Exkivity Withdrawn: Takeda Takes Action Globally After Confirmatory Trial Disappointment

Takeda, on Monday, announced that it will be voluntarily withdrawing its non-small cell lung cancer drug Mobocertinib, marketed in the US as Exkivity from the United States. According to the Japanese pharmaceutical major, the decision was taken after discussions with the U.S. Food and Drug Administration (FDA).

Along similar lines, the company is also planning for a voluntary withdrawal globally in countries where Exkivity is approved and is working with regulators in those countries. Apart from the US, the drug was approved in Switzerland, Australia, South Korea, and China. 

It is to be noted that Exkivity had received an accelerated approval in 2021. One of the conditions put forth by the FDA for the accelerated approval of the drug was progression-free survival data from a randomized trial to test the drug’s clinical benefit.

Takeda took its latest decision of withdrawal as the Phase 3 EXCLAIM-2 confirmatory trial did not meet its primary endpoint, thus failing to meet the confirmatory data requirements of the accelerated approval granted by the U.S. FDA. Furthermore, the trial did not fulfill the conditional marketing approvals granted in other countries as well. 

Last July, Takeda announced that the study had been put on hold due to futility as it was not likely to meet its goal. To add on, the company had also withdrawn its application for marketing authorization in the European Union in 2022.

Following its latest announcement, Takeda’s U.S.-listed shares witnessed a fall of about 6% to $14.39. On Monday, the company said that it will continue to evaluate the impact of Exkivity’s withdrawal and update its annual forecast for the fiscal year ending March 31, 2024.

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A Phase 3, multicenter, open-label study, the late-stage trial investigated the safety and efficacy of Exkivity as a monotherapy versus a type of chemotherapy in patients who had non-small cell lung cancer (NSCLC). There were no new safety signals observed in the EXCLAIM-2 trial. As per the company, the full data from the trial will be revealed in a forthcoming medical meeting or published in a peer-reviewed journal.

According to the World Health Organization, non-small cell carcinoma (NSCLC) is a common type of lung cancer. Of the estimated 2.2 million new cases of lung cancer diagnosed each year globally, 85% of them are NSCLC. When compared to Western populations, this type of cancer is found more commonly in Asian populations. Of the patients diagnosed with NSCLC, around 1-2% constitute those with epidermal growth factor receptor (EGFR) Exon20 insertion mutation-positive (insertion+) NSCLC. 

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A first-in-class, oral tyrosine kinase inhibitor (TKI), Exkivity is designed to selectively target epidermal growth factor receptor (EGFR) Exon20 insertion mutations. The drug received approval based on its results from the platinum-pretreated population in the Phase 1/2 trial in patients suffering from EGFR Exon20 insertion mutation-positive (insertion+) metastatic non-small cell lung cancer (NSCLC). 

Awny Farajallah, MD, head of Global Medical Affairs Oncology at Takeda said that it was the company’s steadfast commitment to discover solutions for people with high unfulfilled needs that led them to come up with EXKIVITY as the first oral therapy designed for patients with EGFR Exon20 insertion+ metastatic NSCLC.

He went on to say that they have been fortunate to witness the impact the drug has had on this previously underserved population and are motivated to see the progress made since its approval to launch new therapies for these patients. Farajallah also expressed hope that findings from the EXCLAIM-2 study will fuel future research and development for NSCLC.

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