Positive breakthrough for new lung cancer drug developed at The Royal Marsden
Professor Sanjay Popat, consultant medical oncologist at The Royal Marsden NHS Foundation Trust is lead reseracher on new drug developed for lung cancer treatment
02 March 2020
Takeda Pharmaceutical Company Limited today announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending the approval of ALUNBRIG (brigatinib) as a monotherapy for the treatment of adult patients with anaplastic lymphoma kinase-positive (ALK+) advanced non-small cell lung cancer (NSCLC) previously not treated with an ALK inhibitor. ALUNBRIG is a next-generation tyrosine kinase inhibitor (TKI) that was designed to target and inhibit ALK genetic alterations.
“Because of the complex nature of ALK+ NSCLC and the way in which the disease often spreads to the brain, it is essential for physicians to have treatment options that demonstrate both overall and intracranial effectiveness,” said Professor Sanjay Popat, Consultant Medical Oncologist, Royal Marsden NHS Foundation Trust. “In the ALTA-1L trial, brigatinib demonstrated significant responses in the brain and consistent overall efficacy compared to crizotinib. If approved by the EMA, brigatinib has the potential to become an important option for the first-line treatment of ALK+ advanced NSCLC patients in Europe.”
This opinion is based on data from the Phase 3 ALTA-1L trial, which is evaluating the safety and efficacy of ALUNBRIG compared to crizotinib in patients with ALK+ locally advanced or metastatic NSCLC who have not received prior treatment with an ALK inhibitor. Results from the trial showed ALUNBRIG demonstrated superiority compared to crizotinib with significant responses observed in patients with baseline brain metastases. After more than two years of follow-up, ALUNBRIG reduced the risk of disease progression or death by 76% (hazard ratio [HR] = 0.24, 95% CI: 0.12-0.45) in newly diagnosed patients whose disease had spread to the brain, as assessed by investigators. ALUNBRIG also demonstrated consistent overall efficacy (intent to treat population), with a median progression-free survival (PFS) three times longer than that with crizotinib at 29.4 months (95% CI: 21.2-NE) versus 9.2 months (95% CI: 7.4-12.9), as assessed by investigators.
Because of the complex nature of ALK+ NSCLC and the way in which the disease often spreads to the brain, it is essential for physicians to have treatment options that demonstrate both overall and intracranial effectiveness
The safety profile of ALUNBRIG in the ALTA-1L trial was generally consistent with the existing European summary of product characteristics (SmPC). The most common treatment-emergent adverse events (TEAEs) Grade ≥3 in the ALUNBRIG arm were increased CPK (24.3%), increased lipase (14.0%) and hypertension (11.8%); and for crizotinib were increased ALT (10.2%), increased AST (6.6%), and increased lipase (6.6%).
“Developing safe and effective treatment options for cancer is a top priority for Takeda, and we continue to look for ways to address the unmet needs of the lung cancer community,” said Christopher Arendt, Head, Oncology Therapeutic Area Unit, Takeda. “Today’s positive CHMP opinion is an important step towards bringing ALUNBRIG to people living with ALK+ advanced NSCLC, and we look forward to continuing to work with the EMA as they review the application for ALUNBRIG as a first-line treatment of patients with this serious and rare form of lung cancer.”
“ALK+ NSCLC is a rarer form of lung cancer, and the needs of people impacted by it are multiple,” said Stefania Vallone, President of Lung Cancer Europe (LuCE). “Despite progress in recent years, there remains a need for additional first-line treatment options for the approximately 10,000 people with ALK+ NSCLC in Europe.”
The positive opinion for ALUNBRIG will now be reviewed by the European Commission (EC) for Commission Decision. ALUNBRIG is currently not approved as a therapy for first-line ALK+ NSCLC.