* Delays progression of disease by 1.3 months
* Well-tolerated in those who received earlier treatment
By Ransdell Pierson and Bill Berkrot
NEW YORK, June 5 (Reuters) - Continued use of Eli Lilly and Co’s (LLY.N) lung cancer drug Alimta delayed worsening of the disease among patients who had taken an initial treatment regimen with the blockbuster medicine, according to a late-stage study.
Alimta currently has annual sales of more than $2 billion, making it Lilly’s third-biggest product, and the trial’s further validation of its use as a maintenance treatment could drive sales higher.
Alimta is already approved in combination with the chemotherapy agent cisplatin as a first-line, or initial treatment option. It is also approved as maintenance therapy, to delay disease return or progression, among patients who have initially been treated with chemotherapy.
With data from this new Paramount trial in hand, Lilly said it will ask U.S. regulators to approve Alimta as maintenance therapy for patients who received the drug as part of their initial therapy.
Cancer drugs are increasingly being tested as maintenance therapy, meaning they could be given for months or years to keep the disease at bay. Until recently patients who were stable after receiving treatment were not given other medicines until the disease began to worsen.
The 939-patient study, presented at the annual meeting of the American Society of Clinical Oncology in Chicago on Sunday, included subjects with the nonsquamous form of non-small cell lung cancer -- the most common type of lung cancer which affects an estimated 1.1 million Americans.
Patients received initial treatment with four courses of Alimta and cisplatin. Those whose disease did not return or worsen after initial treatment were divided into groups that received either Alimta as a maintenance therapy or a placebo.
The study showed that patients receiving maintenance treatment with Alimta went an average of 3.9 months without disease progression. That compared with 2.6 months for those receiving placebo.
The 1.3 month delay is in line with that typically seen for other newer treatments, said Dr. Luis Paz-Ares, chairman of oncology with Hospital Universatario Virgen del Rocio in Seville, Spain, who led the trial.
Although the 1.3 month delay might seen as negligible at first glance, Paz-Ares said it represented a 36 percent improvement over patients not receiving the Lilly medicine.
In future years, he said newer drugs will hopefully produce more impressive delays.
“We’re increasing step by step to improve overall results,” Paz-Ares said.
Patients in the Paramount study will be followed to assess how long Alimta actually prolongs life. It prolonged survival by five months in an earlier trial, among patients with the same nonsquamous form of the lung cancer, Paz-Ares said.
“The drug is well-tolerated, which is a reason many patients accept maintenance therapy,” he added.
Although there were more side effects among the Alimta group in the latest trial than those receiving placebos, they were far less burdensome than adverse events typically seen with chemotherapy.
Some 9.2 percent of patients taking the Lilly drug had serious adverse events, as measured in the laboratory, compared with 0.6 percent for those receiving placebos. The most common side effect was anemia, which affected 4.2 percent of those on Alimta, versus 0.6 percent of those getting placebos. (Reporting by Ransdell Pierson and Bill Berkrot, editing by Matthew Lewis)