Bayer's Hyrnuo moves first-line for lung cancer in China

Bayer's oral HER2 inhibitor Hyrnuo has been approved in China as a frontline therapy for advanced, HER2-mutant non-small cell lung cancer (NSCLC), just a few months after it was cleared there for previously treated patients.

This is the third approval for Hyrnuo (sevabertinib) in the first-line setting, after the US and Japan, and is based on the results of the ongoing phase 1/2 SOHO-01 trial, which was a highlight of last year's ESMO cancer congress.

Bayer is in a closely fought contest with Boehringer Ingelheim in the oral HER2 category, and the new approval brings Hyrnuo into line with the latter's Hernexeos (zongertinib) product, which was cleared in China for previously untreated HER2-mutant NSCLC in May and as a second-line therapy in 2025.

The expansion of Hyrnuo's label to include first-line use in China stems from a cohort of 73 previously untreated patients in SOHO-01. Results from this subgroup showed an objective response rate (ORR) of 75%, including 6% complete responses and partial responses in 70% of patients. In almost three-quarters of responders, the tumour response was maintained for at least six months.

Hernexeos' move into the frontline setting was based on results from the Beamion LUNG-1 study, which showed similar response rates.

Lung cancer is a major public health problem in China, ranking as the leading cause of both cancer incidence and mortality.

HER2 mutations – which often signal a poor prognosis and limited treatment options – are found in somewhere between 2% and 4% of patients with NSCLC overall, with some estimates suggesting that the rate in China is a little higher than in Western patient populations.

"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 R&D at Bayer’s pharma division.

"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 tumour."

Both Bayer and Boehringer are running confirmatory trials – respectively, SOHO-02 and Beamion LUNG-2 – to try to convert conditional approvals for their drugs to full approvals.

Meanwhile, Boehringer is also running the Beamion LUNG-3 trial of Hernexeos as adjuvant monotherapy for early-stage HER2+ NSCLC, while Bayer's panSOHO study is focusing on advanced, non-NSCLC solid tumours expressing HER2.