Bayer has secured a major regulatory win in China, with the National Medical Products Administration (NMPA) approving its targeted cancer drug sevabertinib as a first-line treatment for adults with advanced HER2-mutated non-small cell lung cancer (NSCLC).

 

The approval covers adult patients with unresectable, locally advanced or metastatic NSCLC whose tumours carry HER2 (ERBB2) activating mutations, opening up a new first-line treatment option for this distinct group of lung cancer patients.

 

Sevabertinib is an oral, reversible, small-molecule tyrosine kinase inhibitor (TKI) designed to target HER2-activating mutations.

 

The latest decision marks another step forward for precision oncology in China, particularly for patients with HER2-mutated lung cancer, a subtype that can affect people who have never smoked.

 

“Lung cancer remains the leading cause of cancer-related deaths worldwide. For patients in China with HER2-mutated NSCLC, a distinct subtype that often affects people who have never smoked, this approval represents meaningful progress,” said Christian Rommel, Head of Research and Development at Bayer’s Pharmaceuticals Division.

 

“The NMPA’s approval of sevabertinib as a first-line therapy for the treatment of adult patients with unresectable, locally advanced or metastatic NSCLC underscores Bayer's continued commitment to precision oncology. This milestone reflects the progress being made in expanding access to precision medicines and bringing forward treatments tailored to the specific molecular characteristics of each patient’s tumor.”

 

The NMPA's decision was based on clinical data demonstrating the drug's objective response rate (ORR) and duration of response (DOR) in a treatment-naïve cohort of 73 patients enrolled in the ongoing Phase I/II SOHO-01 trial.

 

The trial, which is evaluating the efficacy and safety of sevabertinib in patients with locally advanced or metastatic HER2-mutant NSCLC, reported an objective response rate of 75%. Complete responses were observed in 6% of patients, while 70% achieved partial responses. Among those who responded to treatment, 73% maintained their response for at least six months.

 

The drug's safety profile was consistent with previously reported findings.

 

However, continued approval for this indication may depend on confirmation and further description of clinical benefit through the ongoing Phase III SOHO-02 trial. The study is comparing sevabertinib with standard-of-care treatment in previously untreated patients with advanced HER2-mutant NSCLC.