Takeda Pharmaceutical’s Alunbrig (brigatinib) hit its Phase III primary endpoints of statistically significant improvement in progression-free survival compared to crizotinib (Pfizer’s Xalkori) in a subset of lung cancer patients following the first pre-specified interim analysis.
Takeda Pharmaceutical‘s Alunbrig (brigatinib) hit its Phase III primary endpoints of statistically significant improvement in progression-free survival compared to crizotinib (Pfizer’s Xalkori) in a subset of lung cancer patients following the first pre-specified interim analysis.
The late-stage trial assessed Alunbrig’s efficacy in comparison to Xalkori as a treatment for adults with anaplastic lymphoma kinase-positive (ALK+) locally advanced or metastatic non-small cell lung cancer (NSCLC) who had not received a prior ALK inhibitor. This was good news for Takeda, as the company has been aiming for Alunbrig’s use as a front-line treatment in lung cancer. The news also reaffirmed Takeda’s 2017 acquisition of ARIAD Pharmaceuticals for $5.2 billion. Ariad developed Alunbrig.
Jesús Gomez-Navarro, Takeda’s head of oncology clinical research, said the positive Phase III news represents a major milestone in the company’s Alunbrig program. Gomez-Navarro said the company’s Alunbrig goal has been to improve the lives of patients with ALK+ NSCLC by furthering the available therapeutic options.
“We are encouraged by the data, which demonstrated a statistically significant improvement in progression-free survival versus crizotinib in patients with ALK+ advanced NSCLC, and look forward to beginning discussions with regulatory authorities as we seek to expand Alunbrig’s indication into the frontline setting,” Gomez-Navarro said in a statement.
Takeda did not provide many details of how well Alunbrig stacked up against Xalkori, only to note that the Phase III comparison trial hit its primary endpoint following an assessment by the Independent Review Committee. The results from this interim analysis will be submitted for presentation at an upcoming medical meeting, Takeda said.
The Phase III ALTA-1L trial included 275 patients with ALK+ locally advanced or metastatic NSCLC who have not received prior treatment with an ALK inhibitor. Trial patients received either a once-daily dose of Alunbrig at 180 mg with a seven-day lead-in or Pfizer’s Xalkori at 90 mg. Takeda said it plans approximately 198 progression-free survival events at the final analysis of the primary endpoint “in order to demonstrate a minimum of six months PFS improvement over crizotinib.” The trial is designed with two pre-specified interim analyses for the primary endpoint – one at 50 percent of planned PFS events and one at 75 percent of planned PFS events, Takeda said.
For NSCLC patients who are ALK-positive, there are not many therapeutic options available. There is a high unmet need for this population, Takeda said. The rare form of lung cancer affects approximately 40,000 people across the globe on an annual basis. The disease typically affects younger patients in comparison to other forms of lung cancers, with the median age of diagnosis 52 years old, Takeda said. The company also noted that ALK+ NSCLC is more often found in light or non-smokers, as opposed to heavy smokers.
