Anktiva gets a papillary knockback

ImmunityBio looked like it was taking a gamble when it filed its bladder cancer therapy Anktiva for papillary non-muscle invasive bladder cancer – and this hasn't paid off, with an FDA refusal to file letter disclosed on Monday. The riskiness came from the fact that the supplemental submission was based on the uncontrolled Quilt-3.032 trial; ImmunityBio’s bladder cancer rival, Johnson & Johnson, previously told ApexOnco that it had been advised by the agency to wait for randomised, controlled data before filing its candidate, TAR-200, in papillary disease. Nevertheless, ImmunityBio said it was “shocked” by “inconsistencies” in the FDA’s communications. Anktiva is already FDA-approved, alongside BCG, in BCG-unresponsive NMIBC with carcinoma in situ (CIS), with/without papillary disease. The company had been hoping to broaden this to BCG-unresponsive NMIBC with the more common, but less aggressive, papillary-only disease. Quilt-3.032’s cohort B tested Anktiva plus BCG, with a primary endpoint of 12-month disease-free rate, achieved by 58% of patients. ImmunityBio plans to request an urgent meeting with the FDA, but it might have to wait for data from the controlled Quilt-2.005 study, in BCG-naive patients, set to read out in the second half of 2026. The group’s stock fell 17% on Monday.