Chen R et al. Proc ASH 2015;Abstract 518.

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Chen R et al. Proc ASH 2015;Abstract 518. Pre-Transplant R-Bendamustine Induces High Rates of Minimal Residual Disease in MCL Patients: Updated Results of S1106: US Intergroup Study of a Randomized Phase II Trial of R-HCVAD Vs. R-Bendamustine Followed By Autologous Stem Cell Transplants for Patients with Mantle Cell Lymphoma Chen R et al. Proc ASH 2015;Abstract 518.

S1106 Trial: R-hyper-CVAD (RH) versus Bendamustine/Rituximab (BR) Followed by Autologous Stem Cell Transplant (ASCT) Phase II randomized study of RH versus BR N = 52 evaluable out of a planned 160 patients aged 18 to 65 years with untreated mantle-cell lymphoma (MCL) eligible for ASCT Primary endpoint: 2-year progression-free survival (PFS) Endpoint BR (n = 35) RH (n = 17) Two-year PFS 81% 82% Two-year overall survival 87% 88% Overall response rate 83% 94% Complete response rate 40% 35% Chen R et al. Proc ASH 2015;Abstract 518.

S1106: Conclusions RH is not an ideal platform for future transplant trials in MCL because of stem cell mobilization failures: Only 4 of 17 patients who received RH and 21 of 35 who received BR underwent ASCT. PFS rate at 2 years with BR was 81%, higher than the planned target of 75%. Minimal residual disease (MRD) negativity rate with BR was 89% for all the paired samples tested. All patients with MRD-negative status remain in remission, with some not having undergone ASCT. Low complete response rate with BR could be due to lack of mandatory PET. Premature closure of the study limited the sample size and the precision of PFS estimates and MRD assessment. However, this analysis suggests that BR can effect deep remissions and could be a platform for future trials in MCL. Chen R et al. Proc ASH 2015;Abstract 518.

Investigator Commentary: Updated Results of the Phase II S1106 Trial of RH versus BR followed by ASCT in MCL Rob Chen and colleagues presented data from the S1106 Intergroup Phase II trial evaluating RH versus BR followed by ASCT for patients with MCL. Data were reported on MRD status, for which negative status has been previously demonstrated to predict improved long-term outcomes, and 2-year PFS and overall survival. A total of 53 patients were accrued out of the planned 160 because the study arm alternating RH with R-MTX/Ara-C was closed early owing to stem cell collection failures. Overall, the ORR was 94% with RH and 83% with BR and the complete response rates were generally comparable at 35% and 40%. Interestingly, the complete response rate for the RH arm was actually lower than what has been typically observed in the past with this regimen. This may be because some of the patients came off treatment earlier than planned owing to potential tolerability issues in comparison to the BR approach. So the investigators concluded that the complete response rates for both arms were about equal. Continued

Investigator Commentary: Updated Results of the Phase II S1106 Trial of RH versus BR followed by ASCT in MCL Also, the 2-year PFS and overall survival overlapped for both treatment arms at 81% and 87%, respectively. BR achieved a high MRD negativity rate of 89%, and all patients with negative status remain without disease relapse independent of whether they underwent ASCT. These data support the transition of BR to the front-line setting for MCL management as a platform for therapy given its high effectiveness, including high MRD negativity rates and overall good tolerability. Interview with Michelle A Fanale, MD, February 18, 2016