Anktiva gets its papillary date with destiny

ImmunityBio has persevered with Anktiva in a new use, BCG-unresponsive papillary non-muscle invasive bladder cancer, and now an FDA decision is due by 6 January 2027. A big question is whether the agency will grant approval based on the Quilt-3.032 trial – the uncontrolled nature of which was apparently behind a refuse-to-file letter last year. The company hasn’t carried out a new study, and seems to be relying on data detailing the overlap between papillary disease and carcinoma in situ, where Anktiva has been approved since 2024. ImmunityBio reasoned that “CIS and papillary disease arise from the same cancer inducing clone [and] is therefore the same disease biologically”. Papillary-only disease is more common but less aggressive than CIS and, according to another bladder cancer player, Johnson & Johnson, the FDA has advised waiting for randomised data in the papillary population with that group’s product, Inlexzo. J&J is testing Inlexzo in post-BCG papillary-only disease in the controlled Sunrise-5 study, yielding data this year. Meanwhile, ImmunityBio has a controlled trial, Quilt-2.005, reading out in 2026; however, that’s in BCG-naive CIS patients. Elsewhere, the FDA’s tolerance of uncontrolled data is also being tested by Pierre Fabre and Atara’s Ebvallo.

An Anktiva timeline

Source: OncologyPipeline.