Boehringer Ingelheim has said it will abandon two trials of Gilotrif in head and neck cancer after disappointing data.
Gilotrif (afatinib) has been on the market for EGFR-positive non-small cell lung cancer (NSCLC) for some time, and was recently approved for a second indication – advanced squamous cell carcinoma of the lung – in the US and Europe.
The product has been a successful drug for the German drugmaker, marking the firm’s entry into the oncology sector with its launch in 2013.
However, Boehringer’s hopes of extending its use into head and neck cancer have now been undermined by the data monitoring committee for the global LUX-Head & Neck 2 and 4 trials, which concluded it was “highly unlikely” that a benefit would be seen for the drug.
The two trials were comparing afatinib with in patients with locally advanced head and neck cancer who have no evidence of disease after treatment with chemotherapy and radiotherapy. Boehringer hoped that afatinib would prolong the period before the cancer returned in these patients.
Boehringer has not completely abandoned hope of a head and neck cancer indication for the drug, however. The company has already reported one positive study in patients with recurrent and/or metastatic head and neck cancer (LUX-Head and Neck 1) while another in Asian patients (LUX-Head and Neck 3) is continuing on the recommendation of its data monitoring committee.
Nevertheless, the disappointing data in locally-advanced head and neck cancer is a blow to Boehringer’s hopes to expanding sales of the drug, particularly as it is now facing increased competition in the EGFR inhibitor sector.
It is already vying in the marketplace against AstraZeneca’s Iressa (gefitinib) and Roche/Astellas’ Tarceva (erlotinib) in first-line NSCLC, and looks likely to face increased pressure with the availability of third-generation inhibitors such as AZ’s Tagrisso (osimertinib).
Currently approved for second-line treatment, AZ recently presented data supporting the use of Tagrisso as a first-line NSCLC treatment.