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• W2951033984 abstract "Introduction: Relapse within 2 years of initial chemoimmunotherapy (ie, POD24) in follicular lymphoma (FL) patients has been associated with less favorable prognosis and survival (Casulo et al. Blood. 2019). The objective of this analysis was to examine the potential impact of POD24 in FL patients receiving lenalidomide/rituximab (R2) vs rituximab/placebo (R/placebo) from the phase III AUGMENT study. Methods: Patients with FL grade 1-3a were relapsed/refractory (R/R) after ≥ 1 prior systemic therapy, but were not refractory to rituximab. Treatment arms included R2 (lenalidomide PO 20 mg/day [d], d1-21/28 X12 cycles plus rituximab IV 375 mg/m2given cycle 1, d1, 8, 15, 22 and d1, cycles 2-5) and R/placebo (treated on the same schedule). Progression-free survival (PFS) was the primary endpoint, evaluated by 2007 IWG (without PET). For the AUGMENT study, POD24 was defined post-hoc as progression or relapse within 2 years of initial antilymphoma treatment, which included immuno- and/or chemotherapy. Results: As of 22June2018, 295 FL grade 1-3a patients had been randomized 1:1 to R2 (n=147) and R/placebo (n=148). Median age was 62 years (range, 26-88), 74% of patients had Ann Arbor stage III/IV disease, 34% high FLIPI score, 84% had received prior rituximab, and 53% prior antilymphoma treatment within 2 years of enrollment. Of these FL patients, 56 (38%) R2 and 57 (39%) R/placebo patients were identified as POD24 (ie, relapsing/progressing within 2 years of initial treatment). For all FL patients and subgroups based on POD24 status, median PFS was improved in the R2 vs R/placebo arm (Table). For patients with POD24, HR was 0.41 (95% CI, 0.24-0.68) and for patients with no POD24, HR was 0.43 (95% CI, 0.28-0.65), both groups favoring the R2 arm. Best overall response rates (ORR) and complete responses (CR) were similar within each arm in all FL patients and with or without POD24 (Table). Treatment with R2 (vs R/placebo) reduced the risk of relapse/progression by 59% in patients with POD24, and improved both ORR and CR. Similar outcomes were observed for patients who relapsed within 2 years from diagnosis (data not shown). Conclusions: R2 demonstrated superior efficacy over R/placebo in patients with FL grade 1-3a, including those with POD24, patients who have historically been associated with worse outcomes. 39.4 (23.1-NR) 30.4 (16.8-NR) 39.4 (22.9-NR) 13.9 (11.2-16.0) 13.8 (6.7-16.9) 13.9 (11.2-16.6) Keywords: follicular lymphoma (FL); lenalidomide; rituximab. Disclosures: Leonard, J: Consultant Advisory Role: Celgene, Biotest, Sunesis Pharmaceuticals, Bristol-Myers Squibb, Gilead Sciences, Epizyme, Pfizer, Bayer, Genentech/Roche, ADC Therapeutics, MEI Pharma, AstraZeneca, Novartis, Merck, Sutter Medical Group, Morphosys, Beigene, Nordic Nanovector, Bristol-Myers Squibb, United Therapeutics, Karyopharm Therapeutics, Sand; Research Funding: (all institutional): Celgene, Alliance for Clinical Trials in Oncology, Takeda, Pfizer, National Cancer Institute; Other Remuneration: Travel, Accommodation, Expenses: BeiGene. Trneny, M: Consultant Advisory Role: