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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.

TREMFYA® (guselkumab)

Medical Information

TREMFYA - Use in Adult Patients with Plaque Psoriasis or Psoriatic Arthritis with a History of Malignancy

Last Updated: 07/04/2025

SUMMARY

The company cannot recommend any practices, procedures, or usage that deviates from the approved labeling.
In moderate to severe plaque psoriasis (PsO), a patient was excluded from participating in VOYAGE 1 and VOYAGE 2 if he/she currently had a malignancy or a history of malignancy except nonmelanoma skin cancer (NMSC) within 5 years.¹^,²
In a descriptive analysis of safety data from VOYAGE 1 and VOYAGE 2, malignancy events were reported among 18 patients with PsO who had a baseline history of malignancy (excluding NMSC) over a period of 5 years.³^,⁴
Two serious adverse events (SAEs) of malignancies (excluding NMSC) were reported among 19 patients with a history of malignancy (excluding NMSC) through 3 years of continuous treatment with TREMFYA in VOYAGE 1 and VOYAGE 2.⁵
In active psoriatic arthritis (PsA), a patient was excluded from participating in DISCOVER-1 and DISCOVER-2 if he/she currently had a malignancy or a history of malignancy within 5 years before screening (with the exception of an NMSC that had been adequately treated with no evidence of recurrence for at least 3 months before the first study drug administration or cervical carcinoma in situ that had been treated with no evidence of recurrence for at least 3 months before first study drug administration).⁶^,⁷
Three retrospective studies assessed the effectiveness and safety of TREMFYA in patients with moderate to severe PsO with a history of malignancy.⁸^-¹⁰
A case series and case report which described the use of TREMFYA in patients with PsO and a history of malignancy are summarized below.¹¹^,¹²

CLINICAL DATA IN moderate to severe PLAQUE PSOriasis

Phase 3 Studies

Blauvelt et al (2023)³ conducted a descriptive analysis of the safety of TREMFYA in patients with PsO with a history of malignancy (excluding NMSC). The study evaluated malignancy events in VOYAGE 1 and VOYAGE 2 through 5 years.

History of malignancy at baseline was reported in 18 of 1721 patients treated with TREMFYA.
Compared with the total TREMFYA-treated VOYAGE population, patients with prior malignancy were older (mean age, 60.8 vs 43.5 years), had longer PsO duration (mean, 23.6 vs 17.8 years), and had shorter TREMFYA exposure (median, 4.3 vs 4.7 years).
Of the 18 patients with prior malignancy, 15 (83%) patients achieved a final Psoriasis Area and Severity Index (PASI) of <1. One patient discontinued TREMFYA after 20 weeks of exposure due to lack of efficacy (baseline PASI score: 16.4; last visit PASI score: 7.0). See Table: Demographics and Outcomes in Patients with PsO with a History of Malignancy from VOYAGE 1 and VOYAGE 2.

Demographics and Outcomes in Patients with PsO with a History of Malignancy from VOYAGE 1 and VOYAGE 2³^,⁴

