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Boehringer lung cancer drug shows survival benefit

pharmafile | June 3, 2014 | News story | Sales and Marketing ASCO, Boehringer, NSCLC, afatinib, giotrif, lung cancer 

A new analysis of two late-stage trials shows that Boehringer drug Giotrif extends overall survival in a large proportion of non-small cell lung cancer (NSCLC) patients.

Participants with commonly observed cell receptor mutations lived around three months longer when treated immediately after diagnosis with Giotrif (afatanib) compared to standard chemotherapy.

However, a more specific group of patients who displayed the exon 19 deletion mutation, and constituted about half of those studied, lived for up to 11 months longer on Giotrif – a death risk reduction of more than 40 per cent.

“This has never been shown before in this group of patients,” says lead researcher James Yang of the National Taiwan University Hospital, adding that he and his team do not yet know why these participants responded so well to the treatment.

The new analysis was presented at this year’s American Society of Clinical Oncologists (ASCO) meeting in Chicago, the world’s top cancer research event.

Giotrif is already approved in a number of territories, including the US and Europe for the treatment of NSCLC. The drug has previously been found to extend progression-free survival – the amount of time that a therapy keeps its target disease in check.

Displaying an improvement in overall survival, however, is a major achievement in cancer research. But lung cancer specialist and ASCO associate Greg Masters preaches caution over the new analysis.

He suggests the data are promising but draws attention to Giotrif’s side effects profile, of which diarrhoea is a particularly prominent factor.

“[Giotrif] is going to have a place in the treatment landscape because, as we do better in defining our targets, it is one of the drugs that has produced some positive data,” he tells Pharmafile.

“But whether that translates clinically into a significant improvement for patients, especially with the potential for more toxicity is something we have to weigh up. I think it’s a little bit early to say whether it will bring a huge advantage over what we have now.”

Nevertheless, an improvement in overall survival in this particular subgroup of patients may give the drug an edge over competitors. Other established drugs used in a similar, first-line NSCLC setting include Tarceva (erlotinib, Roche) and Iressa (gefitinib, AstraZeneca).

Giotrif became Boehringer’s first ever approved cancer drug last year when it won over regulators in the US and Europe. Analysts at BioMedTracker predict it will hit peak annual sales of $1.8 billion by 2018.

Boehringer Ingelheim covered Pharmafocus’s travel and accommodation costs for ASCO 2014.

Hugh McCafferty

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