Dr Pant on the Background of the RAGNAR Trial in FGFR-altered Solid Tumors

Shubham Pant, MD, MBBS, associate professor, Departments of Investigational Cancer Therapeutics and Gastrointestinal Medical Oncology, Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center, discusses the background of the ongoing phase 2 RAGNAR trial (NCT04083976) evaluating the use of erdafitinib (Balversa) in patients with solid tumors harboring FGFR alterations.

Pant and colleagues presented data from the primary analysis of the RAGNAR study at the 2023 ASCO Annual Meeting, which detailed efficacy and safety results for 217 patients treated with erdafitinib. Notably, 66% of patients had FGFR fusions, and 35% had FGFR mutations. Alterations included FGFR1 (10%), FGFR2 (47%), and FGFR3(44%).

At a median follow-up of 17.9 months, the overall response rate (ORR) was 30% (95% CI, 24%-36%) in a refractory population where patients received a median of 2 prior lines of therapy, including 46% of patients who received at least 3 prior treatments,Pant begins. Notably, the ORR of 30% was beneficial compared with the ORR of 10% this specific population experienced during their respective previous lines of therapy, he explains.

The ORR with erdafitinib was not dominated by a particular tumor type; however, patients with pancreatic cancer (n = 18) achieved an ORR of 56%, and those with cholangiocarcinoma (n = 31) had an ORR of 52%, Pant says. Additionally, the disease control rate for all patients was 74%, and in patients with pancreatic cancer and cholangiocarcinoma, the disease control rate was 94% and 97%, respectively.

Erdafitinib was previously granted accelerated approval by the FDA in April 2019 for the treatment of adult patients with locally advanced or metastatic bladder cancer with an FGFR3 or FGFR2 alteration that has progressed on platinum-containing chemotherapy. RAGNAR is a tumor-agnostic, global basket trial of for patients with other solid tumors harboring FGFR1, FGFR2, FGFR3, and FGFR4 alterations, Pant concludes.