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Mobocertinib (Exkivity) after a failed confirmatory trial in non-small cell lung cancer (NSCLC) patients with EGFR exon 20 insertion mutations, drugmaker Takeda announced.

In the phase III , monotherapy treatment with the EGFR inhibitor showed no significant benefit over platinum-based chemotherapy as first-line therapy for NSCLCs harboring EGFR exon 20 insertion mutations. These mutations are associated with rapid tumor growth and occur in roughly 2% to 3% of NSCLC patients.

"We have been fortunate to witness the impact Exkivity has had on this previously underserved population and are encouraged to see the advancements made since its approval to introduce new therapies for these patients," said Awny Farajallah, MD, the head of Global Medical Affairs Oncology at Takeda. "We hope that findings from the EXCLAIM-2 study will inform future research and development for this disease."

Takeda said it intends to initiate similar withdrawals from markets across the globe.

The first-in-class EGFR inhibitor had been FDA approved under the accelerated pathway in 2021 for patients previously treated with platinum-based chemotherapy based on a single-arm study. In that trial, 28% of patients responded to the tyrosine kinase inhibitor, and the median duration of response reached 17.5 months.

But as a condition of the speedy approval, the company needed to demonstrate a progression-free survival benefit in the open-label EXCLAIM-2 study. Takeda said that no new safety signals were identified in the trial, and that full results will be presented at a meeting or published in a journal.

As alluded to, mobocertinib isn't the only approved drug for NSCLC patients with EGFR exon 20 insertion mutations. The FDA in 2021 granted accelerated approval to the bispecific antibody amivantamab (Rybrevant) for the same indication. It appears that drug will stay on the market, as just last week amivantamab-maker Johnson & Johnson confirmed the benefit in newly diagnosed NSCLC.

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