Tuesday, July 16, 2024

Erdafitinib Gains Positive CHMP Opinion for Urothelial Carcinoma

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Janssen-Cilag International NV, a Johnson & Johnson company, has announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended marketing authorization for BALVERSA® (erdafitinib) as a once-daily oral monotherapy for adult patients with unresectable or metastatic urothelial carcinoma (UC) with susceptible FGFR3 genetic alterations. Erdafitinib is the first targeted therapy to receive a positive CHMP recommendation for this patient population, marking a significant advancement in the treatment of urothelial carcinoma.

The CHMP’s recommendation is based on results from Cohort 1 of the Phase 3 THOR study, which demonstrated a 36 percent reduction in the risk of death with erdafitinib compared to chemotherapy. The study evaluated 136 patients with advanced or metastatic UC and FGFR alterations who had progressed on or after one or two prior treatments, including a PD-1 or PD-L1 inhibitor. The results showed a median overall survival of 12.1 months for patients treated with erdafitinib, compared to 7.8 months for those receiving chemotherapy.

Erdafitinib also showed an improvement in median progression-free survival (PFS) compared to chemotherapy, with 5.6 months versus 2.7 months, respectively. The overall response rate (ORR) for erdafitinib was 35.3 percent, significantly higher than the 8.5 percent observed with chemotherapy. These findings highlight erdafitinib’s potential as a valuable treatment option for patients with FGFR3-altered urothelial carcinoma.

Safety data from the THOR study indicated that serious treatment-related adverse events (TRAEs) were observed in 13.3 percent of patients treated with erdafitinib, compared to 24.1 percent in the chemotherapy group. Grade 3 or higher adverse events occurred in 45.9 percent of patients on erdafitinib and 46.4 percent on chemotherapy. TRAEs leading to discontinuation of therapy were reported in 8.1 percent of erdafitinib-treated patients, versus 13.4 percent of those on chemotherapy.

The positive CHMP opinion is a crucial step toward improving outcomes for patients with bladder cancer harboring FGFR alterations. Dr. Henar Hevia, Senior Director, EMEA Therapeutic Area Lead, Oncology, Johnson & Johnson Innovative Medicine, emphasized the need for a multidisciplinary care team approach to identify patients who could benefit from erdafitinib through biomarker testing. This approach ensures that the right treatment reaches the right patient at the right time.

Urothelial Carcinoma

Erdafitinib: A New Hope for Urothelial Carcinoma

Bladder cancer is a significant health concern in Europe, with nearly 225,000 new cases diagnosed in 2022, representing a 10 percent increase from 2020. The most common form of bladder cancer is urothelial carcinoma, and up to 20 percent of patients with metastatic UC have FGFR alterations. Prognosis remains poor for these patients, with only 8 percent surviving for five years or more when diagnosed at a late metastatic stage.

Dr. Kiran Patel, Vice President, Clinical Development, Solid Tumours, Johnson & Johnson Innovative Medicine, noted that erdafitinib represents an important new therapeutic option for patients with FGFR3-altered urothelial carcinoma. The THOR study results underscore the potential of erdafitinib to significantly improve patient outcomes and reinforce Johnson & Johnson’s commitment to advancing precision medicine in oncology.

The THOR study is a Phase 3 randomized, open-label, multicenter trial evaluating the efficacy and safety of erdafitinib. It includes two cohorts: one comparing erdafitinib to standard chemotherapy (docetaxel or vinflunine) after at least one line of treatment, including a PD-1 or PD-L1 inhibitor, and the other comparing erdafitinib to pembrolizumab after one prior treatment not containing a PD-1 or PD-L1 inhibitor. The primary endpoint is overall survival, with secondary endpoints including progression-free survival, overall response rate, duration of response, patient-reported outcomes, safety, and pharmacokinetics.

Erdafitinib is a pan-fibroblast growth factor receptor (FGFR) tyrosine kinase inhibitor. It has shown promise in clinical trials for patients with advanced urothelial cancer. The THOR study, along with other ongoing studies, supports the potential of erdafitinib as a transformative therapy for patients with FGFR-driven cancers. Erdafitinib’s approval by the FDA in January 2024 for the treatment of adult patients with locally advanced or metastatic UC with FGFR3 genetic alterations further underscores its significance in cancer treatment.

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Bladder cancer, specifically urothelial carcinoma, starts in the bladder’s inner lining and accounts for over 90 percent of bladder cancer cases. FGFR alterations are present in up to 20 percent of metastatic UC cases and are associated with adverse clinical outcomes. Testing for FGFR mutations and fusions can identify patients eligible for FGFR-targeted therapies, such as erdafitinib. Early molecular and genomic testing is recommended to facilitate timely treatment decisions and improve patient outcomes.


Resource: Johnson & Johnson, June 28, 2024

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