AstraZeneca PLC Loses $10 Billion in Value as Long-Awaited MYSTIC Trial Disappoints
July 27, 2017
By Alex Keown, BioSpace.com Breaking News Staff
LONDON – British Pharma giant AstraZeneca suffered a major setback in its long-awaited Phase III Mystic lung cancer trial that cost the company $10 billion in market value overnight. The combination treatment of PD-1 inhibitor Imfinzi (durvalumab) and tremelimumab, a CTLA-4 inhibitor, failed to meet endpoints.
Shares of AstraZeneca were down more than 15 percent in premarket trading, falling to $28.71. The immuno-oncology trial failure has possibly crushed AstraZeneca Chief Executive Officer Pascal Soriot’s drive to generate $45 billion in annual revenue by 2023.
In its announcement this morning, 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.
While the results are not what the beleaguered company has been hoping for, AstraZeneca said the trial will continue in order to assess two additional primary endpoints of overall survival in both the combination treatment as well as a monotherapy treatment.
If the Mystic trial had hit, Bloomberg analysts speculated Imfinzi, which is already approved for the treatment of bladder cancer in the United States, could have become a $7 billion per year drug for the company. That would have made it AstraZeneca’s best-selling medicine, Bloomberg noted.
The failure of the Mystic trial could spell trouble for Soriot, who only a few weeks ago was rumored to be leaving AstraZeneca to take over the helm of generics drug giant Teva Pharmaceuticals . Although Soriot and AstraZeneca ultimately dispelled that rumor following several days of silence that cost the company $4 billion in market value, some analysts are suggesting Soriot could be urged to leave the company now. Mick Cooper, an analyst with Trinity Delta, a U.K. firm specializing in the life sciences, told the Telegraph that there will be more pressure on Soriot following the failure of the Mystic trial.
“He promised to get to $45bn (billion) sales by 2023 and with the readout on Imfinzi as it is it is hard to believe he will get anywhere near that,” Cooper told the Telegraph.
In a call with reporters, Soriot called for patience from investors, pointing to the additional overall survival endpoints the Mystic trial could still meet, the Telegraph said. Soriot also said that Imfinzi is being studied in multiple monotherapy and combination trials, including small-cell lung cancer and head and neck squamous cell carcinoma. Recently, the U.S. Food and Drug Administration gave AstraZeneca an accelerated approval for Imfinzi in treating patients with locally advanced or metastatic urothelial carcinoma.
AstraZeneca sought to curb some investor concerns this morning by also announcing that its EGFR tyrosine kinase inhibitor Tagrisso met Phase III endpoints in previously-untreated patients with locally-advanced or metastatic epidermal growth factor receptor mutation-positive (EGFRm) non-small cell lung cancer (NSCLC). The company said Phase III results showed Tagrisso showed a statistically-significant and clinically-meaningful progression-free survival (PFS) benefit compared to current 1st-line standard-of-care treatments. While AstraZeneca’s stock plummets, rival Merck, which has its own PD-1 inhibitor Keytruda, is on the rise this morning. Shares of Merck were up more than 4 percent in premarket trading, hitting $64.50.
AstraZeneca and Merck also announced today that the two companies have struck a deal to collaborate on combining AstraZeneca’s PARP inhibitor Lynparza with Merck’s PD-1 inhibitor Keytruda to test against multiple cancer types.