Tecentriq reasserts its breast cancer position

If Tecentriq’s breakthrough in first-line triple-negative breast cancer ultimately ended up somewhat muted, Roche now has a chance to reassert its authority. This is courtesy of the neoadjuvant Impassion-031 study, which today read out positively for pathological complete response. Tecentriq plus Abraxane is approved for first-line TNBC, but only in patients expressing PD-L1 at 1% or greater, as a result of the Impassion-130 trial, whose marginal all-comers benefit disappointed (Tecentriq gets its narrow breast cancer label, March 11, 2019). However, Impassion-030, in which Tecentriq plus Abraxane-containing chemo was given before surgery, has shown a benefit versus chemo alone regardless of PD-L1 expression, Roche says. The full data, including the extent to which PD-L1 expressers drive the overall benefit, have yet to be scrutinised, but Impassion-031 might allow Roche to establish Tecentriq as a standard in an all-comers setting, ie before that of Impassion-131, which would accordingly become less important. This could also neutralise the threat of Merck & Co’s Keytruda, whose TNBC successes comprise the front-line Keynote-355 trial, albeit in ≥10% PD-L1 expressers, and Keynote-522, a neoadjuvant/adjuvant study. And Tecentriq’s failure in another neoadjuvant trial, NeoTRIPaPDL1, now becomes easier to dismiss.