Treatment Phase	Demographics and Malignancy History	Treatment Exposure	Reason for Treatment D/C	Last PASI Score	Malignancy/SAE
VOYAGE 1
TREMFYA	A 76-year-old white male with a history of prostate cancer and BMI of 35.4 kg/m² Prior PUVA and topical treatment PsO duration: 8 years Baseline PASI score: 19.8	28.1 weeks	AE	0.3	New malignancy: Right breast lump observed ~1 year before study entry Diagnosis on day 202: subareolar right breast mass (2.7 cm) classified as grade 3 invasive ductal carcinoma with focal micropapillary features Gene mutation testing results were negative Metastasis detected in 2 of 6 lymph nodes Patient recovered after modified radical right mastectomy
TREMFYA	A 59-year-old white male with a history of prostate cancer and BMI of 29.7 kg/m² Prior acitretin, UST, MTX, UVB, and topical treatment PsO duration: 30 years Baseline PASI score: 20.8	253.7 weeks	-	0.3	SAEs other than malignancy: Diagnosis on day 1456: cellulitis (doubtful to be related to treatment; resolved)
TREMFYA	A 59-year-old white female with a history of cervical cancer and BMI of 41.5 kg/m² Prior topical treatment PsO duration: 30 years Baseline PASI score: 12	254.0 weeks	-	0	NR
TREMFYA	A 64-year-old white male with a history of testicular malignancy and BMI of 29.4 kg/m² Prior UVB and topical treatment PsO duration: 14 years Baseline PASI score: 14.4	244.4 weeks	COVID	0	NR
ADA crossover with TREMFYA	A 39-year-old white female with a history of thyroid malignancy and BMI of 20.2 kg/m² Prior PsO treatment: NR PsO duration: 28 years Baseline PASI score: 29.1	200.1 weeks	-	0	NR
ADA crossover with TREMFYA	A 54-year-old white female with a history of cervical cancer and BMI of 28 kg/m² Prior MTX, UVB, and topical treatment PsO duration: 30 years Baseline PASI score: 30.9	200.1 weeks	-	0	NR
Placebo crossover with TREMFYA	A 58-year-old white female with a history of melanoma and BMI of 24.2 kg/m² Prior topical treatment PsO duration: 39 years Baseline PASI: 15.9	234.9 weeks	-	0	NR
VOYAGE 2
TREMFYA	A 72-year-old white male with a history of rectal cancer and BMI of 34.0 kg/m² Prior MTX, UVB, and topical treatment PsO duration: 12 years Baseline PASI score: 16.4	173.1 weeks	AE	0	New malignancy: Diagnosis on day 394: BCC (left lower eyelid) Diagnosis on day 1168: sebaceous carcinoma (right lower eyelid); showed histopathologic features of SCC with focal sebaceous differentiation
TREMFYA	A 59-year-old Asian male with a history of colon cancer and BMI of 25.1 kg/m² Prior UVB and topical treatment PsO duration: 31 years Baseline PASI score: 13.2	252.1 weeks	-	0	NR
TREMFYA	A 64-year-old white female with a history of breast cancer and BMI of 36.6 kg/m² Prior topical treatment PsO duration: 3 years Baseline PASI score: 19.2	20.3 weeks	Lost to follow-up	0	SAEs other than malignancy: Diagnosis on day 127: cardiac failure (not related to treatment; resolved) Diagnosis on day 238: respiratory failure (not related to treatment; resolved)
TREMFYA	A 59-year-old white female with a history of melanoma and BMI of 25.8 kg/m² Prior acitretin, MTX, UVB, and topical treatment PsO duration: 8 years Baseline PASI score: 16.5	253.1 weeks	-	0	NR
TREMFYA	A 68-year-old white male with a history of DFSP and BMI of 31.9 kg/m² Prior topical treatment PsO duration: 45 years Baseline PASI score: 13.5	252.1 weeks	-	1.6	SAEs other than malignancy: Diagnosis on day 435: cellulitis (possibly related to treatment; resolved) Diagnosis on day 1201: presyncope (not related to treatment; not resolved) Diagnosis on day 1378: chest injury (not related to treatment; resolved)
TREMFYA	A 57-year-old white female with a history of breast cancer and BMI of 29.4 kg/m² Prior acitretin, MTX, PUVA, and topical treatment PsO duration: 49 years Baseline PASI score: 16.4	20.1 weeks	Lack of efficacy	7.0	SAEs other than malignancy: Diagnosis on day 204: noncardiac chest pain (not related to treatment; resolved) Diagnosis on day 231: herniated disk (not related to treatment; resolved)
ADA crossover with TREMFYA	A 57-year-old white male with a history of lung cancer and BMI of 36.6 kg/m²; smoker Prior MTX, UVB, and topical treatment PsO duration: 13 years Baseline PASI score: 15.0	74.1 weeks	AE	0.6	Recurrent malignancy: Diagnosis on day 753: recurrent right lower-lobe lung carcinoma with exophytic PD-L1-negative tumor growth (stage IVB; cT4N3M1c), infiltration into the middle lobe, and 3 brain metastases; poorly differentiated, noncornified SCC. Patient died ~4 months after treatment D/C.
ADA crossover with TREMFYA	A 69-year-old white male with a history of kidney and prostate cancer, and a BMI of 29.3 kg/m² Prior MTX, PUVA, and topical treatment PsO duration: 45 years Baseline PASI score: 20.0	223.0 weeks	-	0	NR
Placebo crossover with TREMFYA	A 71-year-old white male with a history of prostate cancer and BMI of 31.9 kg/m²; Fitzpatrick type I/II skin Prior topical treatment PsO duration: 4 years Baseline PASI score: 17.4	161.3 weeks	AE	0	New malignancy: Diagnosis on day 1139: right forearm invasive melanoma (ulcerated depth of ≥0.7 mm and 14 mitotic rate=3 cells/mm²) Patient had 2 BCCs during the study (day 211, left cheek; day 1139, left ankle). Melanoma resolved after surgical removal.
Placebo crossover with TREMFYA	A 57-year-old Asian female with a history of cervical cancer and BMI of 23.8 kg/m² Prior MTX, UVB, and topical treatment PsO duration: 10 years Baseline PASI score: 13.9	236.1 weeks	-	0	SAEs other than malignancy: Diagnosis on day 141: multiple fractures and subdural hemorrhage (not related to treatment; resolved)
Placebo crossover with TREMFYA	A 53-year-old white female with a history of cervical cancer and BMI of 34.7 kg/m² Prior topical treatment PsO duration: 26 years Baseline PASI score: 14.9	228.0 weeks	COVID	4.0	NR
Abbreviations: ADA, adalimumab; AE, adverse event; BCC, basal cell carcinoma; BMI, body mass index; COVID, coronavirus disease ; D/C, discontinuation; DFSP, dermatofibrosarcoma protuberans; MTX, methotrexate; NR, not reported; PASI, Psoriasis Area and Severity Index; PD-L1, programmed cell death 1 ligand 1; PsO, psoriasis; PUVA, psoralen + ultraviolet A; SAE, serious adverse event; SCC, squamous cell carcinoma; UST, ustekinumab; UVB, ultraviolet B.

