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Pfizer says Xalkori tops chemo as first line therapy

Superior progression free survival for lung cancer patients

Pfizer Xalkori (crizotinib) 

Pfizer's lung cancer drug Xalkori is more effective than conventional chemotherapy when given as a first-line treatment, according to the results of a new trial.

The pharma company claims Xalkori (crizotinib) is the first drug to show superior progression-free survival (PFS) compared to platinum-based chemotherapy in previously-untreated non-small cell lung cancer (NSCLC) patients whose tumours test positive for the ALK gene.

Xalkori is already approved as a second-line treatment after chemotherapy for ALK-positive NSCLC patients, who make up around 5 per cent of the total NSCLC population and typically comprise younger patients and non-smokers. It was granted conditional approval by the FDA in 2011, which was updated to a full registration last year, and was approved in Europe in 2012.

The drug is one of the fastest-growing in Pfizer's pipeline, pulling in sales of $282m last year, which was more than double its turnover in 2012. Adding a first-line indication to the drug's labelling could add further momentum to its growth trajectory, providing Pfizer can encourage use of its ALK companion diagnostic.

"These data … highlight the importance of not only testing a tissue specimen for the presence of biomarkers at the time of diagnosis in all patients with advanced stage NSCLC, but actually having those results in hand before determining the most appropriate treatment option for each patient," commented Tony Mok, professor of clinical oncology at the Chinese University of Hong Kong.

Xalkori sits alongside Inlyta (axitinib) and Bosulif (bosutinib) among a stable of new cancer drugs the company expects to drive sales growth in the coming years, with analysts predicting peak sales of the drug could top $2bn. However, Pfizer's oncology pipeline suffered a blow earlier this year after another NSCLC candidate - pan-HER kinase inhibitor dacomitinib - failed a phase III trial.

"A multidisciplinary collaborative approach to molecular testing is required in order to deliver those results on time," he added.

At the moment Pfizer has the ALK-positive market to itself, although it is facing competition in future from a number of other ALK-targeting compounds, including candidates from Novartis (LDK378), Roche/Chugai (alectinib; RG7853) and Ariad (AP26113) in late-stage development.

Pfizer is also evaluating Xalkori in a trial comparing the drug with Lilly's Alimta (pemetrexed) plus cisplatin or carboplatin in patients previously untreated for ALK-positive advanced NSCLC.

Article by
Phil Taylor

26th March 2014

From: Research

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