Evidence map›Paper›PMID 41526601›Full record

ArticleInternational journal of clinical oncology2026

Efficacy and safety of subcutaneous mosunetuzumab in combination with lenalidomide and as a monotherapy in Japanese patients with relapsed/refractory follicular lymphoma.

Shinichi Makita, Koji Izutsu, Yuko Mishima, Takahiro Kumode, Junya Kuroda, Nobuhiro Kanemura, Noriko Fukuhara, Kazuyuki Shimada, Chiemi Mori, Atsuko Kawasaki and 2 more

Abstract readClinical Trial, Phase IMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Article in International journal of clinical oncology, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

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0citing papers in PubMed
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1 · What the graph read from it

What it found

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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

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Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

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4 · The record

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5 · Who and what money

Authors and funding

12 authors.

Shinichi MakitaDepartment of Hematology, National Cancer Center Hospital, Tokyo, Japan. smakita@ncc.go.jp.ORCID http://orcid.org/0000-0001-6609-8088
Koji IzutsuDepartment of Hematology, National Cancer Center Hospital, Tokyo, Japan.
Yuko MishimaDepartment of Hematology Oncology, Cancer Institute Hospital, Japanese Foundation for Cancer Research, Tokyo, Japan.
Takahiro KumodeDepartment of Hematology and Rheumatology, Faculty of Medicine, Kindai University, Osaka, Japan.
Junya KurodaDivision of Hematology and Oncology, Department of Medicine, Kyoto Prefectural University of Medicine, Kyoto, Japan.
Nobuhiro KanemuraDepartment of Hematology and Infectious Disease, Gifu University Hospital, Gifu, Japan.
Noriko FukuharaDepartment of Hematology, Tohoku University, Sendai, Japan.
Kazuyuki ShimadaDepartment of Hematology and Oncology, Nagoya University Graduate School of Medicine, Nagoya, Japan.
Chiemi MoriChugai Pharmaceutical Co., Ltd, Tokyo, Japan.
Atsuko KawasakiChugai Pharmaceutical Co., Ltd, Tokyo, Japan.
Takeshi MiyakeChugai Pharmaceutical Co., Ltd, Tokyo, Japan.
Dai MaruyamaDepartment of Hematology Oncology, Cancer Institute Hospital, Japanese Foundation for Cancer Research, Tokyo, Japan.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundJO40295 (jRCT2080223801) evaluated the efficacy and safety of subcutaneous (SC) mosunetuzumab, in combination with lenalidomide and as monotherapy, in Japanese patients with relapsed/refractory (R/R) follicular lymphoma (FL). We report outcomes from the interim analysis of the FLMOON-2 (≥ 1 prior therapy; mosunetuzumab plus lenalidomide) and primary analysis of the FLMOON-3 (≥ 2 prior therapies; mosunetuzumab monotherapy) cohorts.

methodsMosunetuzumab SC was administered with Cycle (C)1 step-up dosing in both cohorts: C1 Day (D)1, 5 mg; C1D8, D15 and C2 onwards, 45 mg. In FLMOON-2, oral lenalidomide was administered from C2 onwards, on D1-21 of each cycle. Treatment was administered up to C12 in FLMOON-2 and C8 or C17 in FLMOON-3. The primary endpoint was independent review facility-assessed complete response (CR) rate.

resultsAt the clinical cut-off date (FLMOON-2: April 4, 2024; FLMOON-3: March 4, 2024), in the efficacy-evaluable populations, CR rate was 92.3% in FLMOON-2 (n = 13) and 100% in FLMOON-3 (n = 5). In the safety-evaluable populations (FLMOON-2, n = 17; FLMOON-3, n = 5), Grade 3/4 adverse events (AEs) occurred in 64.7% of patients in FLMOON-2 and 20.0% in FLMOON-3. No Grade 5 AEs or AEs leading to treatment discontinuation occurred in either cohort. Cytokine release syndrome was reported in 47.1% of patients in FLMOON-2 and 20.0% in FLMOON-3. Serum mosunetuzumab concentration peaked with the third dose of mosunetuzumab in C1 and reached a steady state with repeated dosing.

conclusionMosunetuzumab SC, in combination with lenalidomide and as monotherapy, demonstrated promising efficacy with a manageable safety profile in Japanese patients with R/R FL.

Indexed as

Antibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsLenalidomideLymphoma, FollicularNeoplasm Recurrence, LocalAdultAgedAged, 80 and overFemaleHumansInjections, SubcutaneousJapanMaleMiddle AgedTreatment OutcomeAntibodies, Monoclonal, HumanizedLenalidomideBispecific antibodiesFollicular lymphomaJapanLenalidomideMosunetuzumabSubcutaneous

Identifiers

PMID41526601
PMCPMC12932324

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.