Nexavar fails in lung cancer trial
pharmafile | June 15, 2010 | News story | Research and Development | Bayer, NSCLC, Nexavar, Onyx
Bayer and Onyx Pharmaceutical’s oncology drug Nexavar has failed to meet its primary endpoint in a phase III study for non-small cell lung cancer.
The drug, which already has several oncology indications, was being trialed as a first-line oral treatment in patients with advanced, non-squamous, non-small cell lung cancer (NSCLC).
It failed to meet its primary endpoint of increasing overall survival in the first-line setting in the NExUS trial, which was a randomised, double-blind, placebo-controlled study in treatment-naïve patients in combination with other chemotherapies.
Dr Dimitris Voliotis, VP of global clinical development oncology at Bayer, said: “Bayer and Onyx are disappointed with these results, in particular, for patients who are suffering from this deadly disease.”
Voliotis continued: “We are confident with our comprehensive clinical trial programme exploring Nexavar’s potential in a variety of tumor types, including lung cancer. Based on encouraging data from the recently presented prospective biomarker data and phase II signal-generating lung cancer studies, we believe it’s critical to continue our evaluation of Nexavar in combination with targeted agents and as a monotherapy in later lines of treatment in lung cancer patients.”
Nexavar is being evaluated by Bayer/Onyx for a variety of treatment settings for patients with NSCLC, including a phase III monotherapy study in the third- and fourth-line setting. It is also in phase II studies, in combination with other therapies, to evaluate the drug in a second-line setting.
Bayer and Onyx have said that they will further review the findings of this analysis to determine what impact these data may have on other ongoing clinical trials evaluating the safety and efficacy of Nexavar.
The drug is currently in trials for breast cancer and approved in Europe for the treatment of hepatocelluar carcinoma (a type of liver cancer) and for advanced renal cell carcinoma (advanced kidney cancer).
In May Nexavar was rejected by NICE for advanced renal cell carcinoma after the the cost-effectiveness body deemed it too expensive.
Nexavar’s latest trial results follow a spate of letdowns in NSCLC that include trial failures for Antisoma’s ASA404 candidate and Merck’s cancer vaccine.
Meanwhile, in March this year Pfizer’s figitumumab failed in phase III studies and the FDA rejected Adventrx’s vinorelbine after the company failed to supply the regulatory body with enough data.
Roche and OSI Pharma’s Tarceva remains the current standard of care for patients with NSCLC who are stable after receiving chemotherapy and last year the drug achieved sales of $1.2 billion.
Ben Adams
Related Content
Evotec and Bayer announce new kidney disease study
Evotec and Bayer have announced the initiation of a phase 2 clinical study in kidney …
Third application for Orion’s prostate cancer drug submitted by partner Bayer
Finnish pharmaceutical company Orion has announced that its partner Bayer is applying for a third application …
iOnctura expands clinical trial programme for NSCLC
iOnctura has announced the expansion of its clinical trial programme for its lead pipeline asset, …
