By Peter Loftus
(Updated to include four additional studies at the bottom.)
Eli Lilly & Co.'s /zigman2/quotes/200106384/composite LLY +0.98% Alimta delayed growth in lung cancer when used soon after initial chemotherapy, a new study concluded.
The study could support broader use of Alimta, which had $854 million in sales last year, up 40% from 2006. Leerink Swann analyst Seamus Fernandez estimated Thursday the data - together with newly approved uses - could lead to higher Alimta sales than his current forecast of $1.7 billion in 2012.
The study involving the most deadly form of cancer was among nearly 5,000 studies published online Thursday night by the American Society of Clinical Oncology. Under a new policy, ASCO publicly released brief abstracts of the studies two weeks before the start of its annual meeting in Chicago on May 30, where full results will be presented before thousands of cancer doctors.
The new ASCO policy was intended to avoid the stock trading on non-public information that was believed to have occurred under a prior policy in which ASCO mailed out abstracts under embargo weeks before its annual meetings.
The data released Thursday night, however, don't include several eagerly awaited studies that are being held by ASCO until the meeting itself. These include studies of ImClone Systems Inc.'s Erbitux in lung cancer and colorectal cancer, and Genentech Inc.'s /zigman2/quotes/226092395/composite DNA +0.51% Avastin and Novartis AG's /zigman2/quotes/203243705/composite NVS +0.48% Zometa in breast cancer.
Bristol-Myers Squibb Co. /zigman2/quotes/202559280/composite BMY +0.13% and Merck KGAA market Erbitux and pay royalties to ImClone. Genentech is majority-owned by Roche Holding AG /zigman2/quotes/208994986/composite RHHBY +1.08% , which also markets Avastin outside the U.S.
The blizzard of new studies underscores increased research efforts by drug makers to broaden their respective shares of a global cancer-drug market that IMS Health Inc. predicted Thursday would nearly double to between $75 billion and $80 billion by 2012, from an estimated $41 billion last year.
The Food and Drug Administration approved Alimta in 2004 as a second-line treatment of locally advanced or metastatic non-small cell lung cancer after prior chemotherapy. Non-small cell lung cancer is the most common form of lung cancer. The drug also is approved for use in asbestos-related cancer.
Lilly has said Alimta is the worldwide market leader in second-line treatment of non-small cell lung cancer, but it isn't yet widely used earlier in the treatment cycle. Other drugs such as carboplatin and paclitaxel are common treatments for previously untreated patients.
But Alimta could make inroads into earlier stages of treatment. In April, European health authorities approved Alimta as a first-line treatment of non-small cell lung cancer with certain tissue types. The Indianapolis drug maker also has applied for U.S. approval of Alimta in the first-line setting, but the FDA hasn't yet decided on the application.
Normally, lung cancer patients who complete first-line treatment stop therapy until new tumor growth, when they begin a second-line treatment such as Alimta. The latest Alimta study, however, suggests the drug could be useful in a so-called "maintenance" phase - a few weeks after first-line chemotherapy but before any new tumor growth that would trigger second-line treatment.
"This is the first study to show that lung cancer patients can benefit from maintenance therapy," Tudor-Eliade Ciuleanu, an oncologist in Romania and the study's lead author, said in a press release issued by ASCO Thursday.
In the Lilly-funded study of about 663 patients whose disease hadn't progressed after four cycles of platinum-based chemotherapy, those taking Alimta had progression-free survival of 4.3 months, compared with 2.6 months among those not taking Alimta. Progression-free survival is the time from start of treatment until the disease gets worse, but not a measure of whether a drug prolongs life.
It is still unclear whether Alimta given as a maintenance therapy can actually help lung-cancer patients live longer. Preliminary data showed that overall survival was extended to 13 months among all Alimta users, versus 10.2 months in the placebo group. But the study is ongoing, and final overall survival data won't be known for several months.