Cancer is the fastest-growing sector of the drugs industry, yet the market for treating some tumors is shrinking.
The paradox reflects the arrival of “personalized medicine” — or treatment tailored to the genetic make-up of individual patients — and it poses a big challenge to drug makers aiming to make money in a crowded and fragmented market.
“As we increasingly sub-divide tumors by their molecular type, it is going to get harder and harder to develop drugs and make a profit out of it,” said Mark Verrill, a senior oncologist at Newcastle General Hospital in the north of England.
The issue will be thrown into the spotlight this week at the European Society for Medical Oncology congress in Berlin as makers of two rival drugs jostle to prove their benefits in a subset of patients with colorectal cancer.
Erbitux, which was discovered by ImClone, now part of Eli Lilly, and is sold by Merck KGaA and Bristol-Myers Squibb, currently dominates the so-called anti-EGFR market. It had sales last year of US$1.6 billion — 10 times more than Amgen’s Vectibix.
But Amgen hopes to redress this imbalance by showing its drug is similarly effective, while offering dosing advantages.
Both drugs have recently been found to work only in the 65 percent of patients whose tumors contain the normal, or wild-type, version of a gene known as KRAS.
The case reflects a tough decision companies now have to make in developing cancer medicines: Does it make sense to accept a smaller market if a drug is more likely to help those treated?
The upside lies in the fact that patients will take a drug for longer if it works, and governments and insurers may be more willing to pay. The downside is the loss of wider sales — in the case of Erbitux and Vectibix, 35 percent of the expected market has effectively disappeared.
Elmar Schnee, head of German Merck’s pharmaceuticals unit, said developing cancer drugs in this new era was proving “more difficult than initially thought,” and that companies had to study genetic sub-groups right from the start of clinical tests.
“It’s fair to assume that the number of clinical trials will rise, because there will be more sub-groups, but there should be a higher chance of success,” he said. “We have to find a way, together with regulators, to control the costs of the expensive studies that are required at the moment. There is no way that we can finance full Phase III programs for three sub-groups.”
Regulators are certainly paying a lot of attention to the issue, with the European Medicines Agency taking a lead role.
The watchdog was the first to require KRAS tests in colorectal cancer and it also recently cleared AstraZeneca’s Iressa for the 10 percent to 15 percent of lung cancer patients in Europe with a specific gene mutation that makes them susceptible to the drug. Iressa was launched in Germany in July.
The agency’s executive director, Thomas Lonngren, is a strong believer in using genetic tests, or biomarkers.
“This area will see quite rapid development in the coming years and will probably completely change the way that medicines are given to people,” he said. “It could improve the rational use of medicine. It could improve the effectiveness of drug treatment dramatically.”
Cancer drugs are already the biggest category of drugs by sales, with global revenues of US$48.2 billion last year and an annual growth rate of 11.3 percent, more than twice the overall industry average, according to research firm IMS Health.
With hundreds of new drugs in development, cancer is a top priority for drugmakers including Pfizer, AstraZeneca, Roche, Novartis, GlaxoSmithKline and Sanofi-Aventis, all of whom are busy incorporating diagnostic biomarkers into their drug trials.
Translating the complex messages from genetic assays into clinical practice is not always easy.
Research published this week found up to two-thirds of patients with aggressive breast cancer were not tested for the HER2 gene to see if they should get Herceptin, while one in five of those who were may have had incorrect results.
Roche’s Herceptin, which has annual sales of nearly US$5 billion, was the first of the new generation of targeted cancer drugs linked to a biomarker test, or “companion diagnostic.”
“There are huge issues around quality control of the companion diagnostics,” Verrill said. “It’s not like testing if the lights are on or off. It’s generally a question of a threshold having to be reached and there is a spectrum of positivity for any of these tests.”
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