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FDA Calls AstraZeneca PLC (AZN) and MedImmune (AZN)’s Imfinzi a Breakthrough

7/31/2017 6:41:46 AM

FDA Calls AstraZeneca and MedImmune’s Imfinzi a Breakthrough July 31, 2017
By Alex Keown, Breaking News Staff

WASHINGTON – After a tough week, London-based AstraZeneca (AZN) received some good news. This morning, the company announced the U.S. Food and Drug Administration awarded Imfinzi (duravulumab) the Breakthrough Therapy Designation for treatment of some lung cancer patients.

Imfinzi, a PD-L1 inhibitor, received the designation for patients with locally-advanced, unresectable non-small cell lung cancer (NSCLC) whose disease has not progressed following platinum-based chemoradiation therapy. The FDA’s Breakthrough Therapy Designation is designed to expedite the development and regulatory review of new medicines that are intended to treat a serious condition and that have shown encouraging early clinical results.

The FDA granted the designation following the announcement of interim results from its Phase III Pacific Trial in May. Interim results from the trial showed that Imfinzi had already met its primary endpoint, which was statistically significant and clinically meaningful progression-free survival (PFS). It also showed a favorable benefit/risk profile. AstraZeneca and MedImmune (AZN), its biologics research and development arm, are still awaiting results on overall survival.

Sean Bohen, AstraZeneca’s chief medical officer, touted the FDA’s decision. In a statement this morning, he said Imfinzi, if approved for this lung cancer designation, will provide a needed treatment option. The current standard of care is chemotherapy and radiation followed by active surveillance to monitor for progression. The prognosis remains poor and long-term survival rates are low.

“For patients who have not progressed following chemoradiation therapy the only current option is active monitoring. Unfortunately, for the majority of patients, their cancer will progress to metastatic disease, typically within 12 months. Imfinzi is the first immuno-oncology medicine to show a clinically-significant benefit in this earlier, non-metastatic setting, so following the Breakthrough Designation we hope to bring it to patients as soon as possible,” Bohen said in a statement.
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Imfinzi has previously received accelerated approval from the FDA for the treatment of advanced bladder cancer.

The FDA’s decision somewhat softens the blow that AstraZeneca took last week after the company announced that Imfinzi in combination with tremelimumab, a CTLA-4 inhibitor, failed to meet endpoints in the highly critical Phase III Mystic trial. AstraZeneca said the Mystic trial did not meet its primary endpoint in progression free survival in patients whose tumors express PD-L1 on 25 percent or more of their cancer cells. Adding insult to injury, AstraZeneca said that although it was not formally tested, Imfinzi as a monotherapy would also have failed to meet a pre-specified threshold of progression free survival over standard of care in the same disease setting.

Not only did AstraZeneca deal with the fallout from the Mystic trial, the company was also plagued by rumors its CEO Pascal Soriot was abandoning ship for Israel-based Teva Pharmaceuticals (TEVA). The company ultimately denied the rumors, but only after taking several days to do so, costing it about $4 billion in market value as investors dumped shares of company stock.

Investors are reacting positively to the FDA’s designation for Imfinzi. This morning, shares are up slightly, trading at $30.68 as of 10:12 a.m. Last week shares fell to a six-month low of $28.53 following the announcement of the Mystic failure.

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