CHICAGO— Pfizer on Friday it said medicine for an advanced form of lung cancer showed promising long-term results in a late-stage study, which may help it become the new standard treatment for the condition.
The company's drug made patients live longer without seeing their cancer progress, and most people experienced that benefit for more than five years. The drug, called Lorbrena, also reduced the risk of the cancer developing in patients' brains.
Lorbrena is already approved in the US for the treatment of adults with advanced non-small cell lung cancer a mutation in a gene called ALK. Only about 5% of all non-small cell lung cancer patients have the mutation, which causes cancer cells to grow and spread abnormally.
But that translates to 72,000 people diagnosed with that specific form of lung cancer each year worldwide, according to a Pfizer press release. That cancer is typically aggressive and often affects younger people, the company added.
More generally, non-small cell lung cancer is a common form of the disease.
Lorbrena is specifically approved as a first-line treatment for this form of lung cancer, meaning that patients taking it have not received any other therapy. But Pfizer's drug is not currently considered the standard of care — or the most appropriate and widely used — treatment for the condition.
The company thinks the new five-year data on the drug will change that.
“In cancer medicine in general, you always want to give the best drug first. That's why we believe these data… will lead to [Lorbrena] “It will become a standard” first-line treatment for this specific form of lung cancer, Chris Boshoff, Pfizer's chief of oncology, told CNBC in an interview.
The new five-year data comes from the same phase three trial that led to the American approval of Lorbrena. Pfizer will present the results on Friday at the American Society for Clinical Oncology annual meeting in Chicago, the largest cancer research conference in the world. The data was also published in the Journal of Clinical Oncology.
Nearly 300 people in the trial received Lorbrena or Pfizer's older lung cancer drug Xalkori. After five years, 50% of patients in the study were still receiving Lorbrena, compared with 5% of people receiving Xalkori.
In the trial, Lorbrena reduced the risk of cancer progression or death by 81% compared to Xalkori, after five years.
About 60% of patients treated with Lorbrena lived after the same period without their cancer progressing. That compares with 8% among those taking Xalkori.
Dr. David Spigel, chief scientific officer at the Sarah Cannon Research Institute, called these results “the best we've ever seen” during a briefing with reporters ahead of the ASCO conference.
“We haven't seen anything close to this yet. Other great drugs that are available … have not reported the kind of durable, progression-free survival events of this magnitude,” Spigel said, referring to the number of people who survived without seeing their own lives. progression of cancer.
He noted that there are 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, which are designed to block the mutations in the ALK gene that are linked to abnormal cancer cell growth. Lorbrena is considered a newer, third-generation ALK inhibitor, while the two competitors are second-generation.
But Spigel added that “it's hard to believe” that Lorbrena would perform worse against these drugs.
Pfizer's other drug Xalkori is also an ALK inhibitor, but is no longer used in the US
Lung cancers with the “ALK-positive” mutation are also particularly adept at spreading to the brain. About a quarter or more of patients may develop brain metastases within the first two years of diagnosis – when cancer cells spread from their original part of the body to the brain.
Lorbrena reduced the risk of the cancer developing in the brain by 94% compared to Pfizer's old drug. Only four of 114 patients taking Lorbrena developed brain metastases within about 16 months, compared with 39 of 109 taking Xalkori.
Lorbrena is effective in preventing and treating brain metastases because it can cross a membrane called the blood-Brian barrier and enter the brain, something not all drugs can do.
Spigel called that another “impressive finding,” as progression in the brain is “pretty terrible for patients and something we're desperately trying to prevent or treat.”
No new safety concerns have been reported for Lorbrena. The most common side effects included swelling, weight gain, cognition and mood changes, and high blood cholesterol.
But Spigel called the cognitive problems associated with Lorbrena “unusual” because it is not seen among its competitors.
In a note on Thursday ahead of the data release, Leerink Partners analyst Dr. Andrew Berens that he believes Lorbrena's side effects on the central nervous system are partly why it is often used as a second-line rather than first-line treatment for this advanced form of lung cancer. . Those changes in cognition and mood result “in a lower quality of life for the patient,” he said.
But Pfizer's Boshoff said that once doctors use Lorbrena for the first time, they feel comfortable dealing with the specific side effects associated with the drug.
He noted that educating doctors on how to manage side effects will be an important part of Lorbrena's “relaunch” after the release of the new data.
