Akkad Neha, Feng Lei, Westin Jason R, Hagemeister Fredrick B, Lee Hun Ju, Fayad Luis, Ahmed Sairah, Nair Ranjit, Rodriguez Maria Alma, Strati Paolo, Chihara Dai, Flowers Christopher R, Claret Linda, Ibanez Karina, Wang Michael, Fowler Nathan H, Henderson Jared, Davis R Eric, Neelapu Sattva S, Green Michael, Nastoupil Loretta J
Division of Cancer Medicine, Hematology/Medical Oncology Fellowship Program, The University of Texas MD Anderson Cancer Center, Houston, TX.
Department of Biostatistics, The University of Texas MD Anderson Cancer Center, Houston, TX.
Blood Adv. 2025 Sep 9;9(17):4396-4404. doi: 10.1182/bloodadvances.2025016483.
Follicular lymphoma (FL) has a clinical course that is often characterized by high response rates to first-line therapy, followed by multiple relapses over a prolonged natural history. Currently, there are multiple possible approaches to frontline therapy for untreated advanced-stage FL, but there is an ongoing debate around what is the preferred approach. Based on the benefits seen with combining lenalidomide, an immunomodulatory agent, with rituximab, an anti-CD20 antibody, we aimed to evaluate the safety and efficacy of lenalidomide in combination with obinuzutumab, an anti-CD20 antibody with enhanced antibody-dependent cellular cytotoxicity. The eligibility criteria included a diagnosis of FL, grade 1 to 3a, stage II to IV, Eastern Cooperative Oncology Group performance status ≤ 2, adequate organ function, and high tumor burden according to the Groupe d'Étude des Lymphomes Folliculaires criteria. Participants received 6 cycles of induction with the combination, followed by 24 cycles of maintenance. Among 90 patients, the primary end point, 2-year progression-free survival (PFS), was 93.3% (95% confidence interval [CI], 88.2-98.6), and the median PFS was not reached with a median follow-up of 70.7 months. The complete response rate at 30 months was 89.7% (95% CI, 81.3-95.2). The most common adverse events (AEs) of any grade were diarrhea (61.1%), maculopapular rash (53.3%), and fatigue (52.2%). The most common AEs ≥ grade 3 were neutropenia (18.9%), maculopapular rash (11.1%), and pneumonia (6.7%). In this single-center trial, these findings indicate that, for patients with previously untreated, high tumor burden FL, obinutuzumab and lenalidomide led to robust and durable responses with a favorable 2-year PFS and manageable safety profile. This trial was registered at www.clinicaltrials.gov as #NCT02871219.
滤泡性淋巴瘤（FL）的临床病程通常表现为对一线治疗的高缓解率，随后在漫长的自然病程中多次复发。目前，对于未经治疗的晚期FL的一线治疗有多种可能的方法，但对于哪种是首选方法仍存在争议。基于免疫调节剂来那度胺与抗CD20抗体利妥昔单抗联合使用所显示的益处，我们旨在评估来那度胺与奥滨尤妥珠单抗联合使用的安全性和有效性，奥滨尤妥珠单抗是一种具有增强抗体依赖性细胞毒性的抗CD20抗体。入选标准包括根据滤泡性淋巴瘤研究组标准诊断为1至3a级、II至IV期的FL，东部肿瘤协作组体能状态≤2，器官功能良好，以及高肿瘤负荷。参与者接受6个周期的联合诱导治疗，随后进行24个周期的维持治疗。在90例患者中，主要终点2年无进展生存期（PFS）为93.3%（95%置信区间[CI]，88.2 - 98.6），中位随访70.7个月时未达到中位PFS。30个月时的完全缓解率为89.7%（95% CI，81.3 - 95.2）。任何级别的最常见不良事件（AE）为腹泻（61.1%）、斑丘疹（53.3%）和疲劳（52.2%）。≥3级的最常见AE为中性粒细胞减少（18.9%）、斑丘疹（11.1%）和肺炎（6.7%）。在这项单中心试验中，这些结果表明，对于先前未经治疗、高肿瘤负荷的FL患者，奥滨尤妥珠单抗和来那度胺导致了强劲且持久的缓解，2年PFS良好且安全性可控。该试验在www.clinicaltrials.gov上注册为#NCT02871219。
