Takeda's next-generation targeted drug, Arunbrig, has been approved with the support of the European Union's CHMP

Takeda, the Japanese pharmaceutical giant, recently announced that the European Medicines Agency(EMA) Human Pharmaceutical Products Committee (CHMP) has issued a positive opinion recommending the full approval of Brigabrig as a single-drug therapy for the treatment of advanced mesolytic lymphoma kinase (ALK plus) advanced non-small cell lung cancer (NSCLC) adult patients who have previously received Xalkori (crizotinib) treatment.
chMP's advice will be submitted to the European Commission (EC), which usually takes CHMP's recommendations when making a final review decision, meaning that Alunbrig is likely to receive full EU approval in the next 2-3 months. If approved, Alunbrig would be the first and only APK inhibitor in Europe to take one tablet of ALK daily or mouth with food or different medications.
positive opinion of CHMP is based on a global, group 2, open label, multi-center Phase II clinical study alTA positive data. The study was conducted in 222 adult patients with localized late stage or metastasis ALC-NSCLC who had previously received Xalkori treatment for progression. In the study, patients were randomly assigned to receive a daily dose of 90 mg of Alunbrig (n=112) or a daily dose of 180 mg of Arunbrig (n=110, once a day during the 7-day import period of 90 mg, followed by a daily dose of 180 mg). The main endpoints are the objective mitigation rate (ORR) assessed by the researchers based on RESIST v1.1, and other key endpoints include ORR, mitigation duration (DOR), progress-free lifetime (PFS), intracranial ORR, intracranial DOR, total lifetime (OS), safety and tolerance assessed by the Independent Review Commission (IRC).
data showed that the 180mg treatment group had a 56% ORR, a medium DOR of 13.8 months, a medium PFS of 15.6 months, an IRC of 56%, a medium DOR of 15.7 months and a medium PFS of 16.7 months. In addition, in patients with brain metastasis at the baseline , the intracranial ORR assessed by the IRC was 67% and the intracranial DOR was 16.6 months, while the researchers assessed the medium OS as 34.1 months.
it is worth noting that the 16.7-month-long mid-PFS assessed by the IRC is also by far the longest reported medium PFS in the group of patients with ALC-NSCLC who progressed after Xalkori treatment.
as part of the Listing Permit Application (MAA), CHMP also reviewed the first interim analysis data from Phase III clinical study ALTA-1. The study, conducted in patients with local late stage or metastasis APK-NSCLC who had not previously been treated with ALC inhibitors, assessed the efficacy and safety of Alunbrig (90 mg once a day during the import period and 180 mg once a day after the introduction period) relative to Xalkori (250 mg, 2 times a day) for first-line treatment. The data showed that the study reached its main end point: Alunbrig achieved a statistically significant extension of PFS compared to Xalkori. In this study, Alunbrig's security is consistent with previous studies.
ALC is the second therapeutic target found in NSCLC and is present in about 3% to 5% of NSCLC patients, especially young adenocarcinoma patients who do not smoke. These patients' APK genes tend to fuse with other genes to produce APK fusion proteins, a mutation that causes tumors to grow. Xalkori is the world's first ALC targeted treatment drug developed by Pfizer, and its launch has dramatically changed the clinical treatment of patients with advanced ALC-NSCLC, but deterioration is often inevitable, and when tumors do not respond to Xalkori, there is little treatment option. Alunbrig is a new generation of APK inhibitors that inhibit the growth of tumors by inhibiting APK and APK fusion proteins. (Bio Valley)