— “Clear pattern” for enhanced progression-free survival in subgroup with brain metastases too
by
Greg LaubDirector, Video, MedPage Today
December 22, 2023
Findings from the stage III HER2CLIMB-02 trial provided at the San Antonio Breast Cancer Symposium revealed that the addition of tucatinib (Tukysa) to trastuzumab emtansine (T-DM1, Kadcyla) extended progression-free survival (PFS) versus T-DM1 alone for formerly dealt with clients with unresectable in your area sophisticated or metastatic HER2-positive breast cancer, consisting of a favorable pattern in those with brain metastases.
In this special MedPage Today video, private investigator Sara A. Hurvitz, MD, of the Fred Hutchinson Cancer Center in Seattle, talks about outcomes of the double HER2-targeted technique.
Following is a records of her remarks:
HER2CLIMB-02 was a stage III randomized, placebo-controlled scientific trial examining whether tucatinib includes advantage when contributed to T-DM1. There have to do with 460 clients arbitrarily appointed to T-DM1 plus tucatinib or T-DM1 plus placebo. Clients were qualified if they had actually formerly gotten trastuzumab [Herceptin] and a taxane in any setting.
Surprisingly, clients with brain mets [metastases] were enabled on this research study, and 44% of clients registered had brain mets, half of whom had active brain mets.
The research study showed at the main analysis that progression-free survival was considerably enhanced with the addition of tucatinib to T-DM1 by about 2 months with a threat ratio of 0.76. There was a hierarchical screening style, so since the main endpoint was favorable we then evaluated total survival at this very first interim analysis. Which was not yet favorable. The information are immature, there are just 53% of occasions taped at this time, so we’ll be following total survival long-lasting.
Progression-free survival in the population of clients with brain mets likewise revealed an extremely clear pattern for enhancement with tucatinib, not officially checked since of that hierarchical style. Total tucatinib actually did appear to enhance results for clients, waiting on the general survival proof.
From an adverse effects profile, including tucatinib to T-DM1 does increase the rate of grade 3 or higher occasions and treatment discontinuations. Especially, there are more grade 3 or higher transaminase elevations. There are greater rates of diarrhea and throwing up. Keeping an eye on clients carefully if this program is authorized in the future will be essential. These were reversible occasions with discontinuation or treatment holds.