Takeda’s Courageous Decision: Navigating Challenges as Lung Cancer Drug Falls Short in Confirmatory Trial

Takeda has taken a tough but necessary decision to withdraw its lung cancer drug, mobocertinib, known as Exkivity, from both U.S. and global markets. This move comes on the heels of disappointing results from a Phase III trial that dashed hopes of meeting the primary endpoint.

In the wake of these findings and after discussions with the FDA, Takeda has chosen to pull the drug from the U.S. market. Furthermore, the company has expressed its intent to initiate a global voluntary withdrawal of Exkivity in regions where it had been approved.

However, Takeda is not turning its back on patients currently receiving Exkivity. The company is actively working with healthcare providers to ensure that patients can continue to access the drug as appropriate.

The story of Exkivity began with a ray of hope when it received priority review status from the FDA back in April 2021. This was based on promising results from a Phase I/II trial involving patients with epidermal growth factor receptor (EGFR) Exon20 insertion mutation-positive non-small cell lung cancer (NSCLC). The initial study showed an overall response rate of 28% and a median overall survival of 24 months, making Exkivity the only approved oral therapy for this specific mutation.

While NSCLC is the most common form of lung cancer globally, patients with EGFR Exon20 insertion mutations represent only a small fraction, accounting for 1% to 2% of NSCLC cases. Unfortunately, these patients typically face a bleaker prognosis compared to others with EGFR mutations.

The Exclaim-2 Trial was expected to validate these initial results and potentially expand Exkivity’s use as a second-line treatment, as well as explore its potential as an alternative to platinum-based chemotherapy in the first-line setting. Takeda had even projected peak revenues as high as $600 million if the drug received first-line approval.

As Takeda navigates the aftermath of this withdrawal, it remains committed to evaluating the impact and will provide updates to its full-year forecast as necessary.

Awny Farajallah, head of global medical affairs oncology at Takeda, acknowledged the significance of Exkivity in serving an underserved patient population. Despite this setback, he expressed hope that the findings from the EXCLAIM-2 study would contribute to future research and development efforts for this challenging disease.

Regrettably, this isn’t the only recent disappointment for Takeda. Their investigational enzyme replacement therapy, TAK-611, faced setbacks, failing to meet primary and secondary endpoints in a Phase II study. As a result, this drug program is likely to be discontinued.

TAK-611 had been in development for metachromatic leukodystrophy (MLD), a rare genetic disorder characterized by the accumulation of lipids in cells, particularly in the nervous system, leading to the progressive loss of organ function.

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