Takeda's Mobocertinib Capsules Under Priority Review in China for EGFR Exon20 Insertion-Positive NSCLC

Source: Yiyao Guanlan

According to the latest public disclosure by the Center for Drug Evaluation (CDE) of China's National Medical Products Administration (NMPA), Takeda’s investigational therapy, mobocertinib capsules, is proposed for priority review as a “drug eligible for conditional approval.” The indication is for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring epidermal growth factor receptor (EGFR) exon 20 insertion mutations who have previously received chemotherapy. Publicly available information indicates that mobocertinib is a potential “first-in-class” oral therapy specifically designed to selectively target EGFR exon 20 insertions. It has previously been granted Breakthrough Therapy Designation in China and has also received Priority Review designation and Breakthrough Therapy designation from the FDA.

Screenshot source: CDE official website

Publicly available data indicate that mobocertinib is a potent oral small-molecule tyrosine kinase inhibitor (TKI) specifically designed to selectively target EGFR exon 20 insertion mutations. The clinical efficacy of mobocertinib in treating patients with EGFR exon 20 insertion-positive NSCLC has been preliminarily demonstrated in a phase 1/2 clinical trial. The study enrolled 114 patients with metastatic NSCLC who had previously received platinum-based chemotherapy.

The results showed that, according to the Independent Review Committee (IRC) assessment, mobocertinib achieved a confirmed objective response rate (ORR) of 28%, a median duration of response (DoR) of 17.5 months, a median progression-free survival (PFS) of 7.3 months, and a disease control rate (DCR) of 78%.

In this trial, mobocertinib demonstrated clinically meaningful responses and a significant duration of response. Based on these study results, the FDA granted Priority Review designation for the New Drug Application (NDA) of mobocertinib in late April 2021, for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) harboring EGFR exon 20 insertion mutations who had previously received platinum-based chemotherapy.

Among patients with non-small cell lung cancer (NSCLC), those with metastatic NSCLC positive for EGFR exon 20 insertions account for approximately 1–2%. This disease subtype is more prevalent in Asian populations. These patients have a poorer prognosis compared to individuals with other EGFR mutations. Currently, there are no approved targeted therapies specifically indicated for this genetic alteration, and existing EGFR tyrosine kinase inhibitors (TKIs) and chemotherapy offer limited clinical benefit. Consequently, these patients face inferior survival outcomes and have an urgent unmet need for novel targeted treatment options.

Note: The original text has been abridged.

References:

[1] Center for Drug Evaluation, National Medical Products Administration. Retrieved May 25, 2021, from http://www.cde.org.cn/news.do?method=changePage&pageName=service&frameStr=25#

[2] Takeda Announces U.S. FDA Grants Priority Review for New Drug Application for Mobocertinib (TAK-788) as a Treatment for EGFR Exon20 Insertion+ Metastatic Non-Small Cell Lung Cancer. Retrieved April 27, 2021, from https://www.businesswire.com/news/home/20210427006162/en

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