Takeda, BMS, Incyte, Abbvie, Amgen, Roche, Gilead, Janssen, Celgene, MorphoSys; Honoraria: Janssen, Gilead, Takesa, BMS, Amgen, Abbvie, Roche, MorphoSys, Incyte; Other Remuneration: Travel & Expenses: Gilead, Takeda, BMS, Roche, Janssen, Abbvie. Izutsu, K: Consultant Advisory Role: Eisai, MSD, Takeda, Ono, AstraZeneca, Abbvie, Bayer, Novartis, Chugai, Daiichi Sankyo, Otsuka; Honoraria: Kyowa Hakko Kirin, Eisai, MSD, Takeda, Janssen, Dainippon Sumitomo, Mundipharma, Nihon Mediphysics, Abbvie, Chugai, Zenyaku, Bristol Myers Squib, Astellas; Research Funding: HUYA bioscience, MSD, Astellas Amgen, AstraZeneca, Abbvie, Eisai, Ono, Sanofi, ARIAD, Symbio, Zenyaku, Celgene, Solaisia, Takeda, Daiichi Sankyo, Chugai, Novarsis, Bayer, Pfizer. Fowler, N: Consultant Advisory Role: Roche/Genentech, TG Therapeutics, Verastem, Bayer, Celgene, Novartis; Research Funding: Roche, Celgene, Gilead Sciences, TG Therapeutics, Novartis, Abbvie, BeiGene. Nowakowski, G: Consultant Advisory Role: (author's institution for all): Celgene, Morphosys, Genentech; Research Funding: (author's institution for all) Celgene, NanoString Techonologies, MorphoSys. Pinto, A: Consultant Advisory Role: Servier, Roche, MDS Pharma, BMS; Honoraria: Roche, MDS Pharma, Celgene, Servier, BMS; Other Remuneration: Speakers' Bureau: Roche; Patents, Royalties or Intellectual Property: EDO-Mundipharma; Travel: Roche, Takeda. Scheinberg, P: Consultant Advisory Role: Novartis, Abbvie, Alexion Pharmaceuticals, Janssen, Celgene; Honoraria: Novartis; Other Remuneration: Speakers' Bureau: Novartis, Pfizer. Flinn, I: Consultant Advisory Role: Abbvie, Seattle Genetics, TG Therapeutics, Verastem; Research Funding: (All institutional): Acerta Pharma, Agios, Calithera Biosciences, Celgene, Constellation Pharmaceuticals, Genentech, Gilead Sciences, Incyte, Infinity Pharmaceuticals, Janssen, Karyopharm Therapeutics, Kite Pharma, Novartis, Pharmacyclics, Portola Pharmaceuticals, Roche, TG Therapeutics, Trillium Therapeutics, Abbvie, ArQule, BeiGene, Curis, FORMA Therapeutics, Forty Seven, Merck, Pfizer, Takeda, Teva, Verastem, Gilead Sciences, Astra Zeneca (AZ), Juno Therapeutics, Unum Therapeutics, MorphoSys AG, Abbvie. Czuczman, M: Employment Leadership Position: Celgene; Stock Ownership: Celgene. Kalambakas, S: Employment Leadership Position: Celgene; Stock Ownership: Celgene, Novartis. Fustier, P: Employment Leadership Position: Celgene; Stock Ownership: Celgene. Wu, C: Employment Leadership Position: Celgene; Stock Ownership: Celgene. Gribben, J: Consultant Advisory Role: Abbvie, Acerta Pharma/Astra Zeneca, Celgene, Janssen; Honoraria: Abbvie, Acerta Pharma/Astra Zeneca, Celgene, Janssen, Gilead Sciences, Roche/Genentech, TG Therapeutics; Research Funding: Acerta Pharma/Astra Zeneca, Janssen, Celgene." @default.
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• W2951033984 date "2019-06-01" @default.
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• W2951033984 title "AUGMENT PHASE III STUDY: LENALIDOMIDE/RITUXIMAB (R² ) IMPROVED EFFICACY OVER RITUXIMAB/PLACEBO IN RELAPSED/REFRACTORY FOLLICULAR PATIENTS IRRESPECTIVE OF POD24 STATUS" @default.
• W2951033984 doi "https://doi.org/10.1002/hon.75_2629" @default.
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