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).

Selected studies of anti-PD-(L)1 MAbs in breast cancer
Study Treatment Setting Trial ID Results
Keynote-119 Keytruda 2nd/3rd-line NCT02555657 May 2019: failed
Impassion-130 Tecentriq + chemo 1st-line NCT02425891 Mar 2019: US approval in PD-L1+ve patients
Keynote-355 Keytruda + chemo 1st-line NCT02819518 Dec 2019
Keynote-522 Keytruda + chemo Neoadjuvant NCT03036488 Jul 2019 (8mth delay): +ve for pCR
Impassion-031 Tecentriq + chemo Neoadjuvant NCT03197935 Sep 2020 (18mth delay)
MO39875  Tecentriq + chemo Neoadjuvant NCT03281954 Dec 2023
Impassion-030 Tecentriq + chemo Adjuvant NCT03498716 Jan 2022
Keynote-242 Keytruda Adjuvant NCT02954874 May 2026

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