Chicago – Pfizer The company said on Friday that its drug for advanced forms of lung cancer had shown promising long-term results in a late-stage clinical trial, which could help establish it as a new standard treatment for lung cancer.
The company’s drugs have helped patients live longer without their cancer developing, with most people experiencing those benefits 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. to treat adults with advanced non-small cell lung cancer who have mutations in a gene called ALK. Only about 5% of all non-small cell lung cancer patients have mutations that cause cancer cells to grow and spread abnormally.
However, according to Pfizer, this represents 72,000 people worldwide who are diagnosed with some form of lung cancer each year. The cancer is typically aggressive and often affects young people, the company added.
More broadly, non-small cell lung cancer is a common form of this disease.
Lorbrena is specifically approved as a first-line treatment for this form of lung cancer. That is, patients taking Lorbrena did not receive any other treatment. However, Pfizer’s drug is not currently considered the standard or most appropriate or widely used treatment for the disease.
The company believes the new five-year data on the drug will change that.
“In cancer medicine in general, you always want to deliver the best drug first, so we believe that these data … will make (Lorbrena) the standard” first-line treatment in this particular form of lung cancer. Chris Boshoff, Pfizer’s chief oncology officer, said in an interview with CNBC:
The new five-year data comes from the same Phase 3 trial that led to Lorbrena’s U.S. approval. Pfizer plans to present the results Friday at the annual meeting of the American Society of Clinical Oncology, the world’s largest cancer research conference, in Chicago. This data was also published in the Journal of Clinical Oncology.
About 300 people who participated in the clinical trial were administered Lorbrena or Pfizer’s older lung cancer treatment Xalkori. Five years later, 50% of patients in the trial were still receiving Lorbrena, compared with 5% receiving Xalkori.
In clinical trials, Lorbrena reduced the risk of cancer progression or death by 81% compared to Xalkori after five years.
Approximately 60% of patients treated with Lorbrena remained alive after the same period with no progression of their cancer. This compares to 8% of people who took Xalkori.
Dr. David Spigel, chief scientific officer of the Sarah Cannon Research Institute, called these results “the best we’ve ever seen” in a briefing with reporters ahead of the ASCO meeting.
“We’ve never seen anything like this. No other great drug available has reported sustained, progression-free survival on this scale,” Spigel said. Cancer progression.
He noted that no clinical trials have directly compared Pfizer’s Lorbrena with competing lung cancer drugs, including Alectinib and Brigatinib.
All three are called ALK inhibitors and are designed to block mutations in the ALK gene that are associated with abnormal cancer cell growth. Lorbrena is considered a new third-generation ALK inhibitor, while both competitors are second-generation.
But Spigel added that it’s “hard to believe” Lorbrena would perform worse head-to-head against these drugs.
Pfizer’s other drug, Xalkori, is also an ALK inhibitor, but is no longer used in the United States.
Lung cancers with “ALK-positive” mutations are particularly adept at spreading to the brain. Approximately a quarter or more of patients may develop brain metastases (when cancer cells spread from their original part of the body to the brain) within the first two years after diagnosis.
Lovrena reduced the risk of brain cancer progression by 94% compared to Pfizer’s existing drug. Among 114 patients taking Lovrena, only 4 developed brain metastases within about 16 months, compared to 39 out of 109 patients taking Xalkori.
Lovrena is effective in preventing and treating brain metastases because it can enter the brain through the blood-brain barrier, which all drugs cannot.
Spigel said another “impressive discovery” after the brain’s progression was “something that’s so devastating 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, cognitive and mood changes, and increased blood cholesterol.
But Spigel said the cognitive challenges associated with Lorbrena are “unique” because they are not seen in its competitors.
In a note published Thursday ahead of the data release, Leerink Partners analyst Dr. Andrew Berens said he believes Lorbrena’s central nervous system side effects are partly why it is often used as a second-line rather than first-line treatment for advanced lung cancer. . . These changes in cognition and mood “reduce patients’ quality of life,” he said.
But Pfizer’s Boshoff said doctors who use Lorbrena for the first time feel comfortable managing certain side effects associated with the drug.
He noted that training doctors on how to manage side effects will be an important part of Lorbrena’s “relaunch” following the release of new data.
