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(Bloomberg) -- Test results for AstraZeneca Plc’s next-generation cancer therapy -- among the most anticipated in the pharmaceutical industry this year -- stand to rijig the order of dominance in a field led by Merck & Co.
The U.K. drugmaker aims to show that Imfinzi, poised to become Astra’s biggest medicine by sales, was better than chemotherapy in checking the growth of lung tumors in a study dubbed Mystic. The results, due mid-year, could give it an edge in immuno-therapies -- a new class of drugs that activate the body’s defense system to attack tumors -- over rivals including Merck, Roche Holding AG and Bristol-Myers Squibb Co.
Failure, on the other hand, is likely to erase most of the $15 billion in market value that Astra has gained this year as its stock climbed to a record in anticipation of the trial results. It would also call into question Chief Executive Officer Pascal Soriot’s decision to keep the company independent when he rebuffed Pfizer Inc.’s $117 billion-takeover bid in 2014, and his ability to deliver on ambitious long-term sales targets.
Deadly lung tumors have become a crucial battleground for drugmakers in the closely contested race to develop life-saving cancer therapies. Last year, after Bristol-Myers unexpectedly lost its lead following the failure of a key study, Astra amended the design of its three-year study to improve Imfinzi’s odds.
Mystic’s success would put the Cambridge, U.K.-based drugmaker “in a very strong place,” said David Gilligan, an oncologist who specializes in lung tumors and is a trustee of the Roy Castle Lung Cancer Foundation in Liverpool.
Shares of Astra have soared more than 20 percent this year, outpacing gains made by local rival GlaxoSmithKline Plc or the U.K.’s benchmark equity index. In recent weeks, it has even on occasion soared past the 55 pounds-a-share that Pfizer offered three years ago, though it closed on Tuesday at 53.47 pounds in London trading. If the study fails to demonstrate the drug’s superiority, the stock could drop by more than 10 percent, analysts say.
Analysts currently expect Imfinzi to generate about $6.72 billion in annual revenue by 2022 when used by itself or in combination with other medicines, according to data compiled by Bloomberg.
“Imfinzi is the cornerstone for all our combinations,” David Berman, head of oncology at Astra’s MedImmune division, told reporters in London last week. The company doesn’t know the outcome of the study or the specifics of when it may be released, a spokeswoman said.
Studies such as Mystic can be a make-or-break moment for drugmakers. For Bristol-Myers, the failure of its Opdivo immuno-therapy in a clinical trial for lung cancer led to more than a fifth of its market value being wiped out since the end of July. Now Merck, whose Keytruda drug is already approved to be the first line of treatment for people with a common and aggressive form of the disease, is considered the favorite.
Doctors are cautiously optimistic about the immuno-therapies.
The class of drugs “present quite an opportunity for change,” said Gilligan. “It is a significant addition to the lung cancer armory, but it’s not a cure.”
Astra’s drug is a PD-L1 inhibitor, designed to counter tumors’ ability to evade the human body’s natural defense system by blocking a cancer-cloaking protein that’s heavily manufactured by some malignant growths.
In Mystic, it’s being tested as the first line of treatment for patients with non-small cell lung cancer -- a common form of the disease -- where the tumors have spread. The goal is to show that the drug, when combined with another Astra immuno-therapy called tremelimumab, is more effective than chemotherapy for patients with a high level of the PD-L1 biomarker, and in a broader group of people with tumors.
Both physicians and investors will also be looking closely at the incidence and severity of adverse reactions to gauge Imfinzi’s potential.
By early 2018, Astra hopes to have further evidence that the medicine, used by itself or in combination, also helps increase life expectancy. Identifying that measure, known as overall survival, as one of the key goals for the trial was among changes made by Astra in recent months.
“We recognized -- along with the field -- that overall survival is an even more robust endpoint,” according to Robert Iannone, AstraZeneca’s head of immuno-oncology treatments.
Making Imfinzi and other oncology treatments a success is a cornerstone of Soriot’s pledge to boost Astra’s sales to at least $40 billion by 2023, from about $23 billion last year. Failing on that front could make Astra vulnerable, once again, to speculation of a takeover.
--With assistance from Chiara Remondini and Michelle Fay Cortez
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