Janssen Submits Prospectus Highlighting Pan-Cancer Efficacy of FGFR Inhibitor Balversa Across 14 Tumor Types

Recently, Janssen, a subsidiary of Johnson & Johnson, announced preliminary results from its pivotal Phase 2 clinical trial, RAGNAR, at the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting. This trial evaluates the efficacy of its FGFR kinase inhibitor Balversa (erdafitinib) in patients with advanced solid tumors harboring specific FGFR mutations. The pre-specified interim analysis (IA) showed that patients with various types of FGFR-driven mutations responded to Balversa even after receiving multiple standard treatments.

RANGER Trial is a Phase 2 clinical trial designed to analyze the efficacy and safety of Balversa in patients with advanced or metastatic solid tumors harboring specific FGFR gene mutations. This treatment is tumor-agnostic, meaning it does not differentiate based on tumor location or histological morphology. The interim analysis is based on results from 178 patients with 32 different histological tumor types. The most common tumor types included cholangiocarcinoma (n=31), high-grade glioma (brain or spinal cord tumors) (n=29), breast cancer (n=14), pancreatic cancer (n=13), and squamous non-small cell lung cancer (n=11). The trial also included rare tumors such as salivary gland and parathyroid cancers (which are uncommon endocrine tumors), as well as cancers of unknown primary origin. Participants in the trial had undergone extensive prior treatments, with 74.7% (n=133) having received two or more lines of therapy.

The primary endpoint of RANGNAR's clinical trial was the overall response rate (ORR) assessed by an Independent Review Committee (IRC). As of the interim analysis cutoff date, the IRC-evaluated ORR in the overall patient population was 29.2% (95% CI: 22.7-36.5), and the disease control rate (DCR) was 72.5% (95% CI: 65.3-78.9). Researchers observed effectiveness across 14 different types of tumors, including salivary gland cancer (100% ORR, n=5 participants with n=5 responders), pancreatic cancer (31% ORR, n=29 participants with n=6 responders), and glioblastoma (21% ORR, n=29 participants with n=6 responders), which are difficult-to-treat cancers. Researchers also reported a median duration of response (DOR) of 7.1 months (95% CI: 5.5-9.3). At the data cutoff date, 51.1% (n=24) of patients who had responded continued to show a response.

The safety profile of Balversa observed in the RAGNAR trial was consistent with the known profile of Balversa in metastatic urothelial carcinoma (mUC). Grade 3 or higher adverse events were reported in 44.9% of patients across various tumor types. These adverse events can be managed with supportive care and dose interruptions or reductions, if necessary. The discontinuation rate due to drug-related adverse events was 7.3%.

"Advancements in FGFR gene mutation diagnostics have opened up tumor-agnostic targeted therapies for patients," said Dr. Yohann Loriot, the principal investigator of the trial. "The results of the RAGNAR trial indicate that by targeting and inhibiting FGFR receptors, we may be able to provide more appropriate treatment for patients with advanced FGFR-driven tumors, regardless of their tumor location or histological type."

In 2019, Balversa was granted accelerated approval by the U.S. FDA for use in patients with locally advanced or metastatic urothelial carcinoma harboring susceptible FGFR2 or FGFR3 mutations, whose disease progressed during or after at least one prior line of platinum-containing chemotherapy.

References:

[1] Janssen Presents Initial Results from the Phase 2 RAGNAR Study of BALVERSA (erdafitinib) in Patients with Advanced Solid Tumors with FGFR Alterations. Retrieved June 7, 2022, from https://www.jnj.com/janssen-presents-initial-results-from-the-phase-2-ragnar-study-of-Balversa-erdafitinib-in-patients-with-advanced-solid-tumors-with-fgfr-alterations

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