Blauvelt et al (2019)⁵ reported the occurrence of SAEs of malignancies (excluding NMSC) through 3 years of continuous TREMFYA treatment in patients with a history of malignancy (excluding NMSC) during the VOYAGE 1 and VOYAGE 2 studies.

Of the 1826 patients in VOYAGE 1 and VOYAGE 2, 19 (1.0%) patients had a history of malignancy (excluding NMSC) at baseline (TREMFYA, n=10; placebo, n=4; adalimumab, n=5).
Prior malignancies included kidney, prostate, lung, testicular, thyroid, cervical, rectal, colon, and breast cancers, melanoma, and dermatofibrosarcoma.
SAEs of malignancies (excluding NMSC) were reported in 2 of the 19 patients.
- A 76-year-old patient with a history of prostate cancer (2007) who was treated with TREMFYA developed metastatic invasive papillary breast carcinoma on study day 202 of VOYAGE 1 and withdrew from the study. The patient recovered from this SAE.
- A 57-year-old patient with a history of squamous cell bronchial carcinoma (1997 to 2007) who was treated with adalimumab and crossed over to open-label TREMFYA during VOYAGE 2 had a recurrence with metastases at study day 753 and died.

real-world evidence

Retrospective Studies

Mortato et al (2025)⁸ conducted a retrospective multicenter study (EARLY study) to assess the clinical outcomes and safety of TREMFYA in patients with moderate to severe plaque PsO with chronic infections, malignancies, or heart disease.

Of the 1,024 patients enrolled in the study, 65 (6.3%) patients had cancer, with 51 (78%) patients classified in the Precedent Cancer (PC) group (diagnosed before initiating treatment with TREMFYA) and 14 (22%) patients in the Intercurrent Cancer (IC) group (diagnosed during treatment with TREMFYA).
The mean (SD) time from cancer diagnosis to initiating TREMFYA ranged from 34.6 (43.5) months for hematological cancer to 89.6 (57.0) months for gastrointestinal tract cancers.
The mean (standard deviation [SD]) follow-up duration for patients receiving TREMFYA after cancer diagnosis ranged from:
- PC group: 95.2 (70.9) weeks for breast cancer to 164.7 (79.1) weeks for melanoma
- IC group: 26.0 weeks for ‘other tumors’ (n=1) to 150.0 (66.4) weeks for genitourinary system tumors.
In the PC group, genitourinary system tumors were most common (n=15), followed by breast (n=9), gastrointestinal (n=8), melanoma (n=7), other tumors (n=5), hematological cancers (n=4), and lung cancer (n=3).
In the IC group, genitourinary tumors and lung cancer were equally frequent (n=4 each), followed by hematological cancers (n=2), and breast, gastrointestinal, melanoma, and other tumors (n=1 each).
Three patients (lung cancer, n=2; non-Hodgkin lymphoma [NHL], n=1) discontinued TREMFYA immediately after cancer diagnosis.
Based on cancer risk, patients were stratified into low-risk group (NMSC and nonrecurrence >5 years) and high-risk group (active cancers and recently diagnosed).
The mean (SD) time from cancer diagnosis to initiating TREMFYA was:
- High-risk group: 11.8 (15.5) months
- Low-risk group: 113.3 (58.5) months
The mean (SD) follow-up duration for patients receiving TREMFYA was:
- High-risk group: 116.3 (76.6) weeks
- Low-risk group: 119.3 (76.3) weeks
No new cancer recurrences or progression were observed.

Gracia Cazaña et al (2024)⁹ conducted a retrospective multicenter study to assess the safety and efficacy of TREMFYA in patients with moderate to severe PsO and a history of malignancy.

