MONALEESA-2: Updated results confirm benefit of ribociclib addition
medwireNews: A second interim analysis of the MONALEESA-2 trial indicates that the addition of ribociclib to letrozole remains beneficial for patients with hormone receptor-positive, HER2-negative advanced breast cancer over longer follow-up.
The previous analysis – conducted at a median follow-up of 15.3 months – showed a significant progression-free survival (PFS) gain among the 334 treatment-naïve participants who received the CDK 4/6 inhibitor ribociclib alongside letrozole for recurrent or metastatic disease relative to the 334 patients given placebo plus letrozole.
This gain is maintained with longer follow-up, say Gabriel Hortobagyi (The University of Texas MD Anderson Cancer Center, Houston, USA) and co-investigators, with corresponding median PFS times of 25.3 and 16.0 months at a median follow-up of 26.4 months, giving a significant hazard ratio in favor of ribociclib of 0.568.
Furthermore, they note that safety findings “were comparable with those reported at the first analysis, with no new or unexpected toxicities observed, and no evidence of cumulative toxicity.”
“Ribociclib and endocrine therapy combinations are being further investigated in ongoing phase III trials” in this patient population, the researchers conclude in the Annals of Oncology.
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