J&J Medical Connect
icotrokinra
J&J Medical Connect

Connect with us

Connect with us

This information is intended for US healthcare professionals to access current scientific information about J&J Innovative Medicine products. It is prepared by Medical Information and is not intended for promotional purposes, nor to provide medical advice.

icotrokinra

Medical Information

Icotrokinra – Occurrence of Malignancies in Patients with Plaque Psoriasis

Last Updated: 01/29/2026

SUMMARY

  • Icotrokinra (JNJ-77242113) is a targeted oral peptide that selectively binds the interleukin-23 (IL-23) receptor and inhibits IL-23 pathway signaling.1 
  • The safety of icotrokinra in patients with moderate to severe plaque psoriasis (PsO) was evaluated in the ICONIC-LEAD, ICONIC-TOTAL, ICONIC-ADVANCE 1, and ICONIC-ADVANCE 2 phase 3 clinical trials. The following summarizes the incidence of malignancies across these studies.1-3 
    • The incidence rate of malignancies reported in the icotrokinra group was less than 1% through week 52 in ICONIC-LEAD, 1% through week 52 in ICONIC-TOTAL, and less than 1% through week 24 in the ICONIC-ADVANCE 1 and ICONIC-ADVANCE 2 combined safety analysis.

CLINICAL DATA

ICONIC-LEAD

Bissonnette et al (2025)1 and Soung et al (2025)4 evaluated the efficacy and safety of oral icotrokinra 200 mg daily in patients ≥12 years of age with moderate to severe plaque PsO in an ongoing phase 3, multicenter, randomized, double-blind, placebo (PBO)-controlled study with randomized withdrawal and retreatment (NCT06095115).


Incidence of Cancer Through Week 52 in ICONIC-LEAD1,4,5 
PBO-Controlled
(Adults & Adolescents)
Active Treatment
(Adults & Adolescents)
ICO Responders Re-Randomized at W24 (Adults)
ICO
N=456
PBO
N=228
ICO
N=456
ICOa
N=213
ICO→ICO N=168
ICO→PBOb N=172
Treatment period
W0-16
W0-52
W16-52
W24-52
Mean weeks of follow-up
15.9
15.8
43.4
35.3
27.7
27.8
Cancer, n (%)
2 (<1)c
0
2 (<1)c
0
0
0
Abbreviations: ICO, icotrokinra; PBO, placebo; W, week.
aIncludes data after week 16 for PBO-randomized patients who crossed over to receive ICO.bCombined withdrawal and retreatment group.cIncluded adenocarcinoma of the colon (a 64-year-old female who had a history of smoking, reported mild gastroenteritis during screening, severe colitis starting on study day 7, and severe ileus on day 14 was diagnosed with grade 3 adenocarcinoma of the colon on day 19) and prostate cancer (a 62-year-old male who had a history of smoking, a family history of prostate cancer, and an elevated prostate-specific antigen level prior to baseline was diagnosed with grade 1 prostate cancer on study day 48).

ICONIC-TOTAL

Gooderham et al (2025)2 and Lain et al (2025)6 evaluated the efficacy and safety of oral icotrokinra 200 mg daily in patients ≥12 years of age with moderate to severe plaque PsO affecting special sites (scalp, genitals, and/or palms of the hands and soles of the feet) in an ongoing phase 3, multicenter, randomized, double-blind, PBO-controlled study (NCT06095102).


Incidence of Malignancies Through Week 52 in ICONIC-TOTAL6 
PBO-Controlled
Crossover
Active Treatment
ICO
N=208
PBO
N=103
PBO→ICO
N=92
ICO
N=208
ICO Combineda N=300
Treatment period
W0-16
W16-52
W0-52
Mean weeks of follow-up
16.0
15.6
36.2
49.3
45.3
Malignancyb, n (%)
1 (<1)
0
0
2 (1)
2 (1)
Abbreviations: ICO, icotrokinra; PBO, placebo; W, week.
aIncludes data for ICO-randomized patients through W52 and for PBO-to-ICO patients from W16 through W52.bIncludes chronic lymphocytic leukaemia and malignant melanoma in situ (in a patient with a history of melanoma and dysplastic nevi).

ICONIC-ADVANCE 1 and ICONIC-ADVANCE 2

Stein Gold et al (2025)3 evaluated the efficacy and safety of oral icotrokinra 200 mg daily in adults with moderate to severe plaque PsO in 2 ongoing, phase 3, multicenter, randomized, double-blind studies comparing icotrokinra with PBO and deucravacitinib (NCT06143878 and NCT06220604).


Incidence of Malignancies Through Week 24 in the Combined Safety Analysis Set (ICONIC-ADVANCE 1 and ICONIC-ADVANCE 2)3,7 
PBO-Controlled
Active Comparator-Controlled
Crossover
ICO
N=632
PBO
N=237
Deucra
N=634
ICO
N=632
Deucra
N=634
PBO→ICO
N=215
Treatment period
W0-16
W0-24
W16-24
Mean weeks of follow-up
15.9
15.5
15.8
23.5
23.3
8.1
Malignancya, n (%)
3 (<1)
1 (<1)
1 (<1)
3 (<1)
2 (<1)
0
Abbreviations: Deucra, deucravacitinib; ICO, icotrokinra; PBO, placebo; W, week.
aDetails on malignancies reported through Week 24 of both studies are provided as early as Week 4.Note: The safety analysis set included all randomized and treated participants.
  • Through week 24, there were 6 instances of malignancy reported across ICONIC-ADVANCE 1 and ICONIC-ADVANCE 27:
    • Three in the icotrokinra group (pancreatic carcinoma, invasive breast carcinoma, and keratoacanthoma)
    • One in the PBO group (invasive ductal breast carcinoma)
    • Two in the deucravacitinib group (right buccal squamous cell carcinoma and malignant melanoma in situ)
    • All events were considered unrelated to study treatments by investigators.

Literature Search

A literature search of MEDLINE®, EMBASE®, BIOSIS Previews®, and DERWENT® (and/or other resources, including internal/external databases) was conducted on 19 December 2025.

 

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).  
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. The Lancet. 2025;406(10510):1363-1374.  
4 Soung J, Cui Y, Bissonnette R, et al. Maintenance of response with icotrokinra, a targeted oral peptide, for the treatment of moderate-to-severe plaque psoriasis: randomized treatment withdrawal in adults (weeks 24-52) and continuous treatment in adolescents (through week 52) from the phase 3, ICONIC-LEAD trial. Oral Presentation presented at: European Academy of Dermatology and Venereology (EADV); September 17-20, 2025; Paris, France.  
5 Bissonnette R, Soung J, Hebert AA, et al. Supplement to: Oral icotrokinra for plaque psoriasis in adults and adolescents. N Engl J Med. 2025;393:1784-1795.  
6 Lain E, Warren RB, Gooderham M, et al. Durability of response to the targeted oral peptide icotrokinra for high-impact site psoriasis: 1-year ICONIC-TOTAL findings. Poster presented at: Fall Clinical Dermatology Conference; October 23-26, 2025; Las Vegas, NV.  
7 Stein Gold L, Armstrong AW, Bissonnette R, et al. Supplement to: 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. The Lancet. 2025;406(10510):1363-1374.