Patients >18 years of age treated with TREMFYA with a diagnosis of neoplasm in the last ≤5 years were included (n=20), and patients with <12 weeks of follow-up period were excluded.
Of the 20 patients enrolled in the study, 14 patients had active cancers, with an average time from cancer diagnosis of 3.6 years.
The mean follow-up time was 36 weeks, and the maximum and median follow-up periods were both 52 weeks.
All patients were previously treated with systemic and biologic therapies, including adalimumab (n=10), etanercept (n=9), and apremilast (n=9).
- Prior to switching to TREMFYA, the majority of patients were previously treated with apremilast (n=10) and ustekinumab (n=6).
Most malignancies were solid tumors, including head and neck cancer (n=3), melanoma (n=2), and endometrial cancer (n=2). Other tumor types were vulvar (n=1), breast (n=2), cervical (n=1), colon (n=1), prostate (n=5), chronic lymphocytic leukemia (n=1), Kaposi sarcoma (n=1), and larynx (n=1).
The percentage of patients achieved PASI ≤3 at weeks 12 and 52 was 80% and 87.5%, respectively; 68.8% of patients achieved PASI ≤1.
Clinical outcomes including mean PASI, body surface area, Dermatology Life Quality Index (DLQI), and pruritus visual analog scale (VAS) scores from baseline to week 52 are presented in Table: Clinical Outcomes from Baseline to Week 52.

Clinical Outcomes from Baseline to Week 52⁹

Clinical Outcome, Mean (SD)	Baseline	Week 4	Week 12	Week 52
PASI	13.6 (7.0)	1.9 (2.05)^a	1.8 (2.3)^a	1.65 (3.8)^a
BSA	26.1 (30.35)	4 (4.54)^c	2.1 (3)^d	1.4 (2.6)^d
DLQI	9.3 (8.1)	1.7 (1.4)^d	1.4 (2.7)^b	0.45 (0.9)^b
Pruritus VAS	4.4 (3)	1.6 (1.7)^c	0.6 (1.1)^b	0^b
Abbreviations: BSA, body surface area; DLQI, Dermatology Life Quality Index; PASI, Psoriasis Area Severity Index; SD, standard deviation; VAS, visual analog scale. ^aP<0.0001. ^bP<0.001. ^cP<0.05. ^dP<0.01.

At the end of the study, a 52-week survival rate of 100% (n=20) was observed, including patients with concomitant active cancers (n=14).
No AEs, SAEs or discontinuations related to the TREMFYA safety profile were reported in patients with or without active cancer.

Al-Rabai et al (2023)¹⁰ conducted a 60-week retrospective study to assess the real-world effectiveness and safety of TREMFYA in adults with moderate-to-severe plaque PsO, including patients with a history of malignancy.

A total of 104 patients were included in this study.
Six patients had a history of malignancy, including cutaneous melanoma, bladder cancer, colon cancer, papillary thyroid carcinoma, breast cancer, and NHL.
All patients were in remission and had a cancer diagnosis ≥4 years prior to initiating TREMFYA treatment.
No recurrence of cancer was observed in any of the six patients during the 60-week follow-up period.

Case Series/Case Reports

Mastorino et al (2022)¹¹ evaluated safety and effectiveness of TREMFYA in patients with moderate to severe PsO and a prior history of cancer.

Of 75 patients treated with TREMFYA, 7 had a prior history of malignancy, including NMSC (basal cell carcinoma/squamous cell carcinoma [n=3]), melanoma (n=1), leiomyosarcoma (n=1), clear cell renal carcinoma (n=1), and ductal breast cancer (n=1)
Two of 7 patients had received prior biologics (etanercept and adalimumab, n=1; ustekinumab, n=1).
All patients were treated with TREMFYA for at least 11 months, with regular ongoing follow-up.
PASI >70 was achieved in 6 patients. One patient discontinued treatment after one year due to intolerance.
All patients experienced low-grade neoplasia, however possible concern of cancer recurrence was not observed with TREMFYA.

Kamiya et al (2020)¹² reported a case of a 58-year-old male patient with non-small cell lung cancer and plaque PsO treated with carboplatin (CBDCA) plus nanoparticle albumin-bound paclitaxel (nab-PTX) therapy and TREMFYA.

