CHICAGO — Pfizer on Friday he said yes bow for advanced form lung cancer showed promising long-term results in a late-stage trial, which could support establish it as a recent standard treatment for the disease.
Company medicine helped patients live longer without seeing the cancer progress, and most people experienced this benefit for more than five years. The drug, called Lorbrena, also reduces the risk of cancer developing in patients’ brains.
Lorbrena is already approved in the U.S. for the treatment of adults with advanced non-small cell lung cancer mutation in the gene called ALK. Just about 5% all patients with non-small cell lung cancer have a mutation that causes cancer cells to grow and spread abnormally.
According to Pfizer’s announcement, this means that 72,000 people around the world are diagnosed with this particular form of lung cancer each year. The company added that cancer tends to be aggressive and often affects younger people.
More broadly, non-small cell lung cancer is a common form of the disease.
Lorbrena was specifically approved as a first-line treatment for this form of lung cancer, which means that patients taking it did not receive any other treatment. However, Pfizer’s drug is not currently considered the standard – or the most appropriate and widely used – treatment for the disease.
The company believes the recent five-year data for the drug will change that.
“Generally speaking, in oncology medicine, you always give the best drug first. So we believe that this data will… lead to [Lorbrena] “will become the standard” first-line treatment for this specific form of lung cancer, Chris Boshoff, Pfizer’s chief oncology officer, told CNBC.
The recent five-year data comes from the same source phase three trial which led to Lorbrena’s approval in the US. Pfizer’s results will be presented on Friday at American Society of Clinical Oncology annual meeting in Chicago, the world’s largest cancer research conference. The data were also published in the Journal of Clinical Oncology.
Nearly 300 people in the study received Lorbrena or Pfizer’s older lung cancer drug Solution. After five years, 50% of patients in the study were still receiving Lorbrena compared with 5% of those receiving Xalkori.
In the study, Lorbrena reduced the risk of cancer progression or death by 81% after five years compared to Xalkori.
About 60% of patients treated with Lorbrena survived and their cancer did not progress after the same period. For comparison, among people who took Xalkori, this percentage was 8%.
Dr. David Spigel, chief scientific officer at the Sarah Cannon Research Institute, called the results “the best we’ve ever seen” during a briefing with reporters ahead of the ASCO conference.
“We haven’t observed anything like this. The other great drugs that are available … have not reported such tough progression-free survival on this scale,” Spigel said, referring to the percentage of people who survive without seeing their cancer progress.
He noted that there have been no head-to-head studies comparing Pfizer’s Lorbrena with competing lung cancer drugs, including one called alectinib and another called brigatinib.
All three are called ALK inhibitors and are designed to block mutations in the ALK gene associated with abnormal growth of cancer cells. Lorbrena is considered a newer, third-generation ALK inhibitor, while both competitors are second-generation ALK inhibitors.
However, Spigel added that it is “challenging to believe” that Lorbrena would fare worse compared to these drugs.
Another Pfizer drug, Xalkori, is also an ALK inhibitor but is no longer used in the US
“ALK-positive” mutation-positive lung cancers also spread particularly well to the brain. About a quarter or more of patients may develop brain metastases – when cancer cells spread from the original part of the body to the brain – within the first two years of diagnosis.
Lorbrena reduced the risk of developing brain cancer by 94% compared to the ancient Pfizer drug. Only four of 114 patients taking Lorbrena developed brain metastases within around 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, which all drugs cannot.
Spigel called it another “impressive discovery” because the brain progression is “pretty terrible for patients and something we’re desperately trying to prevent or treat.”
No recent safety concerns have been reported with Lorbrena. The most common side effects included swelling, weight gain, changes in cognitive function and mood, and high blood cholesterol levels.
However, Spigel called the cognitive problems associated with Lorbrena “unusual” because they are not seen in competitors.
In a pre-data note on Thursday, Leerink Partners analyst Dr. Andrew Berens said he believes Lorbrena’s central nervous system side effects are partly due to the fact that it is often used as a second-line, rather than first-line, treatment for this advanced form of disease. lung cancer. . These changes in cognitive functioning and mood result in “poorer quality of life for patients,” he said.
However, Pfizer’s Boshoff said that once doctors apply Lorbrena for the first time, they will have the freedom to manage any specific side effects associated with the drug.
He noted that educating doctors on how to manage side effects will be an vital part of the “relaunch” of Lorbrena once recent data is published.
