Latin American cancer vax races Big Pharma rivals

The lung cancer vaccine race has brought together an unusual mix of players. Merck KGaA was in a good position, but its vaccine disappointed in Phase III, while GlaxoSmithKline ($GSK) could report data on its candidate this year. Then there is the Cuba-Argentina joint venture.

A snippet of data from the Latin American cancer vaccine project was reported in the Financial Times this week. In a 1,700 person trial, 24% of patients on the vaccine--called Racotumomab--were alive after two years, compared to 8% on chemotherapy and radiotherapy. Phase III trials are continuing in 7 countries. Success in these studies could see the vaccine improve the outlook for people with a form of cancer that killed 1.7 million people in 2008.

"Of course, this is not a miracle cure. But it does provide an option so that, in combination with chemotherapy and radiotherapy, it can prolong survival significantly," Daniel Alonso, a veteran of the 18-year cancer vaccine project, told the Financial Times. The most effective role for the vaccine appears to be in prolonging the lives of patients whose tumors have been shrunk, but not eliminated, by chemotherapy or radiotherapy. Patients were given 5 doses, each two weeks apart, followed by monthly maintenance shots. This regime reportedly costs $20,000.

Argentine group Insud paid 60% of the $100 million development cost, with Cuba contributing the rest. The developers are targeting approval in Asia, Latin America and Europe, but believe reaching the U.S. market could be problematic. While most drugs just need to win over the FDA, the lung cancer vaccine will need authorization from the Office of Foreign Assets Control because of the U.S. embargo against Cuba. This has precedent though. In 1999 SmithKline Beecham--now part of GSK--was allowed to license a meningitis B vaccine, and in 2004 CancerVax was cleared to develop three Cuban cancer drugs.

The goal is to have the vaccine on sale in 25 countries by 2015, but it could face competition. GSK may present late-stage data for its lung cancer vaccine MAGE-A3 this year, while Merck KGaA is considering continuing development of its candidate. The Merck vaccine--previously known as Stimuvax--disappointed in Phase III trials in December, but last month data showed it prolonged the lives of some patients by an average of 10 months.

- here's the FT article (sub. req.)