FDA Approves FoundationOne Liquid CDx for Mobocertinib in NSCLC

The FDA has approved the FoundationOne Liquid CDx assay as a companion diagnostic for identifying patients who may be eligible for treatment with mobocertinib (Exkivity) for locally advanced or metastatic non–small cell lung cancer (NSCLC) harboring EGFR exon 20 insertion mutations that has progressed on or following platinum-based chemotherapy, according to a press release from Foundation Medicine.¹

The FDA previously approved FoundationOne Liquid CDx for identifying patients with NSCLC harboring EGFR exon 19 deletions or exon 21 L858R substitutions who may benefit from treatment with FDA-approved tyrosine kinase inhibitors in December 2022.

Mobocertinib received accelerated approval from the FDA as a treatment in this patient population in September 2021 based on overall response rate (ORR) and duration of response (DOR) data from the phase 1/2 Study 101 (NCT02716116).² The ORR was 28% (95% CI, 20%-37%), and the median DOR was 17.5 months (95% CI, 7.4-20.3) with mobocertinib based on assessments by an independent review committee.

“EGFR exon 20 insertion-positive NSCLC is a rare and historically underdiagnosed disease that requires a targeted treatment approach at the molecular level due to its unique mutation,” Stefanie Granado, head of the U.S Oncology Business Unit at Takeda, said in the press release. “The approval of this indication for [FoundationOne Liquid CDx] is another important step forward to expand the identification of patients in the U.S. with this rare cancer and improve access for people who may benefit from treatment with [mobocertinib], including those unable to undergo tumor biopsy.”

The FoundationOne Liquid CDx was designed to analyze 324 genes via circulating cell-free DNA and report short variants across 311 genes, which helps identify patients who may be suitable to receive treatment with specific therapies in accordance with product labelling. According to its manufacturers, the test is for prescription use only, and testing of plasma is only appropriate in the absence of available tumor tissue. Confirming mutation status using an FDA-approved tumor tissue test is suitable if patients have negative results for other companion diagnostic mutations.

The press release advised that the FoundationOne Liquid CDx assay may detect additional genomic findings that are not prescriptive for labeled use of any approved therapy. Additionally, the test does not guarantee the matching of a patient to an appropriate treatment, and a negative reading does not negate the presence of a genomic alteration.

The FDA previously approved FoundationOne Liquid CDx for identifying patients with NSCLC harboring EGFR exon 19 deletions or exon 21 L858R substitutions who may benefit from treatment with FDA-approved tyrosine kinase inhibitors (TKIs) including erlotinib (Tarceva) and osimertinib (Tagrisso) in December 2022.³ The FDA also approved the FoundationOne CDx as a companion diagnostic for identifying those who are eligible to receive TKIs for NSCLC with EGFR exon 19 deletions or exon 21 alterations in March 2022.⁴

“People living with rare forms of lung cancer like EGFR exon 20 insertion mutated NSCLC often face limited treatment options. It’s encouraging to see continued progress toward improving access to new treatment options for patients living with advanced [NSCLC],” Danielle Hicks, chief patient officer at GO2 for Lung Cancer, concluded.

References

1. FoundationOne®Liquid CDx receives FDA-approval as a companion diagnostic for EXKIVITY® (mobocertinib) to identify patients with EGFR exon 20 insertion mutations in advanced non-small cell lung cancer. News release. Foundation Medicine. May 4, 2023. Accessed May 4, 2023. bit.ly/3p48NpT
2. FDA grants accelerated approval to mobocertinib for metastatic non-small cell lung cancer with EGFR exon 20 insertion mutations. News release. FDA. September 16, 2021. Accessed May 4, 2023. bit.ly/416RK3Z
3. Foundation Medicine receives FDA approval for FoundationOne®Liquid CDx as a companion diagnostic for a certain group of tyrosine kinase inhibitors for treatment of non-small cell lung cancer patients. News release. Foundation Medicine. December 21, 2022. Accessed May 4, 2023. bit.ly/3jpU6uE
4. U.S FDA approves FoundationOne®CDx as a companion diagnostic for EGFR therapeutics targeting exon 19 deletions of exon 21 substitutions in non–small cell lung cancer. News Release. March 17, 2022. Accessed May 4, 2023. https://bit.ly/3wfLUS6