Takeda plans withdrawal of lung cancer therapy Exkivity from U.S. market
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Takeda will work with the FDA toward voluntary withdrawal of its lung cancer therapy mobocertinib from the U.S. market, according to a company press release.
Takeda — which intends to initiate similar voluntary withdrawals in other parts of the world where the therapy is approved — made the decision after a required phase 3 confirmatory trial failed to meet its primary endpoint.
The FDA granted accelerated approval in September 2021 to mobocertinib (Exkivity, Takeda) — an oral tyrosine kinase inhibitor designed to target EGFR exon 20 insertion mutations — for treatment of adults with locally advanced or metastatic EGFR exon 20 insertion-positive non-small cell lung cancer whose disease progressed on or after platinum-based chemotherapy.
As Healio reported at the time, the agency based approval on results of a phase 1/phase 2 trial that included 114 patients with EGFR exon 20 insertion-positive NSCLC who received prior platinum-based therapy.
Mobocertinib induced a confirmed overall response rate of 28% per independent review committee assessment. Results showed median duration of response of 17.5 months, median OS of 24 months and median PFS of 7.3 months.
The accelerated approval required confirmatory data.
In the randomized phase 3 EXCLAIM-2 trial, researchers compared the efficacy and safety of mobocertinib monotherapy vs. platinum-based chemotherapy as first-line treatment for patients with EGFR exon 20 insertion-positive locally advanced or metastatic NSCLC.
The trial failed to achieve its primary endpoint of improved PFS per independent review committee assessment.
Complete data from EXCLAIM-2 will be presented at a medical meeting or published in a peer-reviewed journal, according to a Takeda press release.
“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,” Awny Farajallah, MD, head of global medical affairs for oncology at Takeda, said in the release. “We hope that findings from the EXCLAIM-2 study will inform future research and development for this disease.”
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