ArticleCommunications medicine2026
Canakinumab or emavusertib for anemia in lower-risk MDS: results of the CANFIRE and LUCAS phase 2, open-label, multicenter trials.
Article in Communications medicine, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Not yet cited in PubMed.
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The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Phase II, Open-Label, Multicenter Study of Orally Administered CA-4948 for the Treatment of Anemia in Patients With Very Low, Low or Intermediate Risk Myelodysplastic Syndromes (MDS)
A Phase II, Single-Arm, Open-Label Study to Assess the Efficacy and Safety of Canakinumab for the Treatment of Anemia in Patients With IPSS-R Very Low, Low, or Intermediate Risk Myelodysplastic Syndromes or MDS/MPN
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Authors and funding
24 authors.
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Abstract
backgroundDysregulated innate immune signaling promotes inflammatory suppression of hematopoietic stem and progenitor cell function, contributing to ineffective erythropoiesis in myelodysplastic neoplasms (MDS). The phase 2, open-label CANFIRE and LUCAS trials aimed to determine the efficacy and safety of canakinumab or emavusertib, respectively, in patients with lower-risk MDS (LR-MDS) or myelodysplastic/myeloproliferative neoplasms (MDS/MPN).
methodsPatients in CANFIRE were refractory, intolerant to, or ineligible for erythropoiesis-stimulating agent (ESA) treatment and received canakinumab 200 mg subcutaneously every 21 days for up to eight cycles within the first six months of treatment. Patients in LUCAS were either refractory or intolerant to ESAs (cohort A) or ESA-naïve with serum erythropoietin levels >200 U/L (cohort B); all patients received emavusertib 200-300 mg orally twice daily for 21 days in up to four 28-day cycles. The primary endpoint for both trials was hematologic improvement-erythroid per International Working Group 2018 criteria at the end of the planned treatment period. CANFIRE was registered at ClinicalTrials.gov (NCT05237713; registered January 21, 2022). LUCAS was registered in the EU Clinical Trials Register (EudraCT 2020-003986-20; registered March 15, 2021) and at ClinicalTrials.gov (NCT05178342; registered November 2, 2021).
resultsHere we show that of 11 patients enrolled in CANFIRE and 36 patients enrolled in LUCAS, no patients in either trial achieved the primary endpoint. Canakinumab treatment was well-tolerated, with no reported serious adverse events (SAEs) and no patients died in the CANFIRE trial. In the LUCAS trial, 15 patients reported SAEs, and four patients died. CANFIRE and LUCAS were terminated early due to inadequate patient recruitment and after a pre-planned interim futility analysis, respectively.
conclusionsInhibition of IL-1β or IRAK4 signaling with canakinumab or emavusertib did not result in hematologic improvement in patients with LR-MDS.
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Registered trials
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