Therapy Areas: Central Nervous System
Seagen Presents Updated Results from Pivotal HER2CLIMB Trial Evaluating Tukysa in Patients with HER2-Positive Breast Cancer with Brain Metastases
10 December 2021 - - US-based biotechnology company Seagen Inc. (NASDAQ: SGEN) has presented new data from exploratory analyses from the pivotal HER2CLIMB trial showing that improvement in overall survival was maintained after an additional 15.6 months of follow-up when Tukysa (tucatinib) was combined with trastuzumab and capecitabine in patients with HER2-positive metastatic breast cancer who had stable or active brain metastases.

The data were featured in a spotlight poster (Abstract #PD4-04) at the 2021 San Antonio Breast Cancer Symposium (SABCS).

After a median follow-up of 29.6 months, the Tukysa regimen improved OS for patients with brain metastases by 9.1 months compared to trastuzumab and capecitabine alone (21.6 months vs. 12.5 months) (HR: 0.60; [95% CI: 0.44, 0.81]).

The benefit extended to patients with active or stable brain metastases.

Tukysa treatment continued to show clinically meaningful benefit in progression-free survival in the central nervous system (CNS-PFS), representing a delay of cancer progression in the brain.

The rates for intracranial objective response rate (ORR-IC) and duration of objective response (DOR-IC) were consistent with previous analyses.

HER2CLIMB is a multinational randomized, double-blind, placebo-controlled, active comparator, pivotal clinical trial comparing Tukysa in combination with trastuzumab and capecitabine compared with trastuzumab and capecitabine alone in patients with locally advanced unresectable or metastatic HER2-positive breast cancer who were previously treated with trastuzumab, pertuzumab and T-DM1.

The primary endpoint of the trial was PFS per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 as determined by blinded independent central review in the first 480 patients enrolled in the trial.

HER2CLIMB enrolled a total of 612 patients to support the analyses of key secondary endpoints, including overall survival, PFS per BICR in patients with brain metastases at baseline and confirmed objective response rate. Safety data were evaluated throughout the study.

Tukysa is an oral medicine that is a tyrosine kinase inhibitor of the HER2 protein.

In vitro (in lab studies), Tukysa inhibited phosphorylation of HER2 and HER3, resulting in inhibition of downstream MAPK and AKT signaling and cell growth (proliferation), and showed anti-tumor activity in HER2-expressing tumor cells.

In vivo (in living organisms), Tukysa inhibited the growth of HER2-expressing tumors.

The combination of Tukysa and the anti-HER2 antibody trastuzumab showed increased anti-tumor activity in vitro and in vivo compared to either medicine alone.

Tukysa is approved in 36 countries. It was approved by the US FDA in April 2020 and by the European Medicines Agency and the UK Medicines and Healthcare Products Regulatory Agency in February 2021.

US-based Merck (NYSE: MRK), known as MSD outside the US and Canada, has exclusive rights to commercialize Tukysa in Asia, the Middle East and Latin America and other regions outside of the US, Canada and Europe.

Tukysa is indicated in combination with trastuzumab and capecitabine for treatment of adult patients with advanced unresectable or metastatic HER2-positive breast cancer, including patients with brain metastases, who have received one or more prior anti-HER2-based regimens in the metastatic setting.


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