Subgroup analysis of nelipepimut-S plus GM-CSF combined with trastuzumab versus trastuzumab alone to prevent recurrences in patients with high-risk, HER2 low-expressing breast cancer.
Clinical immunology (Orlando, Fla.)
Breast cancer; Cancer vaccine; Immunotherapy; Personalized medicine; providence southern california; santa monica; SJHMC
HER2-targeted therapy has not benefited patients with low levels of HER2 expression; however, combination therapy may be effective. Primary analysis of a phase IIb trial investigating the HER2-derived vaccine nelipepimut-S (NPS) did not benefit the intention-to-treat population, but subset analysis showed a benefit in triple-negative breast cancer (TNBC) patients. The subset analysis of this multicenter, randomized, single-blind, phase IIb trial identified significant improvement in 36-month disease-free survival (DFS) between NPS (n = 55) and placebo (n = 44) in TNBC (HR 0.25, p = 0.01) and those who express HLA-A24 (HR 0.41, p = 0.05). The TNBC cohort demonstrated improved 36-month DFS in those with HER2 1+ expression (HR 0.17, p = 0.01), HLA-A24 positivity (HR 0.08, p < 0.01), or in those who received neoadjuvant chemotherapy (HR 0.21, p < 0.01). NPS vaccination with trastuzumab was associated with improved 36-month DFS among patients with TNBC. The observed benefit to this high-risk subgroup warrants confirmation in a phase III trial.
Chick, R Connor; Clifton, G Travis; Hale, Diane F; Vreeland, Timothy J; Hickerson, Annelies T; Kemp Bohan, Phillip M; McCarthy, Patrick M; Litton, Jennifer K; Alatrash, Gheath; Murthy, Rashmi K; Qiao, Na; Philips, Anne; Lukas, Jason; Holmes, Jarrod P; Mittendorf, Elizabeth A; and Peoples, George E, "Subgroup analysis of nelipepimut-S plus GM-CSF combined with trastuzumab versus trastuzumab alone to prevent recurrences in patients with high-risk, HER2 low-expressing breast cancer." (2021). Articles, Abstracts, and Reports. 4276.