Boehringer puts afatinib head-to-head with Herceptin

pharmafile | December 10, 2010 | News story | Research and Development |  BIBW 2992, Boehringer Ingelheim, Herceptin, Roche, Tovok, afatinib, breast cancer 

Boehringer Ingelheim has set up a showdown between one of its pipeline oncology products and Roche’s Herceptin.

It has started an open-label, randomised phase III trial in the US to see whether afatinib (BIBW 2992, whose planned brand name is Tovok) offers better progression-free survival (PFS) in breast cancer.

The LUX-Breast 1 trial will take patients with metastatic breast cancer after prior treatment with Herceptin (trastuzumab) who have an over-expression of the human epidermal receptor 2 protein.

HER2-positive breast cancer is particularly aggressive and is associated with a greater risk of disease progression and death compared to women with HER2-negative tumours.

The primary endpoint of this trial is to see whether afatinib provides longer PFS than continuing treatment with Herceptin, when both are added to the standard chemotherapy treatment vinorelbine.

Secondary endpoints are overall survival and safety. Afatinib is an oral inhibitor of the epidermal growth factor receptor (EGFR) and HER2 tyrosine kinases.

Research suggests that in approximately 30% of advanced breast cancer cases, women overexpress the HER2 protein.

“Based on results from our proof of concept studies for afatinib in breast cancer, we are pleased to advance this programme into a pivotal phase III trial,” said Christopher Corsico, Boehringer’s US medical director. 

The decision was based on phase II data in advanced HER2-positive breast cancer patients whose cancer had progressed following treatment with Herceptin. Cutaneous adverse events and diaorrhea were the most common side effects.

The LUX trial programme comprises more than ten trials worldwide, investigating afatinib in solid tumour types such as non-small cell lung cancer (NSCLC) and head and neck cancer.

Boehringer has made no secret of its wish to broaden its oncology activities beyond these therapy areas.

Breast cancer is the second-biggest cause of cancer death in women after lung cancer, with more than 39,840 women in the US expected to die from it this year.

Adam Hill