Bayer’s Lung Cancer Drug Hyrnuo Wins FDA Approval as a First-Line Treatment, Competing With Hernexeos

Bayer’s targeted cancer drug Hyrnuo has been approved by the U.S. Food and Drug Administration (FDA) as a first-line treatment for non-small cell lung cancer.

According to Fierce Pharma on the 10th (local time), the FDA expanded Hyrnuo’s indication through the accelerated approval pathway. The decision makes Hyrnuo an initial treatment option for patients with locally advanced or metastatic nonsquamous non-small cell lung cancer with confirmed activating HER2 tyrosine kinase domain mutations.

Previously, Hyrnuo could be given only to patients whose non-small cell lung cancer had not responded to other treatments. Hyrnuo belongs to the tyrosine kinase inhibitor (TKI) class.

The indication expansion was based on data from Bayer’s ongoing phase 1/2 clinical trial, SOHO-01. In the trial of treatment-naive patients, Hyrnuo had an objective response rate of 75%. Bayer said on the 9th that 6% of patients had a complete response and 70% had a partial response to the oral drug, which is taken twice daily. Responses lasted at least 6 months in 73% of patients.

SOHO-01 principal investigator Siu Ning Leu, MD, of The University of Texas MD Anderson Cancer Center, said patients with this type of lung cancer are often nonsmokers and “historically have had a poor prognosis.”

Christine Roth, Bayer’s vice president of global product strategy and commercialization, said, “This approval demonstrates the potential of precision medicine to change outcomes by connecting the right patients with the right treatment at the right time.”

Because the approval is accelerated, Bayer must continue to demonstrate Hyrnuo’s clinical benefit in a postmarketing confirmatory trial. The approval could depend on results from SOHO-02, a phase 3 clinical trial comparing Hyrnuo with standard treatment in treatment-naive patients with advanced HER2-mutant non-small cell lung cancer.

Hyrnuo’s expanded indication follows the approval in February of competing drug Hernexeos, an oral TKI from Boehringer Ingelheim, as a first-line treatment. HER2 mutations account for only 2~4% of non-small cell lung cancer cases, so the two drugs are expected to compete intensely for market share.

Both drugs target tumors with the same mutation, but their indications differ. Hyrnuo is indicated for locally advanced or metastatic nonsquamous non-small cell lung cancer, while Hernexeos is indicated for unresectable or metastatic cancer.

Hyrnuo received its first FDA approval last November, 3 months after Hernexeos. At the time, it was approved as a second-line treatment based on an objective response rate of 71% in the phase 1/2 SOHO-01 trial.

Earlier this year, Hyrnuo was approved in China as a second-line treatment for unresectable, locally advanced or metastatic HER2-mutant non-small cell lung cancer. It also received breakthrough therapy designation in China to accelerate its use as a first-line treatment and secured first-line approval in Japan.