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Omvoh ® ▼ (mirikizumab)
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What is the incidence of malignancies with Omvoh® (mirikizumab) in both ulcerative colitis and Crohn's Disease?
In phase 2 and 3 studies including 4802 patients with 11,003.1 patient years (PY) of exposure to mirikizumab, 64 patients (1.3%) reported a malignancy (incidence rate per 100 PY, 0.6; 95% CI, 0.4-0.7).
Content Overview
Incidence of Malignancies From the Mirikizumab Clinical Trials For All Evaluated Indications
Across all phase 2 and 3 studies involving 4802 patients with 11,003.1 patient years (PY) of exposure to mirikizumab, 64 patients (1.3%) experienced at least one treatment-emergent malignancy (incidence rate per 100 PY, 0.6; 95% CI, 0.4-0.7).1
The integrated safety dataset includes all patients from phase 2 and 3 studies of mirikizumab for psoriasis, ulcerative colitis, and Crohn's disease who received at least one dose. This includes all treatment periods and posttreatment follow-up through October 4, 2023. Over half of the patients (58.6%) received mirikizumab for at least 2 years.1
Treatment-Emergent Malignancies in the Phase 3 Crohn's Disease Clinical Trial: VIVID-1
During the 52-week VIVID-1 study, malignancies were reported in
- 0.3% of patients who received mirikizumab
- 0.5% of patients who received placebo, and
- 0 patients who received ustekinumab (Frequency of Malignancies in the VIVID-1 Clinical Trial,).2
Eventb |
Mirikizumab |
Ustekinumab |
Placebo |
Malignancies |
2 (0.3) [0.3] |
0 (0.0) [0.0] |
1 (0.5) [0.8] |
NMSC |
1c (0.2) [0.2] |
0 (0.0) [0.0] |
1 (0.5) [0.8] |
Malignancies excluding NMSC |
1d (0.2) [0.2] |
0 (0.0) [0.0] |
0 (0.0) [0.0] |
Abbreviations: EAIR = exposure-adjusted incidence rates; NMSC = nonmelanoma skin cancer; PYE = patient years of exposure.
aIncludes all patients who received at least one dose of study drug.
bData presented as n (%) [EAIR].
cBasal cell carcinoma.
dBreast cancer.
Treatment-Emergent Malignancies in the Phase 3 Ulcerative Colitis Clinical Trials: LUCENT-1, LUCENT-2, and LUCENT-3
During the 12-week induction phase (LUCENT-1), malignancies were reported in
- 0.2% of patients who received mirikizumab, and
- 0 patients who received placebo.3
In the 40-week maintenance phase (LUCENT-2), malignancies were reported in
- 0.3% of patients rerandomized to mirikizumab, and
- 0.5% of patients rerandomized to placebo.3
Among patients receiving extended induction treatment with mirikizumab, 1.3% reported malignancies.3
In patients receiving open-label maintenance dosing, 0.6% reported malignancies.3
Through the first 100 weeks of LUCENT-3 (week 52 to week 152 of continuous mirikizumab treatment), 1 malignancy (0.3%) was reported.4
Frequency of Malignancies in the LUCENT Clinical Trial Program provides additional information on the malignancies in the clinical trial program.
Event |
Treatment Group |
|
LUCENT-1 MIRI Induction |
MIRI 300 mg IV Q4W (n=958) |
PBO IV Q4W (n=321) |
LUCENT-1 Week 12 |
||
All malignancies, n (%) |
2 (0.2) |
0 |
Colon cancer, n |
2 |
0 |
LUCENT-2 MIRI Induction Responders |
MIRI 200 mg SC Q4W (n=389) |
PBO SC Q4W (n=192) |
LUCENT-2 Week 40 |
||
All malignancies, n (%) |
1 (0.3) |
1 (0.5) |
Gastric cancer, n |
1 |
0 |
Basal cell carcinoma, n |
0 |
1 |
LUCENT-2 MIRI Induction Delayed Responders |
OL Extended Induction |
OL Maintenance of Delayed Responders |
LUCENT-2 Week 12 |
LUCENT-2 Week 40 |
|
All malignancies, n (%) |
4 (1.3) |
1 (0.6) |
Squamous cell carcinoma, n |
2 |
0 |
Colon cancer, n |
1a |
0 |
Rectal cancer, n |
1 |
0 |
Kaposi's sarcoma, n |
0 |
1 |
LUCENT-3 |
OL Maintenance of MIRI Induction Responders |
|
Week 100b |
||
All malignancies, n (%) |
1 (0.3) |
|
Ongoing metastatic thyroid cancer, n |
1 |
|
Abbreviations: IV = intravenous; MIRI = mirikizumab; OL = open-label; PBO = placebo; Q4W = every 4 weeks; SC = subcutaneous.
Note: An additional rectal adenocarcinoma was discovered in the posttreatment follow-up period after LUCENT-1 and is not included in this table.
aThis case of colon cancer was originally discovered and reported during LUCENT-1. It was reported again during LUCENT-2.
bRepresents 152 weeks of continuous mirikizumab treatment.
References
1Data on file, Eli Lilly and Company and/or one of its subsidiaries.
