623. Mantle Cell, Follicular, and Other Indolent B-Cell Lymphoma-Clinical Studies: Follicular Lymphoma, First Line


Safety and Efficacy of Atezolizumab in Combination with Obinutuzumab and Bendamustine in Patients with Previously Untreated Follicular Lymphoma: An Interim Analysis

Anas Younes, MD1, et al.

The authors of the study conclude:

 In this interim analysis of the G-benda-atezo combination, one treatment-related death occurred. Toxicity was otherwise manageable. Preliminary efficacy data show encouraging first-line activity in FL. Results from the final analysis based on 40 pts, including DoR, PFS and EFS, will be presented at the meeting.



A 3-Arm Randomized Phase II Trial with Bendamustine/Rituximab Therapy in Untreated High Risk (HR) Follicular Lymphoma (FL): Bortezomib Induction or Novel IMiD® Continuation (BIONIC) Study from the ECOG-ACRIN Cancer Research Group

Andrew M. Evens, et al.

The authors of the study conclude:

The BIONIC study showed that Tx with standard BR induction followed by MR was safe in HR FL. The addition of V to BR induction enhanced the CR rate, but did not translate into improved PFS. Additionally, Len continuation Tx as prescribed in this study was associated with increased toxicity vs MR, while yielding similar PFS and OS vs BR-R treated pts. Based upon these results, neither V added to BR induction nor Len added to MR following BR induction can be recommended in FL. Quality of life analyses as well as detailed imaging and correlative biomarker studies are underway.



Four Versus Two Years of Rituximab Maintenance (R-maintenance) Following Bendamustine Plus Rituximab (B-R): Initial Results of a Prospective, Randomized Multicenter Phase 3 Study in First-Line Follicular Lymphoma (the StiL NHL7-2008 MAINTAIN study)

Mathias J Rummel, et al.

The authors of the study conclude:

Results at the time of this analysis appear to favor 4-years over 2-years of R-maintenance and 2-years over observation compared to a historical control. Further analysis including the updated dataset will be presented at the ASH meeting and should provide more definitive evidence regarding the benefit of prolonged R-maintenance.



Assessment of Maintenance Rituximab after First-Line Bendamustine-Rituximab in Patients with Follicular Lymphoma: An Analysis from the BRIGHT Trial

Brad S. Kahl, et al.

The authors of the study conclude:

 In this retrospective analysis of FL patients treated with BR induction therapy on the BRIGHT study, maintenance R significantly improved PFS with a trend towards improvement in OS, despite the fact that patients with CR were less likely to receive maintenance R. Maintenance R also showed a tendency towards improved outcomes after R-CHOP/R-CVP, consistent with data from randomized clinical trials (RCTs). Given that the application of maintenance R was based on investigator discretion, it is possible that the observed effect was due to confounding variables. However, the overall improvement in PFS in the maintenance R patients appears to be at least as great following BR as following R-CHOP/R-CVP and supports the notion of testing maintenance R after BR therapy in RCTs.



Randomized Phase 2 Trial of Ofatumumab and Bendamustine Versus Ofatumumab, Bendamustine, and Bortezomib Induction and Maintenance Therapy in Patients (pts) with Previously Untreated High Risk Follicular Lymphoma (FL): Results from CALGB 50904 (Alliance)

Kristie A. Blum, et al.

The authors of the study conclude:

In this multicenter randomized phase 2 trial, the OR, CR, and PFS with ofatumumab and bendamustine and with ofatumumab, bendamustine, and bortezomib are similar in pts with previously untreated high risk FL, with no significant difference with intensification of therapy with bortezomib. Although grade 3-4 toxicities are similar, more pts treated with bortezomib required dose modifications and early discontinuation. While not the primary endpoint of this trial, the addition of ofatumumab to bendamustine appears to improve CR when compared to historical data with R-bendamustine in untreated FL. However, 3-year PFS rates are similar to historical data and a randomized study would be required to determine if ofatumumab improves PFS as recently observed with obinutuzumab. Support: U10CA180821, U10CA180882. ClinicalTrials.gov Identifier: NCT01286272


Long Term Follow-up of the PRIMA Study: Half of Patients Receiving Rituximab Maintenance Remain Progression Free at 10 Years

Gilles Andre Salles, et al.

The authors of the study conclude:

In summary, PRIMA study long term follow-up demonstrates that R-maintenance after induction immunochemotherapy provides a significant long term PFS benefit over observation. Despite the lack of OS benefit, it is noteworthy that more than half of the patients in the R arm remain free of disease progression and have not required new anti-lymphoma treatment beyond 10 years. With the prolonged life-expectancy of patients with follicular lymphoma, it is important to consider long term treatment-related toxicities and the risk of secondary malignancies related to repeated therapeutic interventions. Obtaining truly durable response with 1stline induction followed by R-maintenance remains an appealing treatment strategy for these patients.