trialsTrialActive

An Efficacy and Safety Study of Erdafitinib (JNJ-42756493) in Participants With Urothelial Cancer

A phase 2 trial of Erdafitinib in bladder & urothelial cancer, run by Janssen Research & Development, LLC, active and no longer recruiting.

An Efficacy and Safety Study of Erdafitinib (JNJ-42756493) in Participants With Urothelial Cancer is a phase 2 interventional study registered as NCT02365597 by Janssen Research & Development, LLC, with 239 participants enrolled, started 2015-04-22 and due to reach its primary completion in 2022-09-15. Interventions recorded: Erdafitinib, Midazolam and Metformin. Results have been posted on the registry.

Setting

A Phase 2, Two-arm Multicenter, Open-Label Study to Determine the Efficacy and the Safety of Two Different Dose Regimens of a Pan-FGFR Tyrosine Kinase Inhibitor JNJ-42756493 in Subjects With Metastatic or Surgically Unresectable Urothelial Cancer With FGFR Genomic Alterations

Phase

Phase 2

Sponsor

Janssen Research & Development, LLC

Registry

Started

2015-04-22

Reported

2023

Enrolled

239 enrolled

Outcomes

In plain words

What these results mean for people, not percentages

239 enrolled

Main Study: Percentage of Participants With Best (Overall) Objective Responseprimaryresponse endpoint

21.2 vs 34.6 out of 100 had their tumour shrink with Main Study: Regimen 1: Erdafitinib 10 Milligrams (mg)/ 12 mg compared with Main Study: Regimen 2: Erdafitinib 6 mg/ 8 mg; 13.4 fewer per 100.
On this measure the first group did worse, not better.
Other groups: Main Study: Regimen 3: Erdafitinib 8 mg/ 9 mg 39.6 of 100.

A response rate counts how many people had their tumours shrink by a set amount; shrinking is encouraging but does not by itself show that people live longer or feel better.

Main Study: Overall Survivalsurvival endpoint

Median 7.5 vs 8.6 months with Main Study: Regimen 1: Erdafitinib 10 Milligrams (mg)/ 12 mg compared with Main Study: Regimen 2: Erdafitinib 6 mg/ 8 mg; about 1.2 months shorter for half the group.
A median is a midpoint: half the people did better than this and half did worse, so it is not a prediction for any one person.
Other groups: Main Study: Regimen 3: Erdafitinib 8 mg/ 9 mg 11.3 months.

Overall survival counts deaths from any cause, so it is the most direct measure of whether a treatment helps people live longer.

Main Study: Progression-free Survival (PFS)surrogate endpoint

Median 4.8 vs 5.3 months with Main Study: Regimen 1: Erdafitinib 10 Milligrams (mg)/ 12 mg compared with Main Study: Regimen 2: Erdafitinib 6 mg/ 8 mg; about 0.5 months shorter for half the group.
A median is a midpoint: half the people did better than this and half did worse, so it is not a prediction for any one person.
Other groups: Main Study: Regimen 3: Erdafitinib 8 mg/ 9 mg 5.5 months.

This is a surrogate endpoint: it measures the cancer being controlled or absent on scans and tests, which often, but not always, translates into living longer.

Caveats

These results apply to the people the trial enrolled: A Phase 2, Two-arm Multicenter, Open-Label Study to Determine the Efficacy and the Safety of Two Different Dose Regimens of a Pan-FGFR Tyrosine Kinase Inhibitor JNJ-42756493 in Subjects With Metastatic or Surgically Unresectable Urothelial Cancer With FGFR Genomic Alterations. People in a different situation may not see the same effect.
The trial selected people by a biomarker (FGFR); the result should not be assumed for people whose cancer does not have it.

Numbers are from the trial as recorded here; see the source links in the table below. This is orientation, not medical advice: ask your team how closely the trial population matches you.

239 enrolled.

