CHICAGO— Pfizer said Friday that its drug for an advanced form of lung cancer showed promising long-term results in a late-stage trial that could help establish it as a new standard treatment for the disease.
The company’s drug helped patients live longer without their cancer progressing, and most people experienced this benefit for over five years. The drug, called Lorbrena, also reduced the risk of cancer progressing in patients’ brains.
Lorbrena is already approved in the United States for the treatment of adults with advanced non-small cell lung cancer who have a mutation in a gene called ALK. Only about 5% of non-small cell lung cancer patients have the mutation, which causes cancer cells to grow and spread abnormally.
However, according to a statement from Pfizer, this means that 72,000 people worldwide are diagnosed with this particular form of lung cancer every year. The company added that cancer is typically 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 form of lung cancer, meaning patients taking it have not received any other therapy. However, Pfizer’s drug is not currently considered a standard treatment – or the most appropriate and widely used – treatment for this condition.
The company expects new five-year data on the drug to change that.
“In cancer medicine in general, you always want to offer the best medicine first. That’s why we believe this data…will lead to that.” [Lorbrena] Chris Boshoff, Pfizer’s chief oncology officer, told CNBC in an interview that this particular form of lung cancer is a “standard first-line treatment.”
The new five-year data comes from the same Phase III trial that led to Lorbrena’s U.S. approval. Pfizer will present the results on Friday at the annual meeting of the American Society of Clinical Oncology in Chicago, the largest cancer research conference in the world. The data was also published in the Journal of Clinical Oncology.
Nearly 300 participants in the study received either 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 study, 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 without their cancer progressing over the same period. This compares to 8% of those taking Xalkori.
Dr. David Spigel, chief scientific officer of 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 like it. Other great drugs available … have not reported durable, progression-free survival events of this magnitude,” Spigel said, referring to the number of people who remained alive without seeing cancer progress.
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 and 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 its two competitors are second-generation.
But Spigel added that it was “hard to believe” that Lorbrena would perform worse in a direct comparison with these drugs.
Xalkori, Pfizer’s other drug, is also an ALK inhibitor but is no longer used in the United States
Lung cancer with the “ALK-positive” mutation can also spread particularly well to the brain. About a quarter or more of patients may develop brain metastases — when cancer cells migrate from their original body part to the brain — within the first two years after diagnosis.
Lorbrena reduced the risk of cancer progressing to the brain by 94% compared to Pfizer’s old drug. Only four of the 114 patients who took Lorbrena developed brain metastases within about 16 months, compared with 39 of the 109 patients who took Xalkori.
Lorbrena is effective in preventing and treating brain metastases because it can cross a membrane called the blood-brain barrier and get into the brain, which not all drugs can do.
Spigel called this another “impressive finding” because the progression in the brain is “pretty terrible for patients and something we are desperately trying to prevent or treat.”
No new safety issues have been reported for Lorbrena. The most common side effects included swelling, weight gain, cognitive and mood changes, and high blood cholesterol levels.
But Spigel called the cognitive problems associated with Lorbrena “unusual” because it doesn’t occur in his competitors.
In a note on Thursday ahead of the data release, Leerink Partners analyst Dr. Andrew Berens said he believes Lorbrena’s central nervous system side effects are partly responsible for why it is often used as a second-line rather than first-line therapy for this advanced form of lung cancer. These changes in cognition and mood “resulted in a lower quality of life for the patient,” he said.
However, Pfizer’s Boshoff said that once doctors use Lorbrena for the first time, they can familiarize themselves with the drug’s specific side effects.
He noted that educating doctors about dealing with side effects will be an important part of Lorbrena’s “relaunch” following the release of the new data.
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2024-05-31 17:46:15
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