AstraZeneca ($AZN) has high hopes for the in-development AZD9291, a treatment for lung cancer expected to bring in $3 billion a year at its peak, and the drugmaker is working with rival Roche ($RHHBY) to craft a blood test that can spot ideal patients for the therapy.
AZD9291 is designed to combat non-small cell lung cancer by inhibiting the mutated EGFR genes that spur the disease. However, unlike any other drug on the market, AstraZeneca's therapy goes a step further by blocking the T790 mutation, which almost always develops as tumor cells mount a resistance to initial treatment.
In an ongoing Phase I study, AstraZeneca's drug has shown early evidence of activity on patients with EGFR mutations who have failed on standard inhibitors and on those who have developed T790. But if the company wants to quickly execute a larger trial for AZD9291, it will need a new way of screening patients, and that's where Roche comes in.
As it stands, the only way to determine whether late-stage NSCLC patients have T790 mutations is to stage repeat biopsies, an inconvenient and time-consuming proposition. AstraZeneca is counting on Roche's diagnostics arm to craft a simple blood test that tracks circulating DNA in plasma samples to chart T790, potentially transforming how the company diagnoses and treats patients.
"This collaboration will enable molecular testing through plasma specimens and provide the information needed to inform treatment decisions without the complications of surgery, consequently increasing the level of care clinicians can give to the patient," Roche Molecular Diagnostics chief Paul Brown said in a statement.
Meanwhile, AstraZeneca is speeding through early development with AZD9291, one of the pillars of its long-term turnaround plan, as it races with Clovis Oncology ($CLVS). The drug's future is a major facet of AstraZeneca's promise to grow revenue by 75% over 10 years, expecting to reach $45 billion by 2023. And meeting that mark will require AZD9291 to beat out CO-1686, a similar EGFR/T790-targeting treatment from Clovis that is working through a Phase I/II study.
Now, AstraZeneca is in the midst of "the fastest-enrolling Phase I I've ever seen," Oncology iMed head Susan Galbraith told FierceBiotech at ASCO in May, hoping AZD9291's FDA breakthrough designation can accelerate its path to approval.
- read the statement