Takeda to withdraw lung cancer drug Exkivity following FDA talks

03 Oct 2023
firstwordpharma.com
Phase 3Clinical ResultNDA
Takeda disclosed Monday that following discussions with the FDA, it will be working with the agency to voluntarily withdraw Exkivity (mobocertinib) in the US for certain previously treated patients with advanced non-small-cell lung cancer (NSCLC). It plans to do the same elsewhere globally, and is working with regulators in other countries on next steps.
The FDA granted the tyrosine kinase inhibitor an accelerated approval in 2021 for locally advanced or metastatic non-small-cell lung cancer (NSCLC) in adults with EGFR exon20 insertion mutations, whose disease progressed on or after platinum-based chemotherapy. That decision was backed by results from the platinum-pretreated cohort of a Phase I/II trial demonstrating a confirmed objective response rate (ORR) of 28% per independent review committee, as well as a duration of response of 17.5 months.
Failed confirmatory trial
According to Takeda, the decision to pull the drug from the market was based on the outcome of the Phase III EXCLAIM-2 trial, which did not achieve its primary endpoint, falling short of confirmatory data requirements for the accelerated US nod as well as conditional marketing approvals granted in other countries. EXCLAIM-2 was designed to evaluate Exkivity monotherapy versus platinum-based chemotherapy in first-line EGFR exon20 insertion-positive locally advanced or metastatic NSCLC. There were no new safety signals in the trial, whose full results Takeda plans to share at an upcoming medical meeting or publish in a peer-reviewed journal.
"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, head of global medical affairs for oncology at the Japanese drugmaker, adding "we hope that findings from the EXCLAIM-2 study will inform future research and development for this disease."
Johnson & Johnson recently reported that its bispecific antibody Rybrevant (amivantamab-vmjw) met the primary endpoint of progression-free survival in the Phase III MARIPOSA-2 trial of EGFR-mutated lung cancer patients. That drug, which targets the EGFR and MET oncogenes, received accelerated approval from the FDA in 2021 for a similar NSCLC patient population based on Phase I results showing a 40% ORR.
Takeda stated it will continue to assess the impact of the Exkivity withdrawal and update its outlook for the fiscal year ending March 31 next year, if necessary.
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