Bayer takes on Boehringer with FDA nod for lung cancer drug

The FDA has given accelerated approval to Bayer for oral HER2 tyrosine kinase inhibitor sevabertinib as a second-line treatment for advanced HER2-mutant non-small cell lung cancer (NSCLC), allowing it to challenge Boehringer Ingelheim's recently approved Hernexeos.

Sevabertinib – now given the US trade name of Hyrnuo – can be used to treat locally advanced or metastatic HER2-positive NSCLC patients who have been previously treated with a non-HER2-directed systemic therapy. Bayer has set a wholesale price of $24,000 per month for twice-daily Hyrnuo and has also filed the drug in China.

Once-daily Hernexeos (zongertinib), meanwhile, was approved by the regulator in August for a similar indication, with a list price of $21,667 for a 60-count bottle, so, soon there will be two oral HER2 inhibitors available to patients with this type of non-squamous NSCLC in the US market.

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.

In tandem with the approval of Hyrnuo, the FDA also gave the go-ahead to a Life Technologies companion diagnostic that can be used to identify people with HER2 tyrosine kinase domain-activating mutations who may be eligible for treatment with the drug.

The accelerated approval for Bayer's drug was awarded on the strength of the SOHO-01 trial, which found an objective response rate (ORR) of 71% with sevabertinib and a median duration of response (DOR) of 9.2 months.

Hernexeos was cleared thanks to the Beamion LUNG-1 study, which revealed an ORR of 71% and a DOR of 14.1 months, although, as ever, there are pitfalls in trying to compare studies with different protocols and patient populations.

Both Bayer and Boehringer have aspirations to move their medicines into the first-line treatment setting in HER2-positive NSCLC, and at this year's ESMO congress reported data that made that case.

Boehringer presented new data from a first-line subpopulation of Beamion LUNG 01 cohort, revealing a 77% ORR, including 8% complete responses and 69% partial responses with Hernexeos, while Bayer reported that Hyrnuo achieved an ORR of 71% in a previously untreated arm of SOHO-1.

Both are also running phase 3 trials – respectively, Beamion LUNG 2 and SOHO-2 – that are specifically looking at frontline treatment of HER2-positive NSCLC.

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

Photo by National Cancer Institute on Unsplash