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By Denise Roland
Seeking an edge in the increasingly competitive market for cancer drugs, one of the industry's largest companies is taking a bold but risky approach: targeting the early stages of the disease.
AstraZeneca PLC's new cancer research chief, José Baselga, wants the company to prioritize early-stage cancers over advanced disease when developing new cancer drugs. If successful, his unorthodox strategy could reap rewards for both patients -- the potential to cure cancer is much greater when it is treated early -- and company coffers.
The approach turns the tried-and-tested model of cancer drug development on its head. Typically, drug companies aim their new cancer drugs at patients with advanced forms of the disease who have exhausted other treatment options. Of the more than 30 new drugs for solid tumors approved for sale in the U.S. since the start of 2014, just two targeted early cancer.
That is largely because there is a clear-cut case for testing new drugs on patients with advanced cancer, as they don't have other options. What's more, measuring a new medicine's effect in advanced cancer is straightforward: a meaningful extension in survival can usually be measured in months. Such patients are also often more willing to try experimental drugs, and regulators have smoothed the path for treatments that show they can prolong lives by delaying tumor growth in advanced cancer.
AstraZeneca will still carry out initial testing in advanced-stage patients to establish the safety of brand new cancer drugs. But Dr. Baselga, who joined AstraZeneca earlier this year, wants drugs that clear that hurdle to be developed for early-stage patients first.
Dr. Baselga said in an interview that he was challenging AstraZeneca's researchers to come up with a plan to develop "every single new compound" first and foremost for early-stage cancer. AstraZeneca will later this year start trials for early-stage breast cancer with DS-8201, a drug it is codeveloping with Japan's Daiichi Sankyo Co., he said.
Analysts say the approach has potential but would face big hurdles. "It's not impossible," said Citi analyst Andrew Baum. "But it would involve a major change in paradigm outside of breast cancer," which is one area where companies have made some progress in developing drugs for early-stage disease.
Dr. Baselga's strategy builds on a sharpened focus on cancer at AstraZeneca in recent years aimed at reviving the company after a series of patent expirations on best-selling drugs like cholesterol pill Crestor knocked billions of dollars off the company's annual sales over the past decade.
AstraZeneca isn't alone in investing heavily in cancer medicine. Rivals including Pfizer Inc. and Merck & Co. are also pushing into the disease, spurred by scientific breakthroughs, a permissive regulatory environment and the promise of high returns. Between 2007 and 2017, the number of cancer drugs in late-stage clinical trials surged more than 60% to 710, according to IQVIA, a health-care data provider.
Targeting early-stage cancer could give AstraZeneca an edge. The potential market is large, especially in tumor types where the majority of patients are diagnosed at an early stage, such as breast and prostate. Around two-thirds of breast-cancer patients are diagnosed when their disease is at an early stage, according to the National Cancer Institute.
Dr. Baselga -- a prominent breast cancer doctor -- said it is getting easier to prioritize early cancer due to better ways of identifying which patients are at higher risk of their tumors returning and the rise of drugs that can more accurately target tumor cells, reducing potential side effects. Dr. Baselga was previously chief medical officer at Memorial Sloan Kettering Cancer Center before stepping down last year after his failure to disclose payments from the drug industry in some academic journal articles. He says those omissions were inadvertent.
"We need to spend our resources on those places where we can cure more people and that's in early disease," he said. "It's a deep philosophical belief that we have."
Still, the path to prioritizing early cancer could be thorny.
When cancer is caught early, the tumor is usually removed or killed using a mix of surgery, chemotherapy and radiation therapy. In some patients, this already constitutes a cure. That creates a high bar for any new drug, which would have to prove it significantly reduced the chances of the tumor returning.
"One thing with early stage disease, you have to be able to cure patients," said Daniel Chen, who spent more than a decade running cancer drug development projects at Roche Holding AG. "The majority of cancer drugs delay cancer growth, they don't cure patients." Dr. Chen is now chief medical officer at biotech start up IGM Biosciences Inc.
Running clinical trials could also be difficult, as it would involve persuading patients to try experimental drugs when they might already be cured.
Another challenge is measuring the drug's effectiveness. In patients whose cancer is diagnosed and treated early, it would take years to determine whether a new drug meaningfully extended survival, making for very long clinical trials.
Dr. Baselga said it was now possible in some cases to identify patients whose cancer was more likely to return after surgery by monitoring the levels of tumor DNA in their blood. Such patients may be more willing to try a new drug that might improve their chances of beating the disease for good.
He also pointed to the Food and Drug Administration's preliminary approval in 2013 of a Roche breast cancer drug for early-stage disease, based on a relatively short trial that showed it reduced the number of cancerous cells in the tissue surrounding the tumor before surgery. A yearslong follow-up trial confirmed that the drug, Perjeta, improved survival in the long term.
"What applies in breast ought to apply in the majority of tumor types," said Dr. Baselga. "Tumors don't care about location, humans do."
Write to Denise Roland at Denise.Roland@wsj.com
(END) Dow Jones Newswires
May 27, 2019 08:14 ET (12:14 GMT)
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