The patient received cyclosporine 150-300 mg/day for 6 years with well-controlled skin lesions. However, the patient was subsequently administered ustekinumab due to deterioration in renal function.
Twenty-five months after treatment with ustekinumab, computed tomography showed a nodular lesion in the left upper lobe, indicating lung cancer. Ustekinumab was then replaced with apremilast.
After 2 months, apremilast was discontinued due to worsening skin lesions and TREMFYA was then initiated.
Three months after the administration of TREMFYA, a diagnosis of lung adenocarcinoma was made from histopathological findings of transbronchial lung biopsy, leading to temporary discontinuation of TREMFYA.
The patient was started with CBDCA plus nab-PTX for advanced non-small cell lung cancer (cT2aN3M0, stage IIIB).
The nodular lung cancer lesion showed very good partial response after treatment with 4 courses of CBDCA plus nab-PTX.
The skin lesions deteriorated during treatment with CBDCA plus nab-PTX and ameliorated after the re-administration of TREMFYA.
Further deterioration of skin lesions was not observed, and no lung cancer relapse was observed for over 3 months.

LITERATURE SEARCH

A literature search of MEDLINE^®, EMBASE^®, BIOSIS Previews^®, and DERWENT^® (and/or other resources, including internal/external databases) was conducted on 21 May 2025.

References

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1	Blauvelt A, Papp KA, Griffiths CE, et al. Efficacy and safety of guselkumab, an anti-interleukin-23 monoclonal antibody, compared with adalimumab for the continuous treatment of patients with moderate to severe psoriasis: results from the phase III, double-blinded, placebo- and active comparator-controlled VOYAGE 1 trial. J Am Acad Dermatol. 2017;76(3):405-417.
2	Reich K, Armstrong AW, Foley P, et al. Efficacy and safety of guselkumab, an anti-interleukin-23 monoclonal antibody, compared with adalimumab for the treatment of patients with moderate to severe psoriasis with randomized withdrawal and retreatment: results from the phase III, double-blind, placebo- and active comparator-controlled VOYAGE 2 trial. J Am Acad Dermatol. 2017;76(3):418-431.
3	Blauvelt A, Thaçi D, Papp KA, et al. Safety of guselkumab in patients with psoriasis with a history of malignancy: 5-year results from the VOYAGE 1 and VOYAGE 2 trials. Br J Dermatol. 2023;189(1):132-134.
4	Blauvelt A, Thaçi D, Papp KA, et al. Safety of guselkumab in psoriasis patients with a history of malignancy: 5-year results from the VOYAGE 1 and 2 trials. Oral presentation presented at: 30th European Academy of Dermatology and Venereology (EADV) congress; September 29-October 2, 2021; Virtual.
5	Blauvelt A, Papp KA, Ho V, et al. Experience in patients with a history of malignancy through 3 years of continuous treatment with guselkumab in the VOYAGE 1 and 2 trials. Poster presented at: American Academy of Dermatology Annual Meeting; March 1-5, 2019; Washington, DC.
6	Deodhar A, Helliwell PS, Boehncke WH, et al. Supplement to: Guselkumab in patients with active psoriatic arthritis who were biologic-naive or had previously received TNFα inhibitor treatment (DISCOVER-1): a double-blind, randomised, placebo-controlled phase 3 trial. Lancet. 2020;395(10230):1115-1125.
7	Mease PJ, Rahman P, Gottlieb AB, et al. Supplement to: Guselkumab in biologic-naive patients with active psoriatic arthritis (DISCOVER-2): a double-blind, randomised, placebo-controlled phase 3 trial. Lancet. 2020;395(10230):1126-1136.
8	Mortato E, Talamonti M, Marcelli L, et al. A long-term real-world safety study of guselkumab in patients with psoriasis who have infectious comorbidities, malignancies or heart disease: the EARLY study. [published online ahead of print April 16, 2025]. Clin Exp Dermatol. doi:10.1093/ced/llaf172.
9	Gracia Cazaña T, Riera Monroig J, Izu R, et al. Real-world outcomes in patients with malignancy and moderate-to-severe psoriasis treated with guselkumab. JAAD Int. 2024;16:66-71.
10	Al-Rabai M, Al-Ghanemi L, Julia S, et al. A 60week realworld experience with guselkumab in patients with moderatetosevere Plaque psoriasis Including patients with malignancy: a retrospective study from Ontario, Canada. J Dermatol Dermatol Surg. 2023;27(2):90-92.
11	Mastorino L, Siliquini N, Avallone G, et al. Seven cancer patients receiving guselkumab for treatment of moderate-to-severe psoriasis. Dermatol Rep. 2022;14(3):9282.
12	Kamiya K, Yamauchi H, Ohtsuki M. Treatment of psoriasis vulgaris with guselkumab in a patient with non-small cell lung cancer. Eur J Dermatol. 2020;30(5):609-611.

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