A cancer drug that is given to previously untreated patients works just as well when it's administered to untreated patients-in fact, even better.
The drug in study is called Imbruvica. A product of Abbvie and Johnson & Johnson, Imbruvica (ibrutinib) is recommended to chronic lymphocytic leukemia (CLL) patients who have received at least one type of treatment before the prescription, as well as patients with 17p deletion. It can also be used on patients with Waldenstrom's macroglubulinemia (WM) and mantel cell lymphoma (MCL) who have gone through one prior treatment.
The latest study is part of the RESONATE-2 trial and is already in phase 3. The researchers gave the same drug to at least 250 CLL patients who didn't have any treatment prior to the study. They were also older with ages beginning at 65 years old.
Based on their report, the drug performed better than chlorambucil, a chemotherapy drug, by decreasing the risk of death by as high as 85%. That's equivalent to only three deaths under Imbruvica versus more than 15 deaths in the chemotherapy protocol.
The pill also helped in slowing down the progression of the disease, which the researchers determined by getting the median progression-free survival (FPS) for each group. This refers to the length of time it took before the disease worsened for 50% of the CLL patients taking the drug and chemotherapy.
Those who took Imbruvica didn't experience any disease progression until more than 18 months after. But even then, only 10% experienced a worsening condition. Further, at least 86% of the patients taking the drug had reduced their cancer by half, higher than 35% of chemotherapy. They also did well in overall response rate.
Although two patients had to be discontinued in the program due to atrial fibrillation side effect, the abandonment rate for Imbruvica was still small at 9% than 23% of chemotherapy.
The drug makers are then looking into expanding the approval of the medication to cover untreated patients. Not only will this boost their sale, but it may also allow the patients to maximize the effect of the drug and minimize side effects of chemotherapy.
The companies are hoping to hear a decision by early next year. In the meantime, the study is now available in New England Journal of Medicine.
