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.

Roche trials in triple-negative breast cancer
Study Design Primary endpoint(s) Result
Impassion-031 Tecentriq + Abraxane vs Abraxane pCR in PD-L1+ and all-comers Toplined positive in PD-L1+ and all-comers
Neoadjuvant + adjuvant
NeoTRIPaPDL1  Tecentriq + Abraxane vs Abraxane EFS Failed in Dec 2019
MO39875 Tecentriq + chemo vs chemo pCR & EFS Dec 2023 primary completion
Impassion-030 Tecentriq + chemo vs chemo iDFS Jan 2022 primary completion
Impassion-130 Tecentriq + Abraxane vs Abraxane OS & PFS in PD-L1+ and all-comers Approved in ≥1% PD-L1
Impassion-131 Tecentriq + paclitaxel vs paclitaxel PFS in PD-L1+ and all-comers Upsized by 11%, completion delayed from Feb to Nov 2019; still no data
Impassion-132 Tecentriq + chemo vs chemo OS in PD-L1+ and all-comers Upsized by 63%, completion delayed from Jul 2019 to Jan 2023
Ipatunity-130 Ipatasertib + chemo vs chemo PFS in PIK3CA/AKT1/PTEN-altered Dec 2021 primary completion
Source: clinicaltrials.gov & company presentation.

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