Main Study: Percentage of Participants With Best (Overall) Objective Responseprimary

Main Study: Regimen 1: Erdafitinib 10 Milligrams (mg)/ 12 mg21.2 of 100

n = 33

Main Study: Regimen 2: Erdafitinib 6 mg/ 8 mg34.6 of 100

n = 78

Main Study: Regimen 3: Erdafitinib 8 mg/ 9 mg39.6 of 100

n = 101

Download

Figures from the ClinicalTrials.gov results section (first posted 2023-10-10), not from a publication

Main Study: Overall Survival

Download

range 1.7 to 64.0; Figures from the ClinicalTrials.gov results section (first posted 2023-10-10), not from a publication · range 0.4 to 60.1 · range 0.7 to 56.9

Main Study: Progression-free Survival (PFS)

Download

range 1.1 to 25.3; Figures from the ClinicalTrials.gov results section (first posted 2023-10-10), not from a publication · range 0.4 to 57.9 · range 0.0 to 51.5

Endpoint	Arm	n	Value	HR (95% CI)	p	Source
Main Study: Percentage of Participants With Best (Overall) Objective Responseprimary	Main Study: Regimen 1: Erdafitinib 10 Milligrams (mg)/ 12 mg	33	21.2%	-	-	link
	Main Study: Regimen 2: Erdafitinib 6 mg/ 8 mg	78	34.6%
	Main Study: Regimen 3: Erdafitinib 8 mg/ 9 mg	101	39.6%
Main Study: Overall Survival	Main Study: Regimen 1: Erdafitinib 10 Milligrams (mg)/ 12 mg	33	7.46 months	-	-	link
	Main Study: Regimen 2: Erdafitinib 6 mg/ 8 mg	78	8.64 months
	Main Study: Regimen 3: Erdafitinib 8 mg/ 9 mg	101	11.3 months
Main Study: Progression-free Survival (PFS)	Main Study: Regimen 1: Erdafitinib 10 Milligrams (mg)/ 12 mg	33	4.8 months	-	-	link
	Main Study: Regimen 2: Erdafitinib 6 mg/ 8 mg	78	5.26 months
	Main Study: Regimen 3: Erdafitinib 8 mg/ 9 mg	101	5.52 months

Connected

Similar pages

Trial
Study of Erdafitinib Intravesical Delivery System for Localized Bladder Cancer
Shares Erdafitinib, Johnson & Johnson, Bladder & urothelial cancer, Small-molecule kinase inhibitors and the tag pipeline.
Trial
A Study of Erdafitinib in Participants With Metastatic or Locally Advanced Urothelial Cancer
Shares Erdafitinib, Muscle-invasive and advanced bladder cancer, Johnson & Johnson, Bladder & urothelial cancer and the tag pipeline.
Trial
A Study of SI-B003 and BL-B01D1+SI-B003 in Patients With Locally Advanced or Metastatic Urothelial Carcinoma and Other Solid Tumors
Shares Muscle-invasive and advanced bladder cancer, Bladder & urothelial cancer and the tag pipeline.
Trial
A Study of BL-B01D1 + PD-1 in Patients With Locally Advanced or Metastatic Urothelial Carcinoma
Shares Muscle-invasive and advanced bladder cancer, Bladder & urothelial cancer and the tag pipeline.
Trial
A Study to Evaluate 9MW2821 Versus Chemotherapy in Subjects With Previously Treated Locally Advanced or Metastatic Urothelial Cancer
Shares Muscle-invasive and advanced bladder cancer, Bladder & urothelial cancer and the tag pipeline.
Trial
BEACON-1: Study of AVZO-103 as a Single Agent and in Combination Therapy in Patients With Locally Advanced or Metastatic Urothelial Cancer or Other Solid Tumors (AVZO-103-1001)
Shares Muscle-invasive and advanced bladder cancer, Bladder & urothelial cancer and the tag pipeline.
Trial
KEYMAKER-U04 Substudy 04D: A Clinical Study of New Treatments Given With Enfortumab Vedotin and Pembrolizumab in People With Urothelial Cancer (MK-3475-04D/KEYMAKER-U04)
Shares Muscle-invasive and advanced bladder cancer, Bladder & urothelial cancer and the tag pipeline.
Trial
A Study Comparing BL-B01D1 With Chemotherapy of Physician's Choice in Patients With Recurrent or Metastatic Urothelial Carcinoma(PANKU-Bladder01)
Shares Muscle-invasive and advanced bladder cancer, Bladder & urothelial cancer and the tag pipeline.

cancers

Bladder & urothelial cancer Muscle-invasive and advanced bladder cancer

technologies

Small-molecule kinase inhibitors

drugs

ApprovedSmall-molecule kinase inhibitor (pan-FGFR)

Erdafitinib · Balversa

companies

Johnson & Johnson