Posted on 06/09/2023 8:30:36 PM PDT by ConservativeMind
Three clinical trials demonstrated positive results from the targeted therapy erdafitinib for patients with multiple tumor types harboring FGFR alterations.
Erdafitinib blocks activity of FGFR signaling proteins.
The tumor-agnostic Phase II RAGNAR trial confirmed the efficacy of erdafitinib in heavily pre-treated patients with advanced FGFR-altered solid tumors across 16 distinct cancer types.
The overall response rate (ORR) was 29.5%, including six complete responses and 58 partial responses. The ORR was comparable across FGFR1-3 mutations and fusions. The treatment achieved a disease control rate of 73.7% and a clinical benefit rate of 45.6%, including an ORR of 56% in patients with pancreatic cancer and 52% in cholangiocarcinoma.
The Phase II NORSE study demonstrated clinically meaningful improvements when adding the immunotherapy cetrelimab to erdafitinib for patients with FGFR-altered metastatic urothelial, or urinary tract, cancers.
The combination of erdafitinib with cetrelimab achieved an ORR of 54.5% across 44 patients, with six complete responses (CRs) and an overall survival (OS) rate of 68% at 12 months. In comparison, erdafitinib alone achieved an ORR of 44.2% in 43 patients, including one CR and a 12-month OS rate of 56%.
“FGFR-altered tumors typically are immunologically cold and have limited responses to immunotherapy.”
According to results from cohort one of the Phase III THOR trial, erdafitinib significantly improved survival and response outcomes relative to standard chemotherapy for patients with advanced or metastatic urothelial cancers with FGFR alterations.
With patients randomized to receive either erdafitinib or chemotherapy, the median OS was 12.1 and 7.8 months, respectively, corresponding to a 36% lower risk of death for those treated with erdafitinib. Further, erdafitinib achieved a median progression-free survival of 5.6 months compared to just 2.7 months for chemotherapy. Nearly half (46%) of patients treated with erdafitinib saw tumors shrink, while just 12% on the chemotherapy arm had an objective response.
(Excerpt) Read more at medicalxpress.com ...
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