Boehringer Ingelheim has started phase III trials of a drug that could work when other targeted therapies for lung cancer have started to fail.
The German pharma company said today that it had enrolled the first patients into a pivotal phase II trial of BI 1482694 (HM61713) in patients with non-small cell lung cancer whose tumours test positive for the T790M mutation.
BI 1482694 is a new type of epidermal growth factor receptor (EGFR) inhibitor that is designed to overcome tumour resistance to first-generation drugs – such as Roche/Astellas’ $2bn-a-year Tarceva (erlotinib) and AstraZeneca’s Iressa (gefitinib), as well as Boehringer’s own second-generation drug Giotrif (afatinib).
Around 20% of patients with NSCLC have tumours that are resistant to EGFR inhibitors from the outset, and even in those who respond to this form of therapy the effects tend to be short-lived and just about all tumours eventually develop resistance within 10 to 12 months.
Second-generation EGFR inhibitors have improved matters, but ultimately succumb to resistance mutations, including T790M which accounts for around two-thirds of resistant cases. There is still therefore a desperate need for new targeted therapies that can be used when current therapies start to fail and delay the need for patients to shift over to chemotherapy.
Aside from Boehringer, other companies developing third-generation EGFR inhibitors include Clovis Oncology with twice-daily rociletinib (CO-1686) and AZ with once-daily osimertinib/AZD9291, both of which are further ahead in development.
Clinical data on both rociletinib and osimertinib was reported earlier this year and showed them to be better tolerated than the first-generation drugs while offering response rates of around 60% with progression-free survival of around 10 months.
Boehringer is mindful of the ned to play catch up and has announced an aggressive timeline for its candidate, saying it hopes to have its first approval in 2017.
“We are investing strongly in our lung cancer pipeline, and together with the oncology community we aim to develop better treatment options for these patients,” said Dr Mehdi Shahidi, Boehringer’s head of solid tumour oncology.
“The initiation of the first pivotal trial of BI 1482694 is an important milestone in the forthcoming broad clinical trial programme, including several phase III trials,” he added.