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Priority review status will allow for expedited development of zongertinib, putting it on the path toward approval as the first in a new class of drugs for mutated NSCLC.
The FDA has granted priority review status to the new drug application for zongertinib (BI 1810631; Boehringer Ingelheim), a Tyrosine kinase inhibitor (TKI) for the treatment of adult patients with unresectable or metastatic non-small cell lung cancer (NSCLC) whose tumors have HER2 (ERBB2) mutations and who have received prior systemic therapy, according to a news release from Boehringer Ingelheim.1
Non-small cell lung cancer can be difficult to treat and present with mutations. | Image Credit: © David A Litman - stock.adobe.com
Zongertinib was granted priority review status due to its potential to offer a significant improvement in treatment for patients with HER2-mutated NSCLC. The regulatory action was based in part on positive clinical trial results from the ongoing open-label, dose escalation, phase 1b Beamion LUNG-1 clinical trial (NCT04886804), which enrolled patients with NSCLC and some different types of tumors, though most patients across the population presented with a HER2 mutation.1,2
Results from cohort 1 (n = 75) of the trial demonstrated an objective response rate (ORR) of 71%. Six-month progression-free survival (PFS) and duration of response (DoR) in patients with mutations in the HER2 tyrosine kinase domain were 69% and 73%, respectively. Importantly, there was a safe adverse event (AE) profile with zongertinib, with patients experiencing a low incidence (5%) of dose reductions and treatment discontinuations (3%), according to the investigators. Furthermore, most of the treatment-emergent AEs observed were mild.1
Trial Name: Beamion LUNG-1: A Study to Test Different Doses of Zongertinib in People With Different Types of Advanced Cancer (Solid Tumours With Changes in the HER2 Gene)
ClinicalTrials.gov ID: NCT04886804
Sponsor: Boehringer Ingelheim
Estimated Completion Date: January 28, 2028
“We believe zongertinib has the potential to transform the care of previously treated patients with HER2 (ERBB2)-mutant advanced non-small cell lung cancer and are hopeful about the continued research in other tumor types and lines of therapy,” Shashank Deshpande, head of human pharma at Boehringer Ingelheim, said in the news release.1
Zongertinib is designed as an irreversible TKI. Its mechanism of action selectively inhibits HER2 while sparing EGFR, which leads to reduced associated toxicities. The drug is orally administered to patients and is being developed as a targeted treatment for patients with HER2-mutated, advanced NSCLC. Investigators plan to study zongertinib further compared with standard of care in Beamion LUNG-2, a phase 3 open-label, randomized, active-controlled clinical trial that is currently enrolling patients with unresectable or metastatic non-squamous NSCLC.1,3
The FDA previously granted breakthrough therapy designation and fast track designation to zongertinib. Its status as a TKI, a class of drugs that has generated major gains in treating difficult cancers, allows it to be modified or designed for selectivity; this makes zongertinib a seamless candidate for NSCLC treatment since the cancer comprises myriad oncogenic alternations. Zongertinib has clear potential to become the first in a new generation of TKIs that can treat patients with metastatic, advanced, or unresectable disease with HER2 mutations, building on the strength of TKIs overall.3
“Personalized medicine has revolutionized cancer treatment,” Courtney Granville, chief scientific officer of GO2 for Lung Cancer, said in the news release. “Early screening and biomarker testing for mutations provide critical information to guide targeted therapies in personalized medicine.”1
“This filing acceptance represents a significant step toward offering another option for individuals with a HER2 (ERBB2) diagnosis, bringing hope and direction to cancer patients,” Granville concluded.1
