Takeda Pharmaceuticals USA has tapped Roche’s Foundation Medicine to develop tissue- and blood-based companion diagnostic tests for its portfolio of therapies for metastatic and late-stage lung cancers.
This includes a genomic test to determine if patients would benefit from Alunbrig (brigatinib), a tyrosine kinase inhibitor that received an expanded FDA approval this past May for people with anaplastic lymphoma kinase-positive, or ALK-positive metastatic non-small cell lung cancer, an aggressive form of the disease.
Previously approved for cases where other treatments have failed, Alunbrig’s use was broadened by the agency this year to include previously untreated patients. There it will compete with Roche’s Alecensa, Novartis’ Zykadia and Pfizer’s Xalkori.
The collaboration also includes Takeda’s mobocertinib (TAK-788), which is being studied as a potential first-in-class treatment for a subset of people with metastatic non-small cell lung cancer, containing epidermal growth factor receptor exon 20 insertion mutations, which occur in about 1% to 2% of patients and have no targeted treatment options.
The tyrosine kinase inhibitor received a breakthrough designation from the FDA earlier this year following the benefits seen in an early-stage study in patients that had previously undergone chemotherapy.
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In late August, the FDA approved Foundation Medicine’s liquid biopsy test, FoundationOne Liquid CDx, giving oncologists the ability to profile the genomic mutations within any solid tumor through a simple blood draw. The test reports more than 300 alterations in cancer-related genes, plus measures of tumor mutational burden and microsatellite instability.
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It was also approved as a companion diagnostic for three tyrosine kinase inhibitors for non-small cell lung cancer—AstraZeneca’s Iressa and Tagrisso, and Genentech’s Tarceva—as well as for Clovis Oncology’s Rubraca in metastatic, castration-resistant prostate cancer with BRCA1 and BRCA2 alterations. Now, FoundationOne Liquid CDx, as well as the tissue-based FoundationOne CDx, will be specifically developed for Takeda’s therapies.