Innovent's Limertinib, a Third-gen EGFR TKI, Approved in China for First-line Lung Cancer Treatment

Innovent Biologics, a prominent biopharmaceutical company, recently announced that China's National Medical Products Administration (NMPA) has approved the New Drug Application (NDA) for limertinib. This approval marks limertinib's use as a first-line treatment for adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) carrying specific EGFR mutations, namely exon 19 deletions or exon 21 L858R mutations. This development highlights a significant advancement in NSCLC treatment options within China.

The authorization for limertinib's new medical indication draws on compelling data from a well-structured Phase 3 clinical trial. This trial enrolled 337 patients who had not received prior treatment and had NSCLC with EGFR-sensitive mutations. These patients were randomly assigned to receive either limertinib or gefitinib, with the primary evaluation metric being progression-free survival (PFS). An independent review committee assessed these outcomes.

The results demonstrated that limertinib notably extended the median PFS compared to gefitinib, showing 20.7 months versus 9.7 months, thereby illustrating a 56% reduction in the risk of disease progression or death. Limertinib also exhibited significant efficacy in patients with central nervous system (CNS) metastases, achieving a median CNS PFS of 20.7 months compared to 7.1 months with gefitinib. This corresponds to a 72% decrease in the risk of CNS disease progression or death, underscoring limertinib's potent intracranial activity.

Limertinib's safety profile aligns with existing EGFR-targeted therapies, where adverse effects were mainly mild to moderate, ensuring tolerability among patients. The complete analysis and data from this pivotal Phase 3 study are slated for publication in leading academic journals, signifying its importance to the medical community.

Professor Shi Yuankai, a leading oncologist at the Chinese Academy of Medical Sciences and principal investigator of this study, highlighted limertinib's remarkable efficacy and safety profile. He emphasized its effectiveness as a first-line therapy, particularly for patients with brain metastases, providing a vital new treatment option for the Chinese population with specific NSCLC mutations.

Dr. Hui Zhou, Innovent's Senior Vice President, expressed enthusiasm over the successive approvals of limertinib's indications for both first-line and second-line treatments. As a next-generation EGFR TKI, limertinib is poised to enhance survival outcomes for patients with mutation-positive NSCLC. Innovent's portfolio includes precision therapies like limertinib, Retsevmo®, Dupert®, and DOVBLERON®, with efforts underway to maximize their synergistic benefits. The company aims to collaborate closely with Ask Pharm in ensuring limertinib becomes widely accessible to patients with EGFR-mutated NSCLC.

Furthermore, Mr. Jingfei Ma, CEO of ASK Pharm, noted that the approval of limertinib for first-line use extends its clinical utility. ASK Pharm is also exploring a trial combining limertinib with the cMET inhibitor ASKC202 for NSCLC patients resistant to third-generation EGFR-TKIs, with hopes of broadening limertinib's reach to more patients.

Lung cancer remains a leading cause of cancer-related deaths worldwide, with NSCLC constituting around 85% of cases. A significant proportion of NSCLC patients are diagnosed at advanced stages unsuitable for surgery. EGFR mutations are prevalent among Asian patients, impacting 30% to 50% of cases, making EGFR-TKIs the recommended first-line therapy.

Limertinib, an orally-administered, third-generation EGFR TKI, is designed to target these mutations effectively. It has secured regulatory approval for treating adult patients with locally advanced or metastatic NSCLC with specific EGFR mutations, solidifying its status as a critical component in precision oncology.

Innovent, established in 2011, is committed to delivering high-quality biopharmaceuticals globally. The company focuses on innovative therapies for cancer, cardiovascular, metabolic, autoimmune, and ophthalmologic diseases, with a robust pipeline of products in various stages of development and regulatory review.