Pfizer Inc.’s lung-cancer medicine Xalkori extended the lives of patients without their disease worsening for twice as long as the standard therapies, according to a study sponsored by the New York-based drugmaker.
In a trial of 347 previously treated patients whose non-small lung cancer showed mutations in the gene known as ALK, those given Pfizer’s Xalkori experienced progression-free survival to 7.7 months, compared with 3 months for patients on the other treatments, according to results presented today at the European Society for Medical Oncology in Vienna.
The study is the first to compare Pfizer’s drug against the standard of care, the chemotherapy drug docetaxel, made by Sanofi and now available in a generic version, and Eli Lilly & Co.’s Alimta, which generated $2.46 billion in sales last year. The results suggest Xalkori should be the new standard as a second-line therapy in patients whose non-small cell lung cancer has mutations in the ALK gene, researchers said.
Xalkori’s results were “many months longer than what chemotherapy might afford,” said Alice Shaw, a doctor at Massachusetts General Hospital Cancer Center in Boston, and the study’s lead author, in a telephone interview. The drug from Pfizer, the world’s largest drugmaker, also showed improved quality of life compared with the current therapy, she said.
Shaw said the study hadn’t determined the survival benefit, because patients on the other drugs had been allowed to switch to the Pfizer medicine during the trial.
“This makes determination of overall survival benefit very difficult,” she said in a statement. It may take as much as a year before researchers on the study, which is continuing, can report that data.
Lung cancer is the top killer among malignancies in the U.S. and is expected to cause about 160,000 deaths this year, according to the National Cancer Institute. The Food and Drug Administration approved Xalkori last August, along with a test made by Abbott Laboratories to determine whether patients carry the mutation.
While the drug is approved as a first-line therapy for ALK-positive patients in the U.S., European regulators want more data on Xalkori as a first-line therapy and have ruled that it should be used after patients fail other drugs first.
“Most of us who work in this area feel pretty strongly that if a patient has a known, targetable target like ALK, that they should get it as a first-line therapy,” Shaw said.
While the ALK mutation is present in just five percent of non-small cell lung cancers, the most common form of the malignancy, “it’s a large absolute number,” Shaw said in the interview. Unlike other lung cancer patients, who are in their mid-60s or 70s, ALK-positive patients are about 50 years old on average and don’t have a history of smoking, she said.
Researchers still need to look at how to treat ALK-positive patients who relapse after taking Pfizer’s drug.