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Roche moves closer to US filing for alectinib – Courtesy(PMLiVe)
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Roche Basel Switzerland

Positive data from two trials of Roche’s ALK inhibitor alectinib in lung cancer will be used to support a regulatory filing later this year, according to the company.

The studies involved patients with non-small cell lung cancer (NSCLC) whose tumours tested positive for the ALK mutation and had progressed despite treatment with Xalkori (crizotinib), the first ALK inhibitor to reach the market in 2011.

The results showed that alectinib was able to shrink tumours in around half of cases, and was particularly effective when the cancer had spread to the central nervous system, a complication seen in around half of NSCLC patients. Response rates in patients with metastases in the CNS were around 69%, said Roche.

“We plan to submit these data to the FDA this year to support alectinib as a potential new option for people whose advanced ALK-positive lung cancer progressed on crizotinib,” said Sandra Horning, Roche’s chief medical officer.

The company will be presenting further details from both the studies (NP28673 and NP28761) at the American Society of Clinical Oncology (ASCO) meeting later this month.

Alectinib was originally developed by Chugai – part of the Roche group – and was launched in Japan last year. It is one of three ALK inhibitors on the market alongside Xalkori and Novartis’ Zykadia (ceritinib), which is already available in the US and was approved in Europe earlier this month.

Xalkori has been very successful in NSCLC, with sales rising nearly 50% to approach $440m last year, but it is recognised that its efficacy starts to tail off after a few months of therapy.

Alectinib and ceritinib are being positioned in the first instance as second-line options to extend the benefits of ALK inhibition in ALK-positive NSCLC, although both Roche and Novartis are investigating their potential for first-line use in treatment-naïve patients. In Roche’s case the phase III ALEX trial is comparing first-line alectinib to crizotinib in ALK-positive patients diagnosed using a test kit developed by Roche’s diagnostics division.

NSCLC is the most common form of lung cancer – accounting for up to 90% of all the 1.6m cases diagnosed each year, with mutations in the ALK gene accounting for between 2% and 7% of NSCLC cases.



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