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Boehringer releases positive results from two breast cancer trials of afatinib

Germany-based Boehringer Ingelheim has reported positive results from two trials (LUX-Breast 1 and LUX-Breast 3) evaluating afatinib to treat patients with breast cancer.

The Phase III LUX-Breast 1 trial compared afatinib plus vinorelbine (experimental arm) with trastuzumab plus vinorelbine in patients with HER2-positive metastatic breast cancer after failure of prior trastuzumab-based therapy.

In both treatment arms, the trial showed similar progression-free survival and objective response, but shorter overall survival in the experimental arm.

Diarrhoea, neutropenia and rash were the most common adverse events observed with afatinib plus vinorelbine and neutropenia, leukopenia and anaemia were observed in patients taking reported with trastuzumab plus vinorelbine.

According to the company, the combination of afatinib plus vinorelbine was less tolerable with a higher rate of dose reductions and treatment discontinuations compared to trastuzumab plus vinorelbine.

Patient enrolment in the trial was closed in April 2013, following the recommendation of the independent Data Monitoring Committee (DMC).

Based on the results, the company discontinued recruitment into all trials investigating afatinib plus vinorelbine in HER2-positive metastatic breast cancer.

LUX-Breast 3 is a randomized, open-label Phase II trial in patients with HER2-positive breast cancer progressing with brain metastases.

This three-armed trial compared afatinib, afatinib plus vinorelbine and investigator’s choice of therapy, after prior trastuzumab and/or lapatinib-based therapy.

Results from LUX-Breast 3 trial, showed no benefit for afatinib-containing regimens over treatments selected by the physician as measured by the primary endpoint of patient benefit at 12 weeks and secondary endpoints including progression-free survival and overall survival.