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Clinical Trial
. 2025 Apr 8;9(7):1712-1719.
doi: 10.1182/bloodadvances.2024014840.

Six-month rituximab-lenalidomide regimen in advanced untreated follicular lymphoma: SAKK 35/10 trial 10-year update

Eva Kimby  1 , Sämi Schär  2 , Maria Cristina Pirosa  3 , Anna Vanazzi  4 , Ulrich M Mey  5 , Daniel Rauch  6 , Björn E Wahlin  7 , Felicitas Hitz  8 , Micaela Hernberg  9 , Ann-Sofie Johansson  10 , Peter de Nully Brown  11 , Hans Hagberg  12 , Andrés José María Ferreri  13 , Fatime Krasniqi  14 , Michèle Voegeli  15 , Urban Novak  16 , Thilo Zander  17 , Hanne Bersvendsen  18 , Christoph Mamot  19 , Walter Mingrone  20 , Anastasios Stathis  3   21 , Stefan Dirnhofer  22 , Stefanie Hayoz  2 , Bjørn Østenstad  23 , Emanuele Zucca  3   21   24
Affiliations
Clinical Trial

Six-month rituximab-lenalidomide regimen in advanced untreated follicular lymphoma: SAKK 35/10 trial 10-year update

Eva Kimby et al. Blood Adv. .

Abstract

The Swiss Group for Clinical Cancer Research (SAKK) and the Nordic Lymphoma Group conducted the SAKK 35/10 randomized phase 2 trial to compare rituximab (R) alone vs R plus lenalidomide (L) as initial treatment for follicular lymphoma (FL). Patients with grade 1 to 3A FL, requiring systemic therapy, were randomized to either R (n = 77; 375 mg/m2 IV × 1, weeks 1-4) or rituximab-lenalidomide (RL) (n = 77; R on the same schedule and L at 15 mg daily continuously). Responders (evaluated at 10 weeks) repeated R during weeks 12 to 15 with or without L (for a total of 18 weeks). Both arms had 47% of patients with a poor risk score on the FL International Prognostic Index. The primary end point, complete response (CR)/CR unconfirmed rates at 6 months, was superior with the combination, and after a median follow-up of 9.5 years, this has translated into a longer duration of response (median, not reached vs 3.2 years; hazard ratio [HR], 0.42; 95% confidence interval [CI], 0.21-0.86; P = .014), progression-free survival (9.3 vs 2.3 years; HR, 0.57; 95% CI: 0.37-0.89; P = .0128), and time to next treatment (median, not reached vs 2.1 years; HR, 0.43; 95% CI, 0.27-0.67; P < .001). Over 60% of RL responders remained in first CR at 10 years. Overall survival was similar in both arms (77% vs 78% at 10 years; P = .881). Toxicity was more common with RL but manageable. The SAKK 35/10 trial's long-term results confirmed a durable benefit of a short-term chemotherapy-free first-line RL regimen in symptomatic FL. This trial was registered at www.clinicaltrials.gov as #NCT0137605.

Trial registration: ClinicalTrials.gov NCT00137605 NCT00137605.

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Conflict of interest statement

Conflict-of-interest disclosure: E.K. received advisory board fees from AbbVie, Pfizer, and Pierre Fabre, and provided educational lectures for Janssen, AbbVie, and AstraZeneca. E.Z. received research funding from Celgene, Roche, and Janssen; has served on the advisory board of Celgene, Roche, Mei Pharma, AstraZeneca, and Celltrion Healthcare; received travel grants for meetings from AbbVie and Gilead; and provided expert statements to Gilead, Bristol Myers Squibb, and Merck Sharp & Dohme (MSD). B.E.W. received research funding from Incyte. U.M.M. has served on the advisory board of Roche, Janssen, Bristol Myers Squibb, Amgen, AbbVie, and Gilead; and has received travel grants for meetings from AbbVie, Janssen, Amgen, Gilead, and Bristol Myers Squibb. M.H. has served on the advisory board of MSD, Bristol Myers Squibb, Amgen, Incyte, Sanofi, and Novartis; has given lectures to MSD, Novartis, and Bristol Myers Squibb; and has received travel grants for meetings from Amgen, MSD, Sanofi, Roche, and Novartis. A.J.M.F. has received research funding from Celgene. T.Z. reports consultancy fees from BeiGene Switzerland. P.d.N.B. has served on the advisory board for Roche, AbbVie, and SERB. F.K. received the registration fee for a congress from Roche. The remaining authors declare no competing financial interests.

The current affiliation for D.R. is Inselspital University Cancer Center UCI, Das Tumorzentrum Bern, Bern, Switzerland.

Figures

None
Graphical abstract
Figure 1.
Figure 1.
Kaplan-Meier curves of secondary (time-dependent) end points. (A) PFS. (B) DOR. (C) TTNT. (D) OS. DoR, duration of response.
See this image and copyright information in PMC

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