CHMP backs survival claim for lung cancer drug Giotrif

New data showing that Boehringer Ingelheim’s (BI) Giotrif can extend survival in some lung cancer patients should be added to the drug’s label, according to EU regulators.

The Committee for Medicinal Products for Human Use (CHMP) has agreed that labelling for Giotrif (afatinib) should be updated to reflect clinical data showing it can extend overall survival by around a year compared to conventional chemotherapy.

Giotrif competes in the market with other EGFR inhibitors such as Roche/Astellas’ Tarceva (erlotinib) and AstraZeneca’s Iressa (gefitinib), so the new survival claim will help BI promote its drug versus its rivals.

According to BI, Giotrif is the first and only treatment to demonstrate an overall survival benefit for non-small cell lung cancer (NSCLC) patients with the most common EGFR mutation, del19, compared to chemotherapy in the first-line setting.

The data comes from the LUX-3 and LUX-6 studies which also revealed significant benefits for the drug in progression-free survival (PFS) that will also be included in the new label.

NSCLC is the most common form of lung cancer, accounting for more than 85 per cent of cases, with the del19 mutation making up around half of the 10 to 15 per cent of tumours that are associated with EGFR mutations.

All the EGFR inhibitors are also facing additional competition from Clovis Oncology’s rociletinib, which has breakthrough designation in the US and could be on the market there by the end of the year.

Rociletinib is of particular interest because it seems to work in NSCLC patients whose tumours carry the T790M mutation, which stops the current EGFR inhibitors from working and so is linked with relapse, and may also have reduced side effects.

Meanwhile, the entire lung cancer market looks set to be shaken up by the arrival of new immuno-oncology drugs, including Bristol-Myers Squibb’s Opdivo (nivolumab) which was approved for NSCLC earlier this year.

BI is also in the latter stages of preparing regulatory filings for Giotrif (sold as Gilotrif in the US) in squamous cell carcinoma of the lung (SCC), a subgroup of NSCLC that involves cells lining the airways and is often associated with smoking.

Last month, the company reported data from the LUX-8 trial showing that Giotrif extended survival in these patients by around a month compared to Tarceva, from 6.8 to 7.9 months.

Giotrif was the first cancer drug to emerge from BI’s R&D push into cancer in 2006 and was joined last year by triple angiokinase inhibitor Vargatef (nintedanib), another drug for lung cancer.

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