Merck salvages some pride in breast cancer

Two months after Keytruda failed in second-line triple-negative breast cancer Merck has scored a win in the disease’s neoadjuvant setting. In an interim analysis of the delayed Keynote-522 trial the drug plus chemo beat chemo alone in terms of pathological complete response, Merck said yesterday; the study’s second co-primary measure, event-free survival, has yet to read out. How much the neoadjuvant setting is worth is unclear, however: Evercore ISI had earlier said it could amount to an extra $1.2bn of peak revenue, but Mizuho analysts wrote yesterday that neoadjuvant was a “small opportunity”. EvaluatePharma sees breast cancer as a whole comprising just $231m of Keytruda’s 2024 revenue. Keytruda’s main checkpoint MAb competitor here could be Roche’s Tecentriq, which scored a US first-line PD-L1-positive TNBC label in March, and which was recently recommended for EU approval in this setting. In neoadjuvant use, however, readout of Tecentriq’s Impassion-131 trial has been delayed from March 2019 to September 2020. It had also been suggested that Keynote-522 could open up some adjuvant TNBC use; trials specifically in this much bigger setting are ongoing (Keytruda’s chance to take on Tecentriq in breast cancer, November 7, 2018).