Takeda Pharmaceutical Co. Ltd.'s phase 2 trial of Alunbrig showed that the drug reduced the tumor size in patients with a common form of lung cancer who have progressed on Pfizer Inc.'s Xalkori.
The patients with anaplastic lymphoma kinase-positive metastatic non-small cell lung cancer received either 90 milligrams of the drug once daily or 180 mg once daily after a seven-day lead-in of 90 mg once daily, with a median follow-up period of 16.8 months and 18.6 months, respectively.
Results showed that 46% of patients on the 90 mg dose saw their tumor shrink, while 55% of patients in the 180 mg group saw a reduction in tumor size. The confirmed objective response rate by the independent review committee was 51% in the 90 mg group and 55% in the 180 mg group.
The patients in the 90 mg group lived for a median of 9.2 months without the disease worsening and the 180 mg group survived for a median of 15.6 months while keeping the disease at bay. The independent review committee noted the same median progression-free survival in the 90 mg group, but assessed that it was 16.7 months in the 180 mg group.
Median overall survival was not reached in the 90 mg group but it was 27.6 months in the 180 mg group.
In 180 mg group, 67% of patients whose cancer had spread to the brain saw their tumor shrink and 50% of such patients in the 90 mg group saw a shrinkage in their tumor size.
Takeda said the efficacy and safety data from the trial continues to support future trials with the 180 mg dosing regimen.
In April, the U.S.Food and Drug Administration granted accelerated approval to Alunbrig.