NEW YORK (Reuters) - The use of Eli Lilly and Co’s Alimta following successful chemotherapy treatment helped patients with advanced lung cancer live significantly longer, according to data released on Saturday.
The study, presented at the American Society of Clinical Oncology (ASCO) meeting in Orlando, Florida, also confirmed that the benefit from Alimta is primarily limited to the more common nonsquamous type of non-small cell lung cancer.
Patients in the study with that type of cancer who were treated with Alimta as a so-called maintenance therapy lived more than five months longer than those who got a placebo.
“This should become the standard of care,” Dr. Chandra Belani, deputy director of the Penn State Cancer Institute and the study’s lead investigator, said in an interview.
“This is the first time that there is a benefit of five months in nonsquamous patients. As the cumulative toxicity is minimal it can be given for a prolonged duration of time,” Belani said.
Alimta, known chemically as pemetrexed, is approved for use in combination with chemotherapy as an initial treatment for advanced nonsquamous non-small cell lung cancer. Approval as a maintenance therapy — to delay worsening of the disease after chemotherapy has stalled tumor growth — would add a lucrative new revenue source for the medicine.
Alimta had sales of $1.15 billion in 2008.
“This is the next step in the overall management (of the disease),” Belani said.
“If you can give it for a prolonged duration of time you then can change the acute nature of the disease to a chronic disease. That’s the intent, that you can maintain that state of response with the initial chemotherapy,” Belani explained.
Preliminary results from the 663-patient, late-stage study presented at last year’s ASCO meeting demonstrated Alimta’s ability to delay disease progression when used as a maintenance therapy. The latest data for the first time showed a significant improvement in overall survival, researchers said.
Overall survival — the extension of a patient’s life — is considered the gold standard by physicians and by health regulators making approval decisions.
All patients in the study had advanced or metastatic non-small cell lung cancer that had not progressed after four cycles of platinum-based chemotherapy.
In the overall patient population, those who received Alimta lived for an average of 13.4 months versus 10.6 months for patients in the placebo group. Among patients with the nonsquamous type of cancer, those who got Alimta lived an average of 15.5 months compared with 10.3 months in the placebo group. Both results were considered to be statistically significant, Belani said.
The lack of benefit among patients with the squamous subtype confirmed what had been seen in prior Alimta studies.
Side effects more common in the Alimta group were fatigue and low white blood cell counts, researchers said. There were no drug-related deaths in the study.
Reporting by Bill Berkrot, editing by Dave Zimmerman