Targeted bladder cancer treatment evolves
Last week’s restriction of the US approval for Johnson & Johnson’s Balversa reflects clinical reality as well as the evolving treatment landscape for the indication in question, urothelial bladder cancer. The FGFR inhibitor was first approved, on an accelerated basis, in 2019 in second-line patients with FGFR2 or FGFR3 genetic alterations, even though its supporting clinical trial had shown a 0% response rate in the FGFR2 subgroup. Back then immunotherapy had only made inroads into the second-line setting, and it wasn’t until 2020 that Merck KGaA’s Bavencio started carving out its niche in first-line bladder cancer maintenance. Now things have progressed further, with Merck/Pfizer’s Keytruda plus Padcev combo scoring a front-line label, and Bristol Myers Squibb gunning for a similar nod with an Opdivo plus chemo combo. The developments explain the FDA’s action on 19 January: the agency granted Balversa full approval, but only in FGFR3-altered disease, and only in patients who aren't eligible for PD-(L)1 blockade.
Selected Balversa studies
| Trial | Setting | Data | Relevance |
|---|---|---|---|
| BLC2001 | ≥2L, various mutations | 32% ORR; 41% ORR in FGFR3 mutation, 11% ORR in FGFR3 fusion, 0% ORR in FGFR2 fusion | Backed Apr 2019 accelerated approval for 2L FGFR3 or FGFR2 altered urothelial carcinoma |
| Thor | ≥2L, FGFR3-altered, post PD-(L)1 | mOS 12.1mth vs 7.8mth for chemo (HR=0.64, p=0.0050) | Backs Jan 2024 full approval for 2L FGFR3 altered, PD-(L)1-ineligible urothelial carcinoma |
Source: prescribing information.
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