Boehringer submits new lung cancer drug
pharmafile | September 20, 2012 | News story | Research and Development, Sales and Marketing | Boehringer, NSCLC, Roche, Tarceva, afatinib
Boehringer Ingelheim has filed its new lung cancer drug with the EMA.
Afatinib is the latest targeted therapy for lung cancer, which will add to the treatment choices in the hard-to-treat therapy area.
Boehringer says its Phase III LUX-Lung trials suggest afatinib is superior to best-in-class chemotherapy (pemetrexed and cisplatin).
Afatinib will also challenge Roche’s blockbuster oral treatment Tarceva. Like Tarceva, the new drug is a tyrosine kinase inhibitor that targets the EGFR receptor, which plays a key role in many lung cancers.
But afatinib represents an advance over its ‘first generation’ EGFR rival in that it blocks a wider range of targets, and is the first irreversible blocker.
In non-squamous NSCLC, the drug showed superiority in patients with stage IIIb or IV adenocarcinoma of the lung harbouring an EGFR mutation. Patients taking afatinib as a first line treatment lived for almost one year without their tumour growing (progression-free survival (PFS) of 11.1 months) versus just over half a year (PFS of 6.9 months) for those on chemotherapy (pemetrexed/cisplatin).
These results also give afatinib a slight edge over Tarceva, which produced 9.7 months of PFS in a comparable study.
However, trials suggest the drug produces severe side effects more commonly than Tarceva and other ‘first generation’ EGFR inhibitors.
Nevertheless, the drug could also be given to patients who develop a ‘resistance’ to the first generation EGFR blockers, and Boehringer conducted earlier stage trials addressing this question.
The company has also built in quality of life measures into its LUX-Lung trial. A standard questionnaire of patients found those taking the treatment had a better quality of life, including activities at work and at home.
Boehringer say the drug has shown ‘unprecedented efficacy’ versus chemotherapy in the trial.
“With so many people being diagnosed with, and dying from lung cancer, there is still a clear need for effective and tolerable therapies. Boehringer Ingelheim is committed to helping patients have access to afatinib as soon as possible,” said Prof Klaus Dugi, corporate senior vice president Medicine, Boehringer Ingelheim.
“The positive clinical evidence for afatinib, coupled with its novel mode of action, could make this an outstanding treatment option, providing much needed benefits for lung cancer patients.”
Boehringer has also found promising signs that the drug might provide stronger benefits to particular sub-groups of patients. NSCLC patients with tumours harbouring the two most common EGFR mutations (del19 and L858R, accounting for 90% of all tumours with EGFR mutations) taking afatinib lived for well over a year without disease progression (PFS of 13.6 months), versus just over half a year (PFS of 6.9 months) for those in the comparator arm.
The delay in disease progression for afatinib-treated patients was associated with an improvement of life-restricting lung cancer symptoms. More patients taking afatinib experienced an improvement in dyspnoea (shortness of breath), cough, and chest pain. Afatinib also significantly delayed the deterioration of these symptoms compared to chemotherapy.
Further data from the trial, including symptom improvement and health-related quality of life results, will be presented at the ESMO 2012 Congress (European Society for Medical Oncology) Vienna, Austria which begins on 28 September.
Andrew McConaghie
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