FGFR inhibitors demonstrate efficacy in 14 cancer types
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FGFR inhibitors demonstrate efficacy in 14 cancer types.
Janssen, a Johnson & Johnson company, announced preliminary results of its pivotal Phase 2 clinical trial RAGNAR at the 2022 American Society of Clinical Oncology (ASCO) annual meeting.
This trial evaluates its FGFR kinase inhibitor, Balversa (erdafitinib), in patients with advanced solid tumors with specific FGFR mutations.
A scheduled interim analysis (IA) showed that patients with solid tumors with different types of FGFR driver mutations responded to Balversa even after a series of standard treatments.
The 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 with specific FGFR gene mutations, regardless of tumor type, i.e. tumor location or histology .
The interim analysis was based on results from 178 patients with tumors of 32 different histologies. The most common tumor types were biliary tract cancer (n=31), high-grade glioma (brain or spinal cord tumor) (n=29), breast cancer (n=14), pancreatic cancer (n=13) and squamous cell carcinoma (n=14). non-small cell lung cancer (n=11).
The trial also included tumors that are less common in the real world, such as salivary gland and parathyroid cancers, which are rare endocrine tumors, and cancers of unknown primary origin.
Participants in the trial were heavily pretreated, and 74.7% (n=133) of patients had received 2 or more lines of therapy.
The clinical trial endpoint of RANGNAR was the overall response rate (ORR) as assessed by an independent review committee (IRC). At the cutoff date of the interim analysis, the IRC-assessed ORR was 29.2% (95% CI, 22.7-36.5) and the disease control rate (DCR) was 72.5% (95% CI, 65.3-78.9) in the overall patient population.
The researchers found effects on 14 different types of tumors. These included salivary gland cancer (100% ORR, n=5 subjects, n=5 responders), pancreatic cancer (31% ORR, n=29 subjects, n=6 responders), Plasmoblastoma (21% ORR, n=29 subjects, n=6 responders), a difficult-to-treat cancer.
The researchers also observed an overall 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 a remission response continued to have a response.
The safety profile of Balversa observed in the RAGNAR trial was consistent with what was previously known for Balversa in metastatic urothelial carcinoma (mUC).
Adverse reactions of grade 3 or higher occurred in 44.9% of patients across different tumor types.
These adverse reactions can be managed with supportive care and discontinuation or reduction of treatment when necessary. The rate of trial discontinuation due to drug-induced adverse reactions was 7.3%.
“Advances in the diagnosis of FGFR gene mutations have opened the door for patients to target therapies that do not differentiate between tumor types,” said Dr. Yohann Loriot, principal investigator of the trial. “The results of the RAGNAR trial show that by targeting the FGFR receptor, we may be able to It can provide a more appropriate treatment for patients with advanced FGFR-driven tumors, regardless of tumor location and histology.”
In 2019, Balversa received accelerated approval by the U.S. Food and Drug Administration for patients with metastatic urothelial carcinoma in advanced in situ or with underlying FGFR2 or FGFR3 mutations that developed during or after at least one 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
FGFR inhibitors demonstrate efficacy in 14 cancer types
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