2Ferrante M, D'Haens G, Jairath V, et al; VIVID Study Group. Efficacy and safety of mirikizumab in patients with moderately-to-severely active Crohn’s disease: a phase 3, multicentre, randomised, double-blind, placebo-controlled and active-controlled, treat-through study. Lancet. 2024;404(10470):2423-2436. https://doi.org/10.1016/S0140-6736(24)01762-8
3D'Haens G, Dubinsky M, Kobayashi T, et al; LUCENT Study Group. Mirikizumab as induction and maintenance therapy for ulcerative colitis. N Engl J Med. 2023;388(26):2444-2455. https://doi.org/10.1056/NEJMoa2207940
4Sands BE, D'Haens G, Clemow DB, et al. Three-year efficacy and safety of mirikizumab following 152 weeks of continuous treatment for ulcerative colitis: results from the LUCENT-3 open-label extension study. Inflamm Bowel Dis. Published online October 25, 2024. https://doi.org/10.1093/ibd/izae253
5Bernstein CN, Blanchard JF, Kliewer E, Wajda A. Cancer risk in patients with inflammatory bowel disease: a population-based study. Cancer. 2001;91(4):854-862. https://doi.org/10.1002/1097-0142(20010215)91:4<854::AID-CNCR1073>3.0.CO;2-Z
6Karlén P, Löfberg R, Broström O, et al. Increased risk of cancer in ulcerative colitis: a population-based cohort study. Am J Gastroenterol. 1999;94(4):1047-1052. https://doi.org/10.1111/j.1572-0241.1999.01012.x
7Jussila A, Virta LJ, Pukkala E, Färkkilä MA. Malignancies in patients with inflammatory bowel disease: a nationwide register study in Finland. Scand J Gastroenterol. 2013;48(12):1405-1413. https://doi.org/10.3109/00365521.2013.846402
8Burisch J, Lophaven S, Munkholm P, Langholz E. Surgery, cancer and mortality among patients with ulcerative colitis diagnosed 1962-1987 and followed until 2017 in a Danish population-based inception cohort. Aliment Pharmacol Ther. 2022;55(3):339-349. https://doi.org/10.1111/apt.16677
9Taborelli M, Sozzi M, Del Zotto S, et al. Risk of intestinal and extra-intestinal cancers in patients with inflammatory bowel diseases: a population-based cohort study in northeastern Italy. PLoS One. 2020;15(6):e0235142. https://doi.org/10.1371/journal.pone.0235142
10VA study sheds light on skin cancer risk in IBD, often related to therapy. US Medicine. May 11, 2021. Accessed December 5, 2024. https://www.usmedicine.com/2021-compendium-of-federal-medicine/va-study-sheds-light-on-skin-cancer-risk-in-ibd-often-related-to-therapy/
11van den Heuvel TR, Wintjens DS, Jeuring SF, et al. Inflammatory bowel disease, cancer and medication: cancer risk in the Dutch population-based IBDSL cohort. Int J Cancer. 2016;139(6):1270-1280. https://doi.org/10.1002/ijc.30183
12Jung YS, Han M, Park S, et al. Cancer risk in the early stages of inflammatory bowel disease in Korean patients: a nationwide population-based study. J Crohns Colitis. 2017;11(8):954-962. https://doi.org/10.1093/ecco-jcc/jjx040
13So J, Tang W, Leung WK, et al. Cancer risk in 2621 Chinese patients with inflammatory bowel disease: a population-based cohort study. Inflamm Bowel Dis. 2017;23(11):2061-2068. https://doi.org/10.1097/MIB.0000000000001240
Links to references and third-party websites are provided solely for your convenience and to facilitate easy access to the sources cited.
▼ 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.
Appendix
Additional Information on Colorectal Cancers in LUCENT-1 and LUCENT-2
Colorectal cancers were detected in 4 patients who received mirikizumab in the LUCENT clinical trial program, including
- 2 cases of colon adenocarcinoma at the end of the placebo-controlled induction period
- 1 case of colon adenocarcinoma (previously recorded at the end of LUCENT-1) and 1 case of rectal cancer after the open-label extended induction period, and
- 1 case of rectal adenocarcinoma discovered during the posttreatment follow-up period of LUCENT-1.1,3
These cancers may have been present but not visualized during the study entry endoscopy due to severe mucosal inflammation, and the cancers may have become more easily detected after the mucosal inflammation subsided.3
Additional Information on Nonmelanoma Skin Cancer in LUCENT-2
Basal cell carcinoma and squamous cell carcinoma were detected in 3 patients in the LUCENT clinical trial program, including
- 1 case of basal cell carcinoma at the end of LUCENT-2 in a mirikizumab LUCENT-1 induction responder rerandomized to placebo, and
- 2 cases of squamous cell carcinoma after the open-label extended induction period of LUCENT-2.3
Various studies have suggested that inflammatory bowel disease combined with modulatory medications increases the risk of skin cancer.10
Additional Information on Gastric Cancer in LUCENT-2
During LUCENT-2, 1 case of gastric cancer was detected in a mirikizumab-treated patient. The malignancy occurred in a Japanese patient with a family history that included gastric cancer and hepatic cancer.1
The patient permanently discontinued from the study and the study investigator did not consider the event related to mirikizumab.1
Estimates of the incidence rates of gastric cancer among patients with ulcerative colitis range from 0.006 to 0.043 per 100 patient years with the majority of studies reporting no significant association between ulcerative colitis and the risk for gastric cancer.1,5,7,9,12,13
Additionally, Japan has a reported incidence rate of gastric cancer at approximately 0.93 to 1.0 per 100 patient years.1
Additional Information on Kaposi's Sarcoma in LUCENT-2
During LUCENT-2, 1 case of Kaposi's sarcoma was detected in a mirikizumab-treated patient. The malignancy occurred in a Caucasian patient who tested negative for Human Immunodeficiency Virus (HIV) at study screening. The patient's negative HIV status was confirmed following diagnosis of the Kaposi's sarcoma.1
The patient permanently discontinued from the study and the study investigator did not consider the event related to mirikizumab.1
Date of Last Review: 15 January 2025