Takeda announced that EXKIVITY® (mobocertinib) has been approved by the National Medical Products Administration (NMPA) of China for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) Exon20 insertion mutations, whose disease has progressed on or after platinum-based chemotherapy. EXKIVITY has shown clinically meaningful and durable responses in patients with locally advanced or metastatic EGFR Exon20 insertion+ NSCLC and is now the first and only treatment available for this patient population in China. EXKIVITY, an oral tyrosine kinase inhibitor designed to target Exon20 insertions, was reviewed as part of the NMPA's Breakthrough Therapy program.

Full approval for this indication may be contingent upon verification of clinical benefit in a confirmatory trial. This approval is based on the results from the platinum-pretreated population in the Phase 1/2 trial of EXKIVITY, which consisted of 114 patients with EGFR Exon20 insertion+ NSCLC who received prior platinum-based therapy and were treated at the 160 mg dose. Results demonstrated a confirmed ORR of 28% per IRC as well as a median DoR of 15.8 months per IRC, a median overall survival (OS) of 20.2 months and a median progression-free survival (PFS) of 7.3 months per IRC.

The most common treatment-related adverse reactions (TRAEs) were diarrhea (92%), rash (46%), paronychia (38%) and decreased appetite (37%). EXKIVITY is a first-in-class, oral tyrosine kinase inhibitor (TKI) specifically designed to selectively target epidermal growth factor receptor (EGFR) Exon20 insertion mutations. EXKIVITY is currently approved in the United States, Great Britain, Switzerland, South Korea, Australia and China for the treatment of adult patients with locally advanced or metastatic NSCLC with EGFR Exon20 insertion mutations, whose disease has progressed on or after platinum-based chemotherapy.