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ICOTYDE®

(icotrokinra)

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ICOTYDE® (icotrokinra)
Medical Information

ICOTYDE - Occurrence of Malignancies in Patients with Plaque Psoriasis

Last Updated: 10/15/2026

SUMMARY

  • The safety and efficacy of ICOTYDE (icotrokinra) in patients with moderate to severe plaque psoriasis (PsO) was evaluated in the ICONIC-LEAD (NCT06095115), ICONIC-TOTAL (NCT06095102), ICONIC-ADVANCE 1 (NCT06143878), and ICONIC-ADVANCE 2 (NCT06220604) phase 3 clinical trials.1-3
  • The following pooled analysis summarizes the exposure-adjusted incidence rates (EAIR) of malignancy per 100 patient-years (PY) of follow-up across these studies.4
    • Through week 52, EAIRs per 100 PY (95% confidence interval [CI]) in patients treated with icotrokinra were 0.54 (0.24-0.95) for all malignancies, 0.16 (0.00-0.43) for nonmelanoma skin cancer (NMSC), and 0.38 (0.13-0.74) for other malignancies.

CLINICAL DATA

Pooled Analysis Of Phase 3 Clinical Trials

Lebwohl et al (2026)4 evaluated the 1-year safety profile of icotrokinra using pooled data from the LEAD, TOTAL, ADVANCE 1, and ADVANCE 2 studies.

Study Design/Methods


Overview of Phase 3 Clinical Trials through Week4
LEAD
TOTAL
ADVANCE 1 and ADVANCE 2
Overview
  • Multicenter, randomized, controlled, double-blind, phase 3 clinical trials
Key inclusion criteria
  • Age ≥12 years
  • IGA ≥3
  • PASI ≥12
  • BSA ≥10%
  • Candidate for phototherapy or systemic treatment
  • Age ≥12 years
  • IGA ≥2
  • BSA ≥1%
  • ≥1 high-impact site with at least moderate PsO (ss-IGA ≥3, sPGA-G ≥3, or hf-PGA ≥3)
  • Failed ≥1 topical therapy
  • Candidate for phototherapy or systemic treatment
  • Age ≥18 years
  • IGA ≥3
  • PASI ≥12
  • BSA ≥10%
  • Candidate for phototherapy or systemic treatment
Treatment groups
  • ICO (n=456)
    • ICO 200 mg QD W0-24
    • W24–52: randomized withdrawal and retreatmenta
  • PBO (n=228)
    • PBO QD W0-16
    • ICO 200 mg QD W16-52
  • ICO (n=208)
    • ICO 200 mg QD W0-52
  • PBO (n=103)
    • PBO QD W0-16
    • ICO 200 mg QD W16-52
  • ICO (ADVANCE 1, n=311; ADVANCE 2, n=322)
    • ICO 200 mg QD W0-52
  • PBO (ADVANCE 1, n=156; ADVANCE 2, n=82)
    • PBO QD W0-16
    • ICO 200 mg QD W16-52
  • Deucra (ADVANCE 1, n=307; ADVANCE 2, n=327)
    • Deucra 6 mg QD W0-24
    • ICO 200 mg QD W24-52
Abbreviations: BSA, body surface area; Deucra, deucravacitinib; hf-PGA, Physician’s Global Assessment of hands and feet; ICO, icotrokinra; IGA, Investigator’s Global Assessment; PASI, Psoriasis Area and Severity Index; PBO, placebo; PsO, psoriasis; QD, once daily; sPGA-G, static Physician’s Global Assessment of Genitalia; ss-IGA, scalp-specific Investigator’s Global Assessment; W, week.
aBased on PASI 75 and IGA 0/1 response (adults only; all adolescents continued ICO).

Results

Baseline Characteristics

Select Baseline Demographics and Medical History by Study4
LEAD
n=684
TOTAL
n=311
ADVANCE 1
n=772
ADVANCE 2
n=731
Overall
n=2498
Age, years, mean (SD)
42.6 (16.4)
44.7 (14.3)
46.7 (13.4)
46.1 (13.6)
45.2 (14.5)
Male sex, n (%)
447 (65.4)
200 (64.3)
526 (68.1)
496 (67.9)
1669 (66.8)
Race, n (%)
    White
494 (72.2)
243 (78.1)
568 (73.6)
604 (82.6)
1909 (76.4)
    Asian
167 (24.4)
61 (19.6)
180 (23.3)
89 (12.2)
497 (19.9)
    Black or African American
8 (1.2)
2 (0.6)
11 (1.4)
22 (3.0)
43 (1.7)
BMI,a kg/m2, mean (SD)
29.3 (7.0)
29.2 (7.1)
29.5 (7.1)
29.8 (6.5)
29.5 (6.9)
Medical history, n (%)
   Skin basal cell carcinoma
3 (0.4)
1 (0.3)
5 (0.6)
5 (0.7)
14 (0.6)
   Skin squamous cell carcinoma
2 (0.3)
1 (0.3)
3 (0.4)
3 (0.4)
9 (0.4)
   Current or former nicotine useb
273 (39.9)
142 (45.7)
396 (51.3)
358 (49.0)
1169 (46.8)
   Family history of cancer in 1st degree relativec
117 (17.1)
62 (19.9)
168 (21.8)
149 (20.4)
496 (19.9)
Abbreviations: BMI, body mass index; SD, standard deviation.
aLEAD, n=682; TOTAL, n=304; ADVANCE 2, n=729; Overall, n=2487.
bIncludes cigarettes, cigars, pipes, smokeless tobacco, patches/gum, and e-cigarettes or equivalent.
cExcluding skin squamous cell and basal cell carcinomas.
Safety

