Lorbrena has already received approval in the U.S. for the treatment of advanced non-small cell lung cancer in adults who possess a mutation in the ALK gene. This specific mutation, found in only about 5% of non-small cell lung cancer patients, leads to abnormal growth and spread of cancer cells.
According to a release from Pfizer, approximately 72,000 individuals worldwide are diagnosed each year with this particular type of lung cancer. The company states that this form of cancer is typically aggressive and tends to impact younger individuals.
Non-small-cell lung cancer is a prevalent type of cancer that affects the lungs.
Lorbrena has been specifically approved as the initial treatment for this type of lung cancer. This means that patients who opt for Lorbrena have not undergone any other therapy. However, it should be noted that Pfizer’s drug is not currently regarded as the standard or the most commonly used treatment for this condition.
According to the company, they believe that the newly obtained data spanning over five years will have a transformative impact on the perception of the drug.
“In the field of cancer medicine, the primary goal is to administer the most effective medication as the initial treatment option. This is why we are confident that the findings from this data will establish Lorbrena as the standard first-line therapy for this particular type of lung cancer,” stated Chris Boshoff, Pfizer’s chief oncology officer, during an interview with CNBC.
Pfizer will be presenting the results of the new five-year data from the phase three trial that led to the U.S. approval of Lorbrena. This presentation will take place on Friday at the American Society of Clinical Oncology annual meeting in Chicago, which is considered the largest cancer research conference globally. In addition to the presentation, the findings have also been published in the Journal of Clinical Oncology.
In the trial, around 300 participants were administered either Lorbrena or Pfizer’s previous lung cancer medication, Xalkori. After five years, it was observed that 50% of the patients who received Lorbrena were still continuing with the treatment, while only 5% of those who received Xalkori were still on the drug.
During the trial, Lorbrena demonstrated a significant reduction in the risk of cancer progression or death after five years, with an impressive 81% decrease compared to Xalkori.
Around 60% of patients who underwent treatment with Lorbrena managed to maintain a cancer-free progression after the same duration. In contrast, only 8% of those who received Xalkori experienced a similar outcome.
Dr. David Spigel, the chief scientific officer at the Sarah Cannon Research Institute, expressed his excitement about the results, stating that they are “the best we’ve ever seen.” He shared this during a briefing with reporters before the ASCO conference.
“We haven’t witnessed anything quite like this before. Other remarkable medications that are on the market have not documented such significant and long-lasting instances of patients’ survival without the progression of their cancer,” Spigel commented, emphasizing the remarkable rate of individuals who remained alive while their cancer did not advance.
There have been no head-to-head trials comparing Pfizer’s Lorbrena with other lung cancer drugs like alectinib and brigatinib, as noted by the expert.
There are three types of ALK inhibitors: Lorbrena, a third-generation inhibitor, and two second-generation inhibitors. These inhibitors are specifically designed to block the mutations in the ALK gene that are responsible for abnormal cancer cell growth.
Spigel expressed skepticism about the notion that Lorbrena would fare worse when directly compared to those drugs.
Pfizer’s other drug, Xalkori, which is also an ALK-inhibitor, is no longer prescribed in the U.S.
Lung cancers that have the “ALK-positive” mutation have a particular ability to spread to the brain. Within the first two years of diagnosis, approximately a quarter or more of patients may develop brain metastases, where cancer cells spread from the original site of the tumor to the brain.
Lorbrena significantly reduced the risk of cancer progression in the brain by 94% in comparison to Pfizer’s previous drug. Out of the 114 patients who were treated with Lorbrena, only four developed brain metastases within approximately 16 months. In contrast, 39 out of the 109 patients who received Xalkori experienced the same outcome.
Lorbrena effectively prevents and treats brain metastasis by crossing the blood-brain barrier and entering the brain, a capability not possessed by all drugs.
According to Spigel, this is another “impressive finding” because the progression in the brain is a terrible experience for patients, and something that doctors are always striving to prevent or treat.
Users of Lorbrena did not report any new safety concerns. The most frequently experienced side effects included swelling, weight gain, changes in cognition and mood, and elevated levels of cholesterol in the blood, among others.
Spigel noted that the cognitive issues linked to Lorbrena are considered “unusual” because they are not typically observed with other competing medications.
According to Dr. Andrew Berens, an analyst at Leerink Partners, Lorbrena is frequently used as a second-line treatment for advanced lung cancer due to its central nervous system side effects. These side effects can affect a patient’s cognition and mood, leading to a decrease in their quality of life.
According to Pfizer’s Boshoff, physicians who have experience using Lorbrena become adept at managing any potential side effects that may be associated with the drug.
According to him, a crucial aspect of Lorbrena’s “relaunch” after the new data is released will be educating physicians on how to effectively manage adverse effects.