Immunomedics confirms its approval within three months

It is common for trials seeking to confirm an accelerated approval either to fail – with no regulatory comeback – or to be consigned to the industry scrapheap, never to read out. So the success Immunomedics scored yesterday must be seen as a double triumph. Not only has Ascent, its confirmatory trial backing Trodelvy, read out less than three months after US approval, the data are so stellar that they could give reps detailing the drug a real advantage when speaking to doctors. Trodelvy, an antibody-drug conjugate against the Trop2 antigen, was approved for third-line triple-negative breast cancer on the strength of remission rates in the single-cohort phase II IMMU-132-01 trial. Ascent, a controlled phase III study in a similar population, had been halted early for efficacy in April, and yesterday Immunomedics toplined its primary endpoint of progression-free survival, saying risk of progression was cut by 59%. Overall survival was also increased with Trodelvy, though the data are being held back for scientific presentation. Armed with survival data on its label Trodelvy looks better placed than before to meet its 2026 revenue forecast of $2.3bn, according to EvaluatePharma sellside consensus, and attention turns to studies in earlier treatment settings.

Selected Trodelvy studies in breast cancer
Trial Setting Result?
IMMU-132-01 ≥3L TNBC single cohort 33% ORR
Ascent ≥3L TNBC vs chemo mPFS 5.6mth vs 1.7mth (HR=0.41, p<0.0001)
Tropics-02 ≥3L HR+/Her2- breast cancer vs chemo Nov 2021
Morpheus-TNBC 1L TNBC, includes Tecentriq combo May 2023
Seastar Rubraca combo, includes TNBC Oct 2023

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