Bayer moves Hyrnuo into frontline lung cancer treatment

 Bayer has won FDA approval for oral HER2 inhibitor Hyrnuo as a first-line treatment for advanced HER2-mutant non-small cell lung cancer (NSCLC), just a year after it was cleared as a second-line option.

Hyrnuo (sevabertinib) has been cleared for earlier use on the strength of interim data from the ongoing phase 1/2 SOHO-01 trial, which revealed an objective response rate (ORR) of 75% with the drug, including 6% complete responses and partial responses in nearly 70% of patients with HER2+ non-squamous NSCLC.

The expanded label puts Bayer's drug on an even playing field as it competes with Boehringer Ingelheim's rival oral HER2 inhibitor Hernexeos (zongertinib), which was approved as a second-line option for this type of lung cancer last year.

Hernexeos also moved into the frontline setting in February, based on the Beamion LUNG-1 study, after a double-quick review under the FDA's national priority voucher programme.

The two drugs offer very similar levels of efficacy in their supporting trials, but the safety data seems to lend a competitive edge to Boehringer's drug, which seems to have lower levels of toxicity in general and a lower rate of severe diarrhoea in particular, which could result in improved patient adherence and quality of life.

Analysts at GlobalData think sales of both drugs will be fairly modest in the next few years, predicting that Hernexeos will make around $54 million in seven major markets – France, Germany, Italy, Japan, Spain, the UK, and the US – by 2032, with Hyrnuo a little behind at $49 million.

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

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.

HER2 mutations are seen in between 2% and 4% of NSCLC patients, and are associated with a poor prognosis and a higher incidence of the cancer spreading to the brain. Patients with HER2-mutant NSCLC are predominantly women, and tend to be younger and non-smokers.

Bayer has estimated that up to 84,000 people are diagnosed with HER2-positive NSCLC globally each year.

"Lung cancer remains the leading cause of cancer-related deaths worldwide, and for patients with HER2-mutated NSCLC, a distinct subtype that often affects people who have never smoked, there remains a critical need for additional treatment options," said Bayer's head of global product strategy and commercialisation, Christine Roth.

"This approval underscores the potential of precision medicine to transform outcomes by matching the right patients to the right therapy at the right time."

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