Roche, looking to regain lost ground in immuno-oncology, probably did not need Merck & Co to challenge it on its home turf of breast cancer. But it looks like this has happened with today’s hit for Keytruda in the Keynote-355 study in first-line triple-negative disease. Still, the victory is equivocal, Keynote-355 extending progression-free survival only in ≥10% PD-L1 expressers. The study presumably failed in all-comers and in the ≥1% population, while its co-primary endpoint of overall survival has yet to be revealed. Roche’s Tecentriq, in combination with Abraxane, already carries a first-line TNBC label in ≥1% PD-L1 expressers thanks to the Impassion-130 trial, so perhaps the Keytruda threat does not yet amount to much. But Keytruda might also steal a march on Tecentriq in perioperative TNBC use, thanks to the separate Keynote-522 study, whose positive result stands in contrast to Tecentriq’s recently failed NeoTRIPaPDL1 neoadjuvant trial (Perioperative use proves elusive for Tecentriq, February 10, 2020). And Keytruda earlier flunked the second-line TNBC study Keynote-119 in all-comers, so today’s news suggests that Roche cannot afford to rest on its laurels.
|Merck vs Roche in triple-negative breast cancer|
|Impassion-130||Tecentriq + Abraxane||1st-line||Hit on mPFS in ≥1% PD-L1; US & EU approved|
|Keynote-119||Keytruda monotherapy||2nd/3rd-line||Fail; exploratory OS hit in ≥20% PD-L1|
|Keynote-355||Keytruda + chemo||1st-line||Hit on mPFS in ≥10% PD-L1|
|Keynote-522||Keytruda + chemo||Neoadj + adjuvant||Hit on pCR, 13.6-point improvement, p=0.00055|
|NeoTRIPaPDL1||Tecentriq + chemo||Neoadjuvant||Miss on pCR|
|Impassion-031||Tecentriq + Abraxane||Neoadjuvant||Upsized by 120 subjects; data late 2020|