Two Lung Cancer Drugs from Janssen and Takeda Nominated for Breakthrough Therapy Designation in China

On September 29, the CDE updated its list of proposed Breakthrough Therapy designations, with two imported new drugs included: TAK-788 capsules from Takeda Pharmaceutical Company Limited and the bispecific antibody JNJ-61186372 from Janssen Pharmaceuticals.

TAK-788 Capsules

TAK-788 is an orally active small-molecule inhibitor that selectively targets EGFR and HER2 mutations while sparing wild-type EGFR. It is the first novel agent specifically designed to target EGFR exon 20 insertion (EGFR 20ins) mutations, demonstrating breakthrough efficacy. Phase 1/2 studies have confirmed that TAK-788 exhibits robust antitumor activity and a manageable safety profile in patients with previously treated non-small cell lung cancer (NSCLC) harboring EGFR 20ins mutations.

According to the Insight database, TAK-788 has currently been registered for 10 clinical trials globally and has received approval for two clinical trials in China for the treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring EGFR exon 20 insertion mutations. Previously, the U.S. FDA had granted TAK-788 orphan drug designation and breakthrough therapy designation.

EGFR/cMET Bispecific Antibody JNJ-61186372

JNJ-61186372 is a bispecific antibody targeting EGFR and cMET, developed by Janssen Pharmaceuticals. It is currently undergoing multiple clinical trials globally for lung cancer and other solid tumors.

The indication proposed for inclusion in the Breakthrough Therapy designation is for the treatment of patients with metastatic or surgically unresectable non-small cell lung cancer (NSCLC) harboring EGFR exon 20 insertion mutations, who have progressed during or after platinum-based doublet chemotherapy, or who are intolerant to platinum-based chemotherapy.

JNJ-61186372: In March this year, the drug was granted Breakthrough Therapy Designation by the U.S. FDA for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) harboring EGFR exon 20 insertion mutations whose disease progressed during or after platinum-based chemotherapy.

Insight database shows that Janssen is currently conducting a Phase I clinical trial in China to evaluate the safety, pharmacokinetics (PK), exploratory Phase II recommended dose, and preliminary efficacy of JNJ-61186372 in patients with advanced non-small cell lung cancer. The proposed designation as a breakthrough therapy is expected to accelerate the development of this new drug in China and shorten the time to market approval.