MAGNIFY PHASE IIIB INTERIM ANALYSIS: FIRST REPORT OF INDUCTION R2 FOLLOWED BY MAINTENANCE IN PATIENTS WITH RELAPSED/REFRACTORY MANTLE CELL LYMPHOMA

Introduction: The combination of lenalidomide + rituximab (R2) has demonstrated efficacy comparable to standard chemoimmunotherapy regimens in the frontline setting, and improved efficacy compared to rituximab monotherapy in the relapsed/refractory (R/R) setting among patients with indolent B-cell NHL. The multicenter, non-registrational phase IIIb MAGNIFY trial enrolled patients with R/R follicular, marginal zone, and mantle cell lymphomas (NCT01996865). This evaluation focuses on MCL patients, an aggressive though uncommon form of NHL, to determine the optimal duration of induction and maintenance therapy. Methods: R2 treatment includes lenalidomide 20 mg/d, d1-21/28 + rituximab 375 mg/m2/wk cycle 1 and q8wk cycles 3+ for 12 cycles of induction followed by 1:1 randomization to continued R2 vs rituximab maintenance in patients with stable disease or better. Rituximab refractory was defined as a best response of progressive/stable disease to rituximab-containing treatment or partial/complete response for < 6 mo following the last dose of rituximab. These analyses evaluate the interim primary endpoint of ORR by 1999 IWG criteria for induction R2 in efficacy-evaluable MCL patients receiving ≥ 1 treatment and with baseline/post-baseline assessments, including those who were rituximab refractory. Results: Seventy MCL patients were enrolled with a median age of 69.5 y (range, 51-88), 90% stage III/IV disease, 43% bulky disease, and 100% had received prior rituximab-containing therapy. At a median follow-up of 14.6 mo, efficacy-evaluable MCL patients showed a 54% ORR and 38% CR (Table). Median TTR was 2.9 mo, median DOR was 27.4 mo, and median PFS was 10.6 mo. Seventeen of 70 patients have been randomized and entered maintenance. The most common all-grade adverse events (AEs; ≥ 20%) were 45% neutropenia, 40% fatigue, 24% constipation, 24% dyspnea, 22% anemia, 21% diarrhea, and 21% nausea. Grade 3/4 neutropenia was 39%; all other grade 3/4 AEs were ≤ 10%. Conclusions: This first report of patients with R/R MCL from the MAGNIFY study showed that R2 therapy is active with a tolerable safety profile, including improving activity among patients considered sensitive to prior rituximab. Keywords: lenalidomide; mantle cell lymphoma (MCL); rituximab. Disclosures: Sharman, J: Employment Leadership Position: US Oncology; Consultant Advisory Role: Pharmacyclics, Celgene, TG Therapeutics, Genentech, Abbvie, Acerta Pharma/Astra Zeneca; Research Funding: (all institutional) Pharmacyclics, Genentech, Celgene, Acerta Pharma, Gilead Sciences, Seattle Genetics, TG Therapeutics, Merck, Takeda; Other Remuneration: Expert Testimony: Gilead Sciences. Coleman, M: Consultant Advisory Role: Medaptive Health; Stock Ownership: Medaptive Health; Research Funding: Medaptive Health; Other Remuneration: Speakers' Bureau: Medaptive Health. Yacoub, A: Consultant Advisory Role: Medadaptive; Other Remuneration: Speakers' Bureau: Medaptive Health. Melear, J: Employment Leadership Position: Medaptive Health. Fanning, S: Consultant Advisory Role: Medaptive Health; Stock Ownership: Medaptive Health; Other Remuneration: Speakers' Bureau: Medaptive Health. Kolibaba, K: Employment Leadership Position: Compass Oncology; Consultant Advisory Role: Gilead Sciences; Honoraria: TG Therapeutics; Research Funding: (all institutional) Acerta, Celgene, Cell Therapeutics, Genentech/Roche, Gilead Sciences, Janssen, Pharmacyclics, Novartis, Seattle Genetics, TG Therapeutics; Other Remuneration: Travel: TG Therapeutics. Lansigan, F: Consultant Advisory Role: Spectrum; Research Funding: Spectrum. Li, J: Employment Leadership Position: Celgene; Stock Ownership: Celgene, Medaptive. Llorente, M: Employment Leadership Position: Celgene; Stock Ownership: Celgene, Medaptive. Rummel, M: Consultant Advisory Role: Medadaptive; Honoraria: Medadaptive; Research Funding: Medadaptive; Other Remuneration: Travel: Medadaptive. Andorsky, D: Consultant Advisory Role: Medadaptive; Research Funding: Medaptive.