Boehringer Ingelheim announced a positive opinion from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) for the company’s product Giotrif (afatinib) for the treatment of advanced squamous cell carcinoma (SqCC) of the lung.
Giotrif is already approved in more than 60 countries for the treatment of EGFR (epidermal growth factor receptor) mutated non-small cell lung cancer (NSCLC), and the now-published positive opinion is an important step toward approval for squamous cell carcinoma that has progressed while or after patients were on platinum-based chemotherapy.
The recommended approval is based on the results of the LUX-lung 8 clinical trial, which is part of a larger collection of clinical studies evaluating the drug in centers across the world — the afatinib LUX-Lung program.
According to the American Cancer Society, from 25 percent to 30 percent of all lung cancers are squamous cell carcinomas, which is a subtype of NSCLC. This type of cancer develops in the flat cells that line the inside or the airways in the lungs, and is generally associated with a poor prognosis.
Giotrif (afatinib) is a tyrosine kinase inhibitor (TKI) that blocks EGFR, delaying or stopping the growth of EGFR-positive cancers, which account for 10 percent to 15 percent of NSCLCs.
The Lux-lung 8 trial (NCT01523587), which is still ongoing, aims to compare the efficacy between afatinib and erlotinib (an approved therapy) in the treatment of patients with advanced squamous cell carcinoma of the lung requiring second-line treatment after receiving first-line platinum-based chemotherapy.
A total of 795 patients were enrolled in the trial and randomly distributed through either an experimental group receiving afatinib or the group receiving the active comparator erlotinib.
When compared to the erlotinib group, the patients receiving afatinib treatment demonstrated a significant delay in lung cancer progression, by 19 percent. The risk of death was also reduced by 19 percent, with a significant improvement in overall survival. Moreover, the results demonstrated an improvement in quality of life and control of cancer symptoms.
In terms of safety, the rate of adverse events was similar in both groups. However, both reported a higher incidence of different sets of symptoms: severe diarrhea and stomatitis (mouth sores) for afatinib, and severe rash or acne for erlotinib.
“Despite recent advances in the treatment of squamous cell lung cancer, this disease remains challenging to treat,” said Dr. Mehdi Shahidi, medical head of Solid Tumor Oncology at Boehringer Ingelheim in a press release. “We are pleased to receive this positive opinion from the CHMP for afatinib. Not only does it represent the potential availability of the first oral treatment option specifically approved for patients with squamous cell lung cancer, it also confirms the positive profile of afatinib, a second-generation EGFR targeting agent, when compared to a first-generation agent.”