Phase 3 Study of the Bruton’s Tyrosine Kinase Inhibitor, Ibrutinib, in Combination with Rituximab versus Placebo in Combination with Rituximab in Patients with TN FL (PERSPECTIVE)

Conference Correspondent - ASCO 2017 - Chronic Lymphocytic Leukemia

Follicular lymphoma (FL) is the most common subtype of indolent non-Hodgkin lymphoma. However, there is a limited number of chemotherapy-free options for patients with treatment-naïve (TN) FL who are older or who have comorbidities. For these patients, single-agent rituximab is considered as a treatment option. A phase 2 study serves as the basis for the randomized, double-blind, placebo-controlled phase 3 PERSPECTIVE (PCYC-1141-CA) trial. The phase 2 study showed that frontline treatment with ibrutinib in combination with rituximab for 4 weekly doses without maintenance resulted in an overall response rate of 85% with a median follow-up of 22 months, and an 18-month progression-free survival (PFS) rate of 87% (Fowler. Blood. 2016). Based on these results, the phase 3 PERSPECTIVE study will be conducted. It will occur in 2 parts, with part 1 examining whether frontline treatment with ibrutinib in combination with rituximab results in prolongation of PFS compared with rituximab alone, and part 2 examining whether continuous treatment with ibrutinib results in prolongation of PFS compared with finite treatment with ibrutinib.

In the ongoing PERSPECTIVE trial, approximately 440 patients with TN FL meeting ≥1 Groupe d’Etude des Lymphomes Folliculaires criteria will be randomized if they are also either aged ≥70 years or are 60 to 69 years of age with ≥1 comorbidities (creatinine clearance 30-59 mL/min or Eastern Cooperative Oncology Group performance status of 2). In part 1, patients will be randomized to receive either ibrutinib or oral placebo once daily. All patients will receive rituximab for 4 weekly doses followed by maintenance therapy. After undergoing at least 2 years of treatment in part 1, patients randomized to ibrutinib who remain on ibrutinib will be rerandomized in part 2 to continue ibrutinib or switch to placebo. The primary end point is PFS in both parts of the study. The study is open for enrollment, with sites planned in the United States, European Union, and Asia Pacific.

Fowler NH, et al. ASCO Abstract TPS7576.

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Last modified: June 8, 2017
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