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Omvoh ® ▼ (mirikizumab)
This information is intended for UK registered healthcare professionals only as a scientific exchange in response to your search for information. For current prescribing information for all Lilly products, including Summaries of Product Characteristics, Patient Information Leaflets and Instructions for Use, please visit: www.medicines.org.uk (England, Scotland, Wales) or www.emcmedicines.com/en-GB/northernireland/ (Northern Ireland).
Can patients with a history of cancer receive Omvoh® (mirikizumab)?
The use of mirikizumab in patients with a history of cancer of the GI tract has not been evaluated as these patients were excluded from the mirikizumab clinical trial program. Additional exclusion criteria regarding malignancies are provided below.
Exclusion criteria related to malignancy in the phase 3 studies of mirikizumab for the treatment of ulcerative colitis
Adenoma, Dysplasia, and Gastrointestinal Cancer
Patients with any history or current evidence of cancer of the gastrointestinal tract were excluded from the phase 3 studies of mirikizumab for the treatment of moderately to severely active ulcerative colitis.1
Patients with any current sporadic adenoma without dysplasia (adenomatous polyps occurring proximal to known areas of colitis) that has not been removed were excluded from the LUCENT clinical trial program. Once completely removed, the patients were eligible for study participation.1
Patients with dysplasia occurring in flat mucosa, sporadic adenomas containing dysplasia, or dysplasia-associated lesions or masses (DALMs) were excluded from the LUCENT clinical trial program if they had any history or current evidence of
- high-grade dysplasia
- dysplasia occurring in the flat mucosa, including low-grade dysplasia, high-grade dysplasia, or histopathology reports that were indefinite for dysplasia, or
- a nonadenoma-like DALM, with or without evidence of dysplasia.1
Patients with any current sporadic adenoma containing dysplasia or any current adenoma-like DALM that has not been removed were excluded from the LUCENT clinical trial program. Once completely removed, the patients were eligible for study participation.1
In the phase 3 study of mirikizumab for the treatment of moderately-to-severely active ulcerative colitis, LUCENT-1, patients were excluded from the study if they had lymphoma, leukemia, or any malignancy within the past 10 years other than
- basal cell or squamous epithelial carcinoma of the skin that had been adequately treated with no evidence of metastatic disease for 1 year, or
- cervical carcinoma in situ that had been adequately treated with no evidence of recurrence within the 3 years prior to baseline.1
Patients were excluded from participating in the mirikizumab maintenance study, LUCENT-2, if they
- had evidence of colonic dysplasia (including dysplasia in flat mucosa or DALM) after completion of the induction study, LUCENT-1,
- were diagnosed with cancer of the gastrointestinal tract during the LUCENT-1 study, or
- had current adenomatous polyps that had not been removed (patients were eligible for study participation if adenomatous polyps were removed and the histology report confirmed there was no dysplasia or malignancy present).1
1D'Haens G, Dubinsky M, Kobayashi T, et al. Mirikizumab as induction and maintenance therapy for ulcerative colitis. N Engl J Med. Published online June 29, 2023. https://doi.org/10.1056/NEJMoa2207940
▼ This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions.
Date of Last Review: 30 May 2023