Bladder no-go, but Trodelvy has bigger problems

Friday’s withdrawal of Trodelvy’s accelerated US approval for third-line bladder cancer is a setback, but compared with the drug’s struggles to make headway in other settings it pales into relative insignificance. Bladder cancer was a relatively small source of revenue for the Gilead drug, acquired through the $21bn takeover of Immunomedics, and withdrawal was on the cards as soon as the confirmatory Tropics-04 study was declared a bust in May; no data from Tropics-04 have been released, but in the trial Trodelvy failed to beat chemo alone on overall survival. Far more important is breast cancer, where Trodelvy is being squeezed by Daiichi Sankyo/AstraZeneca’s Enhertu, and threatened by datopotamab deruxtecan (the latter faces its own problems, however), and NSCLC. In the latter setting Gilead had played up a “clinically meaningful” subgroup benefit in the Evoke-01 trial, but full data at ASCO revealed this to be illusory, and a promised US filing never materialised. At the last mention of Evoke-01, during August’s second-quarter earnings call, Gilead admitted: “We have discussed the results of Evoke-01 ... with regulators, and as expected have confirmed there is no immediate regulatory path based on Evoke-01 alone."