Astra drug keeps lung cancer from worsening-study
* Progression-free survival 17.3 wks vs 14 wks
* FDA filing expected by June 30
* No progress with biomarkers
By Deena Beasley
ORLANDO, Fla., May 30 (Reuters) - AstraZeneca PLC's (AZN.L: Quote, Profile, Research) Zactima, which failed two earlier trials, was shown in a pivotal study to extend the amount of time patients survived without their lung cancer worsening, researchers said on Saturday.
The trial, called Zodiac, involved 1,391 patients with advanced non-small cell lung cancer. It also found that almost twice as many patients treated with a combination of Zactima and chemotherapy drug docetaxel had shrinkage of their tumors, compared with those given just chemotherapy.
Median "progression-free" survival for the group on the combination therapy was 17.3 weeks, compared with 14 weeks for the chemotherapy-alone patients, according to the study, which was presented here at the annual meeting of the American Society of Clinical Oncology.
The results also showed "a trend toward advantage in overall survival," in patients who were "quite sick, quite symptomatic," said Peter Langmuir, medical science director at AstraZeneca.
He said the company plans to file for U.S. regulatory approval of the oral drug, also known as vandetanib, by the end of June.
Like Roche Holding AG's (ROG.VX: Quote, Profile, Research) Avastin, Zactima is designed to block the vascular endothelial growth factor, which tumors need to develop a blood supply. The Astra drug also targets the vascular epidermal growth factor receptor, the same protein blocked by drugs like Tarceva, a product of Roche and OSI Pharmaceuticals Inc (OSIP.O: Quote, Profile, Research).
AstraZeneca said efforts to determine which patient groups were most likely to respond to its drug have so far had little success.
Langmuir said Zactima adds rash and diarrhea to the list of side effects seen from chemotherapy, but patients have less nausea, vomiting and anemia.
"The fact that more patients had an improvement in the symptoms from their lung cancer suggests that the drug could be important for the future management of this disease," Dr. Roy Herbst, chief of thoracic medical oncology at the University of Texas M.D. Anderson Cancer Center and the study's lead author, said in a statement.
Results from a fourth trial, studying Zactima as a stand-alone treatment after the use of Tarceva and other drugs, are expected later this year.
Lung cancer kills 1.2 million people a year and is the top cause of cancer death globally. Many drugs are used to treat it but they almost always stop working eventually.
Langmuir said Astra is currently exploring a number of development options for Zactima as a first-line lung cancer therapy and in maintenance settings. (Reporting by Deena Beasley, editing by Matthew Lewis)
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