chicago – Pfizer said on friday drug advanced form of lung cancer It showed promising long-term results in a late-stage trial that could help establish it as a new standard treatment for the disease.
Company drugs Help patients live longer did not see their cancer progress, and most experienced this benefit over five years. The drug, Lorbrena, also reduces the risk of cancer progression in patients’ brains.
Lorbrena has been approved in the U.S. to treat adult patients with advanced non-small cell lung cancer Gene mutation It’s called ALK. only about 5% All patients with non-small cell lung cancer have this mutation, which causes the cancer cells to grow and spread abnormally.
But according to Pfizer’s press release, that means 72,000 people worldwide are diagnosed with this specific form of lung cancer every year. The company added that this cancer is often aggressive and often affects younger people.
More broadly, non-small cell lung cancer is a common form of the disease.
Lorbrena is specifically approved as a first-line treatment for this type of lung cancer, meaning patients taking the drug are not receiving any other treatments. But Pfizer’s drug is not currently considered the standard treatment for the disease, or the most appropriate and widely used treatment.
The company believes new five-year data on the drug will change that.
“Generally speaking, in cancer medicine, you always want to have the best drug available first. That’s why we believe these data … will lead to (Lorbrena) becoming the standard of care for this specific form of lung cancer” in first-line treatment , Chris Boshoff, chief oncology officer of Pfizer, said in an interview with CNBC.
The new five-year data comes from the same Phase 3 trial This resulted in Lobrenna being approved in the United States. Pfizer will be on Friday American Society of Clinical Oncology The annual meeting in Chicago is the world’s largest cancer research meeting. The data was also published in the Journal of Clinical Oncology.
Nearly 300 people in trial received Lorbrena or Pfizer’s older lung cancer drug solution. Five years later, 50% of patients in the trial were still receiving Lorbrena, compared with 5% of patients who received Xalkori.
In the trial, after five years, Lorbrena reduced the risk of cancer progression or death by 81% compared with Xalkori.
About 60% of patients treated with Lorbrena were alive after the same period without their cancer progressing. That compared with 8 percent of people taking Xalkori.
Briefing reporters before the ASCO meeting, Dr. David Spigel, chief scientific officer of the Sarah Cannon Research Institute, called the results “the best we have ever seen.” result”.
“We haven’t seen anything close to this,” Spiegel said, referring to the lack of reports of durable, progression-free survival events of this magnitude with other good drugs available… The proportion of people who are still alive despite taking their own lives.
He noted that there are currently no head-to-head trials comparing Pfizer’s Lorbrena to competing lung cancer drugs, including one called alectinib and another called brigatinib.
All three drugs, called ALK inhibitors, are designed to block mutations in the ALK gene that are associated with abnormal growth of cancer cells. Lorbrena is considered a newer, third-generation ALK inhibitor, while both competitors are second-generation.
But Spiegel added that it was “hard to believe” that Lobrenna would have fared worse in a head-to-head confrontation with the drugs.
Another Pfizer drug, Xalkori, is also an ALK inhibitor but is no longer used in the United States.
Lung cancers with “ALK-positive” mutations are also particularly likely to spread to the brain. About a quarter or more of patients may develop brain metastases – when cancer cells spread from their original site in the body to the brain – within the first two years after diagnosis.
Lorbrena reduced the risk of brain cancer progression by 94% compared with Pfizer’s older drug. Only 4 of 114 patients taking Lorbrena developed brain metastases within about 16 months, compared with 39 of 109 patients taking Xalkori.
Lorbrena is effective in preventing and treating brain metastases because it can cross a membrane called the blood-brain barrier and enter the brain, something that all drugs cannot.
Spiegel called this another “impressive finding” because the brain progression is “very scary for patients and something we desperately want to prevent or treat.”
There are no new safety issues reported in Lobrenna. The most common side effects include swelling, weight gain, cognitive and mood changes, and high blood cholesterol.
But Spigel called the perception issues associated with Lorbrena “unusual” because they haven’t been experienced by its competitors.
In a note ahead of Thursday’s data release, Leerink Partners analyst Dr. Andrew Berens said he believes Lorbrena’s central nervous system side effects are part of the reason it is often used as a second rather than first-line treatment for this advanced form of lung cancer. . These cognitive and emotional changes lead to a “decreased quality of life for patients,” he said.
But Pfizer’s Boshoff said that once doctors use Lorbrena for the first time, they will have no problem dealing with any specific side effects associated with the drug.
He noted that educating doctors on how to manage adverse effects will be an important part of Lobrenna’s “restart” after the new data are released.
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