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Pfizer’s breast cancer drug Ibrance fails late-stage study

(Reuters) – Pfizer Inc said on Friday its cancer drug Ibrance did not meet the main goal in a late-stage trial in patients with a type of breast cancer, the latest setback in the company’s attempt to expand the use of the drug to treat early stages of the disease.

The latest development comes after an independent data monitoring committee said in May a similar trial comparing Ibrance plus an endocrine therapy to a standalone endocrine therapy to treat early-stage breast cancer was unlikely to meet the main goal.

Ibrance is already approved in the United States to treat certain adult patients with advanced breast cancer which has spread to other parts of the body. The drug has not yet been approved for treating early stages of the disease.

This puts the drug at a relative disadvantage to rival Eli Lilly and Co, which in June posted data showing that its drug Verzenio, met the trial goal of reducing the risk of early-stage breast cancer from recurring.

“Today’s data leaves Lilly’s Verzenio as the clear winner in the adjuvant space for now, giving Verzenio a blockbuster opportunity in a potential early breast cancer indication,” Cantor Fitzgerald analyst Louise Chen said.

In the late-stage trial, Ibrance failed to meet the main goal of increasing the amount of time patients survived without their cancer returning.

Lilly’s shares were up 1% at $155.10 in pre-market trading, while Pfizer’s stock was flat at $36.90.

(Reporting by Manojna Maddipatla in Bengaluru; Editing by Shailesh Kuber and Shounak Dasgupta)

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Will Pfizer’s Vaccine Be Ready in October? Here’s Why That’s Unlikely.

In media appearances and talks with investors, Pfizer’s chief executive nearly always mentions a word that is so politically perilous, most of his competitors shy away from it: October.

“Right now, our model — our best case — predicts that we will have an answer by the end of October,” the chief executive, Dr. Albert Bourla, told the “Today” show earlier this month. In other interviews, he has said he expected a “conclusive readout” by then, with an application for emergency authorization that could be filed “immediately.”

Dr. Bourla’s statements have put his company squarely in the sights of President Trump, who has made no secret of his desire for positive vaccine news to boost his chances on Election Day, Nov. 3. “We’re going to have a vaccine very soon. Maybe even before a very special date,” Mr. Trump said recently.

And yet by all other accounts, the idea that it will be ready in October is far-fetched. Even if the vaccine shows promising signs in clinical trials — still a big if — the company will not have collected enough data by then to say with any statistical confidence that it is safe and effective.

By repeating a date that flies in the face of most scientific predictions, Dr. Bourla is making a high-stakes gamble. If Pfizer puts out a vaccine before it has been thoroughly tested — something the company has pledged it will not do — it could pose a major threat to public safety. The perception matters, too: If Americans see the vaccine as having been rushed in order to placate Mr. Trump, many may refuse to get the shot.

But there is a significant upside, to the tune of billions of dollars, in being first to the U.S. market with a vaccine. And staying in the president’s good graces — particularly when he keeps talking about ways to lower drug prices — might not be a bad thing for a company that brought in nearly $40 billion in 2019 from sales of high-priced, brand-name drugs.

“There’s a huge financial advantage to being first out of the gate,” said Dr. Megan Ranney, an associate professor of emergency medicine and public health at Brown University. She was one of 60 public health officials and others in the medical community who signed a letter to Pfizer urging it not to rush its vaccine.

And given the White House’s persistent efforts to interfere in the decisions of federal health agencies, some scientists fear a vaccine approval could come under similar pressure.

“What I worry about is that the politics or the financial gain may drive earlier release than is scientifically appropriate,” Dr. Ranney said.

Pfizer will not be anywhere near completion of its clinical trial by the end of October, according to a company spokeswoman. When Dr. Bourla referred to a “conclusive readout” next month, she said, he meant that it’s possible the outside board of experts monitoring the trial would have by that date found promising signs that