Select Safety Results Across Analysis Periods through Week 524,5

PBO-controlled
(W0-16)a
Active-controlled
(W0-24)b
Through
W52c
ICO
n=1296
PBO
n=568
ICO
n=632
Deucra
n=634
ICO
n=2400
Total PY of follow-up
395
170
285
283
1840
Average follow-up, weeks
15.9
15.6
23.5
23.3
40.0
EAIRs of events/100 PY of follow-up (95% CI)d
    Malignancy
1.50
(0.95-4.07)
0.54
(0.31-5.79)
1.05
(0.22-3.30)
0.71
(0.03-2.80)
0.54
(0.24-0.95)
        NMSC
0.22
(0.15-2.32)
0
(0.00-5.03)
0.35
(0.00-2.25)
0
(0.00-1.69)
0.16
(0.00-0.43)
        Other malignancy
1.28
(0.79-3.79)
0.54
(0.31-5.80)
0.70
(0.03-2.78)
0.71
(0.03-2.80)
0.38
(0.13-0.74)
Abbreviations: CI, confidence interval; Deucra, deucravacitinib; EAIR, exposure-adjusted incidence rate; ICO, icotrokinra; NMSC, nonmelanoma skin cancer; PBO, placebo; PY, patient-years; W, week.
aIncludes LEAD, TOTAL, ADVANCE 1, and ADVANCE 2. To account for the different PBO:ICO randomization ratio in ADVANCE 2 vs the other studies, rates were adjusted by the total follow-up from the combined PBO and ICO treatment groups in a study.
bIncludes data from ADVANCE 1 and ADVANCE 2 only.
cIncludes data for patients randomized to ICO, data after W16 for patients randomized to PBO who crossed over to ICO, and data after W24 for patients randomized to Deucra who switched to ICO. For the LEAD study, events that occurred during the withdrawal period (on or after W28 and before re-treatment) were excluded for patients who were re-randomized to PBO at W24.
dCalculated as (number of patients with AEs/total PY at risk) x 100. Patients are counted only once for any given event, regardless of the number of times they actually experienced the event.

Malignancies

  • Through week 16 (LEAD, TOTAL, ADVANCE 1, and ADVANCE 2)4:
    • Six patients with malignancies (7 events) were reported in the icotrokinra group (EAIR, 1.50/100 PY):
      • Two events of squamous cell carcinoma (SCC; keratoacanthoma type) on days 35 and 66 in a patient with prior history of keratoacanthoma.
      • One event of malignant melanoma in situ (day 110) in a patient with prior history of malignant melanoma.
      • One event of prostate cancer (day 57) in a patient with elevated prostate-specific antigen levels at baseline.
      • One event of colon adenocarcinoma (day 15) in a patient with pre-existing symptoms.
      • One event of pancreatic cancer with liver metastasis (day 60).
      • One event of breast cancer (day 14).
  • Through week 24 (ADVANCE 1 and ADVANCE 2)4:
    • No additional malignancies were reported in the icotrokinra group beyond those observed through week 16 (cumulative EAIR, 1.05/100 PY).
  • Through week 52 (LEAD, TOTAL, ADVANCE 1, and ADVANCE 2)4:
    • Two additional NMSC events, both SCC, were reported (cumulative EAIR, 0.16/100 PY).
    • Two additional other malignancies, prostate cancer and chronic lymphocytic leukemia, were reported (cumulative EAIR, 0.38/100 PY).
  • Through week 52, the number of malignancies other than NMSC and cervical cancer in situ among patients treated with icotrokinra (n=7) was similar to the number expected in the general US population, adjusted for age, sex, and race (n=8.79), based on the National Cancer Institute (NCI) Surveillance, Epidemiology, and End Results (SEER) database (2000–2021).4
    • The corresponding standardized incidence ratio (SIR) versus SEER reference rates was 0.80 (95% CI, 0.32–1.64).

Literature Search

A literature search of MEDLINE®, EMBASE®, BIOSIS Previews®, and DERWENT® (and/or other resources, including internal/external databases) was conducted on 06 October 2026.

References

Show
1 Bissonnette R, Soung J, Hebert AA, et al. Oral icotrokinra for plaque psoriasis in adults and adolescents. N Engl J Med. 2025;393(18):1784-1795.  
2 Gooderham M, Lain E, Bissonnette R, et al. Targeted oral peptide icotrokinra for psoriasis involving high-impact sites. NEJM Evid. 2025;4(12):EVIDoa2500155.  
3 Stein Gold L, Armstrong AW, Bissonnette R, et al. Once-daily oral icotrokinra versus placebo and once-daily oral deucravacitinib in participants with moderate-to-severe plaque psoriasis (ICONIC-ADVANCE 1 & 2): two phase 3, randomised, placebo-controlled and active-comparator-controlled trials. Lancet. 2025;406(10510):1363-1374.  
4 Lebwohl MG, Gooderham M, Warren RB, et al. Safety of icotrokinra through 1 year for the treatment of moderate-to-severe plaque psoriasis and psoriasis affecting high-impact sites: pooled results across the ICONIC-LEAD, ICONIC-TOTAL, and ICONIC-ADVANCE 1 and 2 phase 3 trials. [published online ahead of print August 28, 2026]. Dermatol Ther (Heidelb). doi: 10.1007/s13555-026-01885-w.  
5 Data on File. Icotrokinra 120-day safety update. Janssen Research & Development, LLC. EDMS-RIM-1606208; 2025.  

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