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Omvoh ® ▼ (mirikizumab)
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Omvoh® (mirikizumab): Incidence of malignancies in LUCENT clinical trials
The incidence of malignancies was 0.2% in LUCENT-1 induction study and 1.3% in LUCENT-2 maintenance study. No malignancies were reported during the interim safety analysis of LUCENT-3.
Content Overview
Treatment-Emergent malignancies in LUCENT-1 and LUCENT-2 clinical trials
LUCENT-1
In the 12-week induction study of mirikizumab for the treatment of ulcerative colitis, LUCENT-1, malignancies were reported in
- 2 of 958 patients (0.2%) who received mirikizumab (2 cases of colon cancer), and
- 0 of 321 patients who received placebo (Frequency of Malignancies in the LUCENT-1 and LUCENT-2 Clinical Trials).1
LUCENT-2
Mirikizumab Induction Responders
Of the patients who responded to induction therapy with mirikizumab and participated in the 40-week maintenance study, LUCENT-2, malignancies were reported in
- 1 of 389 patients (0.3%) who were re-randomized to mirikizumab (gastric cancer in a Japanese patient), and
- 1 of 192 patients (0.5%) who were re-randomized to placebo (basal cell carcinoma) (Frequency of Malignancies in the LUCENT-1 and LUCENT-2 Clinical Trials).1
Mirikizumab Induction Nonresponders
Patients who did not achieve a clinical response to either mirikizumab or placebo during the 12-week induction phase of LUCENT-1 received open-label extended induction treatment with an additional 3 doses of mirikizumab 300 mg infused intravenously every 4 weeks for the first 12 weeks of LUCENT-2.
- Malignancies were reported in 4 of 313 (1.3%) of these patients, including
- 2 cases of squamous cell carcinoma,
- 1 case of colon cancer (previously reported in LUCENT-1) , and
- 1 case of rectal cancer (Frequency of Malignancies in the LUCENT-1 and LUCENT-2 Clinical Trials).1,2
Patients who achieved a clinical response compared with LUCENT-1 baseline with extended induction therapy received open-label maintenance dosing with mirikizumab 200 mg injected subcutaneously every 4 weeks through week 40 of LUCENT-2.
- 1 malignancy (Kaposi's sarcoma) was reported in these 171 patients (0.6%) (Frequency of Malignancies in the LUCENT-1 and LUCENT-2 Clinical Trials).1
Event |
Treatment Arm |
|
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 Nonresponders |
OL Induction MIRI 300 mg IV (N=313) |
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 |
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 post-treatment 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.
Additional Information on Colorectal Cancers
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 post-treatment follow-up period of LUCENT-1.1,2
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.1
Estimates of the incidence rates of colon cancer among patients with ulcerative colitis range from 0.04 to 0.16 per 100 patient years with the majority of studies reporting a significant association between ulcerative colitis and the risk for colon cancer.2-6
Estimates of the incidence rates of cancer of the rectum among patients with ulcerative colitis range from 0.034 to 0.063 per 100 patient years with the majority of studies reporting a significant association between ulcerative colitis and the risk for cancer of the rectum.2-7
Additional Information on Non-Melanoma Skin Cancer
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-2.1
Various studies have suggested that inflammatory bowel disease combined with modulatory medications increases the risk of skin cancer.8
Additional Information on Gastric Cancer
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.2
The patient permanently discontinued from the study and the study investigator did not consider the event related to mirikizumab.2
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.2,3,5,7,10,11
Additionally, Japan has a reported incidence rate of gastric cancer at approximately 0.93 to 1.0 per 100 patient years.2
Additional Information on Kaposi's Sarcoma
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.2
The patient permanently discontinued from the study and the study investigator did not consider the event related to mirikizumab.2
LUCENT-3 clinical trials
LUCENT-3 is a single-arm, open-label, phase 3, long-term extension study evaluating the efficacy and safety of mirikizumab in patients with moderately to severely active ulcerative colitis who have participated in a previous mirikizumab ulcerative colitis study, including, but not limited to, the phase 2 study AMAC and LUCENT-2. The planned maximum duration of treatment for each patient is approximately 3 years.12
The interim safety analysis of LUCENT-3 included data for patients (N=289) between weeks 52 and 104 of the LUCENT clinical trial program.13,14
During the interim analysis of LUCENT-3, no malignancies were reported.13
The LUCENT study data continue to be finalized and this information will be updated with any additional findings.
References
1D'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
2Data on file, Eli Lilly and Company and/or one of its subsidiaries.
3Bernstein 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
4Karlén 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
5Jussila 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
6Burisch 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
7Taborelli 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
8VA study sheds light on skin cancer risk in IBD, often related to therapy. U.S. Medicine. May 11, 2021. Accessed November 02, 2023. https://www.usmedicine.com/2021-compendium-of-federal-medicine/va-study-sheds-light-on-skin-cancer-risk-in-ibd-often-related-to-therapy/
9van 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
10Jung 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
11So 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
12US National Library of Medicine. ClinicalTrials.gov. February 29, 2000. Accessed November 02, 2023. https://clinicaltrials.gov/
13Sands BE, D'Haens G, Clemow DB, et al. Two-year efficacy and safety of mirikizumab following 104 weeks of continuous treatment: interim results from the LUCENT-3 open-label extension study. Abstract presented at: United European Gastroenterology Week; October 14-17, 2023; Copenhagen, Denmark.
14Sands BE, D'Haens G, Clemow DB, et al. Two-year efficacy and safety of mirikizumab following 104 weeks of continuous treatment: interim results from the LUCENT-3 open-label extension study. Poster presented at: United European Gastroenterology Week; October 14-17, 2023; Copenhagen, Denmark.
▼ 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: 02 November 2023