Balversa, a once-daily, oral FGFR kinase inhibitor, met the primary endpoint of overall survival (OS) and reduced the risk of death by 36% in a Phase 3 randomised, open-label, multi-centre study
Balversa is a once-daily, oral FGFR kinase inhibitor. (Credit: Nappy on Unsplash)
The Janssen Pharmaceutical Companies of Johnson & Johnson has announced that Balversa (erdafitinib) met its primary endpoint in an interim analysis of Cohort 1 of the Phase 3 THOR study of patients with metastatic or unresectable urothelial carcinoma (UC).
Balversa is a once-daily, oral FGFR kinase inhibitor, approved by the US Food and Drug Administration (FDA).
The Phase 3 THOR study evaluated treatment with Balversa versus chemotherapy in UC patients and selected fibroblast growth factor receptor (FGFR) gene alterations who had received prior treatment with an anti-programmed death ligand 1 (PD-[L]1) agent.
As per the findings, the study met its primary endpoint of overall survival (OS) and reduced the risk of death by 36%.
THOR is a Phase 3 randomised, open-label, multicentre study with the goal to assess the efficacy and safety of Balversa. The patients who received prior treatment with an anti-PD-(L)1 agent were categorised in Cohort 1 and patients with prior treatment without any anti-PD-(L)1 agent were described as Cohort 2.
In Cohort 1, patients were randomised to get either Balversa or chemotherapy in a 1:1 ratio and patients in Cohort 2 were randomised to receive either Balversa or pembrolizumab in a 1:1 ratio.
Janssen said that the primary endpoint of the study is OS whereas progression-free survival (PFS), objective response rate (ORR), duration of response (DOR), patient-reported outcomes, safety and pharmacokinetics (PK) were secondary endpoints.
Study principal investigator Yohann Loriot said: “These results represent the first data from a randomised, controlled trial evaluating Balversa for the treatment of patients with FGFR-altered urothelial carcinoma, who often experience poor disease outcomes.
“The use of Balversa in this setting supports recommendations for FGFR testing in all patients with metastatic urothelial cancer.”
In addition, Janssen reported longer-term data for TECVAYLI (teclistamab-cqyv) showing a duration of response of 22 months in patients with relapsed or refractory multiple myeloma.
The findings demonstrated that nearly half of the patients achieved a complete response (CR) or better in the Phase 1/2 MajesTEC-1 study along with an overall response rate (ORR) of 63%.
In a separate development, the pharmaceutical firm announced that Carvykti (ciltacabtagene autoleucel) reduces the risk of disease progression or death by 74% in earlier-line multiple myeloma treatment in Phase 3 CARTITUDE-4 study.
At 16-month median follow-up, Carvykti was found to significantly enhance progression-free survival compared to two standard treatments.