In an accelerated decision, the FDA expanded Bayer’s Hyrnuo indication, granting first-line approval for a rare tumor type in patients with non-small cell lung cancer.
Before the expansion, Hyrnuo was available only after other NSCLC treatments failed. But the FDA’s latest go-ahead makes the tyrosine kinase inhibitor (TKI) an initial therapy option for any patient with locally advanced or metastatic non-squamous NSCLC whose tumors test positive for HER2 tyrosine kinase domain activating mutations.
The expanded indication was won using data from Bayer’s ongoing phase 1/2 Soho-01 trial, in which Hyrnuo demonstrated a 75% objective response rate in previously untreated patients. Six percent of patients showed a complete response, and 70% showed a partial response to the twice-daily oral medication, Bayer said Wednesday. Responses lasted more than six months for 73% of patients.
This subtype of lung cancer patients are often non-smokers and “historically have a poor prognosis,” said Soho-01 lead investigator, Xiuning Le, M.D., Ph.D., of The University of Texas MD Anderson Cancer Center, in a statement.
“This approval underscores the potential of precision medicine to transform outcomes by matching the right patients to the right therapy at the right time,” added Christine Roth, executive vice president, global product strategy and commercialization at Bayer.
The accelerated approval means Bayer will have to continue to prove Hyrnuo’s clinical benefit through post-marketing confirmatory studies. The latest approval may hinge on the outcome of Bayer's phase 3 trial, Soho-02, which is evaluating Hyrnuo versus standard of care in treatment-naïve patients with advanced HER2-mutant NSCLC.
The Hyrnuo expansion follows a similar first-line approval for the drug's main competitor, Boehringer Ingelheim’s oral TKI Hernexeos, in February. Because HER2 mutations represent only 2% to 4% of the NSCLC patient population, the battle for market share between the two drugs is expected to be fierce.
Both Bayer and Boehringer's target the same mutated tumors, although Hyrnuo is specifically designated for locally advanced or metastatic non-squamous NSCLC, while Boehringer’s label holds a small distinction for unresectable or metastatic cancer.
Hyrnuo received initial FDA approval last November, just three months after Hernexeos. In that instance, the FDA signed off on the medicine as a second-line treatment after Hyrnuo logged a 71% objective response rate in the phase 1/2 Soho-01 trial in patients who received prior systemic therapy but not one that specifically targets HER2 mutations.
Earlier this year, Hyrnuo was approved in China as a second-line treatment for unresectable, locally advanced or metastatic HER2-mutant NSCLC. The drug was also granted breakthrough therapy designation in the country to expedite its potential use as a first-line treatment, and it has also secured a first-line nod in Japan.