleagues conducted an open-label, single-arm phase 2 study in newly diagnosed non-GCB DLBCL (n = 58) using rituximab (Rituxan, Genentech), lenalidomide (Revlimid, Celgene) and ibrutinib (Imbruvica; Pharmacyclics, Janssen) – collectively known as RLI – alone via a two-cycle lead-in and followed by RLI with standard chemotherapy for six cycles.
The overall response rate for the RLI alone cycles was 86% and complete response was 36% and patients achieving partial response showed an 81% median tumor reduction from baseline. After total treatment, the overall response was 100% with 95% producing a complete response. None of the 5% who had partial response relapsed within the follow-up period of 19.3 months. Westin and colleagues estimate 1-year PFS is 92.5% and OS is 96.5%.
“Prior to a starting chemotherapy, we had a response rate of 86%. Using this synergy at 1 year, we have a PFS of 93% in a very high-risk group of patients,” Westin said. “These results appear to be significantly better than what we would expect but it’s not a randomized study. I wouldn’t advise everybody start doing this off protocol, but future studies are absolutely warranted.” – by Katrina Altersitz
Reference:
Westin JR, et al. Abstract 1581. Presented at: ASH Annual Meeting and Exposition; Dec. 7-10, 2019; Orlando, Florida.
Disclosures: Westin reports financial relationships with 47 Inc, Curis, Celgene, Janssen, Novartis, Genentech, Juno, Kite, MorphoSys and Unum.