Abstract
We evaluated the triplet regimen obinutuzumab-atezolizumab-lenalidomide (G-atezo-len) for patients with relapsed/refractory (R/R) follicular lymphoma (FL) in an open-label, multicenter phase Ib/II study (BO29562; NCT02631577). An initial 3 + 3 dose‐escalation phase to define the recommended phase II dose of lenalidomide was followed by an expansion phase with G-atezo-len induction and maintenance. At final analysis, 38 patients (lenalidomide 15 mg, n = 4; 20 mg, n = 34) had completed the trial. Complete response rate for the efficacy population (lenalidomide 20 mg, n = 32) at end-of-induction was 71.9% (66.7% in double‐refractory patients [refractory to rituximab and alkylator] [n = 12]; 50.0% in patients with progressive disease within 24 months of first-line therapy [n = 12]). The 36-month progression-free survival rate was 68.4%. All treated patients had ≥1 adverse event (AE; grade 3–5 AE, 32 patients [84%]; serious AE, 18 patients [47%]; AEs leading to discontinuation of any study drug, 11 patients [29%]). There were 2 fatal AEs (1 merkel carcinoma, 1 sarcomatoid carcinoma; both unrelated to any study drug). The G‐atezo-len regimen is effective and tolerable in patients with R/R FL. AEs were consistent with the known safety profile of the individual drugs.
Highlights
Follicular lymphoma (FL) is the most common indolent nonHodgkin’s lymphoma (NHL) in the Western world [1]
Reported adverse events of special interest (AESI) with obinutuzumab included 3 cases of second malignancies. In this phase Ib/II study, the chemotherapy-free triplet regimen G-atezo-len demonstrated marked efficacy and an acceptable and manageable toxicity profile when used as induction and maintenance therapy in patients with R/R FL who had received at least one prior anti-CD20 monoclonal antibody (mAb)-containing immunochemotherapy regimen
The primary endpoint was met: G-atezo-len resulted in a complete response (CR) rate at EOI of 71.9% and a 36-month progression-free survival (PFS) rate of 68.4%
Summary
Follicular lymphoma (FL) is the most common indolent nonHodgkin’s lymphoma (NHL) in the Western world [1]. The vast majority of patients treated for FL usually respond to initial chemoimmunotherapy regimens [2], most will relapse, and experience increasing refractoriness to subsequent lines of therapy [3]. This has led to research into novel treatment regimens such as phosphoinositide 3-kinase inhibitors (PI3K); [4, 5] or those combining an anti-CD20 monoclonal antibody (mAb) and an immunomodulatory agent. In phase II/ III studies in patients with NHL, including those with relapsed/ refractory (R/R) FL, lenalidomide in combination with rituximab (R2 regimen) demonstrated manageable safety and superior efficacy over rituximab alone [12,13,14,15,16]. Chemotherapy-free induction and maintenance treatment with the novel glycoengineered humanized type II anti-CD20 antibody obinutuzumab plus lenalidomide showed favorable activity and tolerable safety in patients with R/R FL in the phase II GALEN study [17, 18]
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