Novel Boehringer Drug for HER2-Mutant Lung Cancer Wins FDA Approval

 The FDA on Friday granted accelerated approval to zongertinib

opens in a new tab or window (Hernexeos) for non-squamous non-small cell lung cancer (NSCLC) patients harboring HER2 tyrosine kinase domain (TKD) activating mutations.

Approval of the tyrosine kinase inhibitor stipulates use in adults with unresectable or metastatic disease who have received prior systemic therapy and was based on results from the open-label, phase Ia/Ib Beamion LUNG-1 studyopens in a new tab or window.

Among 71 patients who received prior platinum-based chemotherapy but had not been previously treated with a HER2-targeted tyrosine kinase inhibitor or antibody-drug conjugate (ADC), the objective response rate (ORR) was 75%, with 58% having a duration of response of 6 months or longer.

Among 34 patients previously treated with platinum-based chemotherapy and a HER2-targeted ADC, the ORR was 44%, with 27% having a duration of response of 6 months or longer.

"With the approval of zongertinib, we have an effective, targeted, orally administered treatment option for patients with HER2-mutant non-small cell lung cancer in the U.S. that not only elicits a durable response but, importantly, has a manageable safety profile," said investigator John Heymach, MD, PhD, of the University of Texas MD Anderson Cancer Center in Houston, in a press releaseopens in a new tab or window from drugmaker Boehringer Ingelheim.

"In a patient population where there are currently limited treatment options, this approval represents a significant advancement in cancer care," he added.

Continued approval for the indication may be contingent upon results of a confirmatory trial.

The most common adverse reactions in the pooled safety population were diarrhea (53%), hepatotoxicity (27%), rash (27%), fatigue (22%), and nausea (21%). The discontinuation rate with zongertinib was 2.9%.

The prescribing information includes warnings and precautions for hepatotoxicity, left ventricular dysfunction, interstitial lung disease/pneumonitis, and embryo-fetal toxicity.

The Oncomine Dx Target Test was also approved as a companion diagnostic device to detect HER2 TKD activating mutations in patients with non-squamous NSCLC who may be eligible for treatment with zongertinib.

https://www.medpagetoday.com/hematologyoncology/lungcancer/116921