AstraZeneca pivots to early-stage cancer in search of a niche

AstraZeneca's José Baselga, M.D., Ph.D. (Memorial Sloan Kettering Cancer Center)

AstraZeneca is set to prioritize the treatment of early-stage cancers under the leadership of oncology research chief José Baselga, M.D., Ph.D. Talking to The Wall Street Journal, Baselga sketched out why he thinks splitting off from the congested pursuit of late-stage cancers will benefit AstraZeneca and patients.

Under Baselga, AstraZeneca’s oncology group will initially test drugs in advanced patients to gather safety data. Once drugs clear that early test, Baselga plans to redirect development toward patients with earlier-stage cancers. Baselga, a breast cancer doctor, thinks the focus will help AstraZeneca maximize the impact of its R&D spending.  

“We need to spend our resources on those places where we can cure more people and that’s in early disease,” Baselga said. “It’s a deep philosophical belief that we have.”

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That philosophical belief may butt up against other factors in the years to come. Companies target later-stage cancers for a range of solid reasons, including the willingness of patients to try unproven therapies and the scope for trials to quickly show a drug improves survival rates.

Some early-stage patients have existing, potentially curative options such as surgery, chemotherapy and radiotherapy. To compete, AstraZeneca may need to clear high bars and track trial subjects for longer than is typical to demonstrate survival benefits.

The upshot is, some observers think AstraZeneca faces an uphill struggle to make the strategy work. 

“It’s not impossible, but it would involve a major change in paradigm outside of breast cancer,” Citi analyst Andrew Baum said.

Most breast cancers are detected in their early stages, incentivizing companies to develop drugs for these patients. But the industry has made limited inroads into the development of drugs to treat other cancers early.

AstraZeneca’s involvement in one effort to target earlier-stage cancers predates the appointment of Baselga. The Big Pharma carved out a niche for Imfinzi in stage 3 non-small cell lung cancer (NSCLC) and began a phase 3 trial of the PD-L1 inhibitor in stage 2 NSCLC patients around the time of Baselga’s appointment.

Working with collaborators over the past 15 years, AstraZeneca has tested other drugs including Iressa and Tagrisso in cancers from stage 1 onward, in some cases to try to shrink tumors before they are removed surgically. 

The broader landscape of clinical trials targeting earlier-stage cancers reflects the studies involving AstraZeneca. Most studies involve academic medical centers, sometimes in collaboration with major biopharma companies. Much of the industry-led activity, such as Merck’s Keytruda trial in stage 1 and 2a NSCLC, overlaps with AstraZeneca’s existing efforts to tackle cancers earlier in their development.

Few biotechs are running trials in patients with earlier-stage cancers, giving AstraZeneca limited options if it wants to buy in clinical-phase assets shown to fit with Baselga’s strategy. The exceptions include Klus Pharma, which is accepting patients with certain early-stage tumors such as stage 1 rectal cancer in a phase 1/2 trial of anti-HER2 antibody-drug conjugate A166. Dendreon, meanwhile, is working to establish Provenge as an option for patients with low-risk prostate cancer. 

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