New hope for lung cancer patients

CHICAGO/BEIJING, May 11, 2025 – A novel oral medication has demonstrated remarkable success in treating a challenging form of lung cancer, according to landmark research published in The New England Journal of Medicine (NEJM) and presented at the American Association for Cancer Research (AACR) Annual Meeting.

Targeting HER2-Mutant NSCLC: A New Hope

The international study, co-led by Chinese and US researchers, reveals that zongertinib – developed by Boehringer Ingelheim and Sino Biopharmaceutical – outperforms current standard treatments for HER2-mutated non-small cell lung cancer (NSCLC).

Key Advantages of Zongertinib:
71% tumor response rate (vs. 49% with ADC therapy)
12.4 months progression-free survival (vs. 9.9 months)
Dramatically reduced severe side effects (1% diarrhea cases vs. 17-26%)

“This could redefine first-line treatment for HER2-mutant NSCLC,” said Prof. Wang Xin of the Chinese Academy of Medical Sciences Cancer Hospital.

Global Trial with Asian Leadership
The phase 1/2 trial spanned 82 sites worldwide, with 188 patients (majority Asian). Key findings:
– Tumor shrinkage in 71% of zongertinib patients
– Fewer adverse events compared to intravenous antibody-drug conjugate (ADC) therapy
– Oral administration offers convenience over infusion-based treatments

Currently, only one FDA-approved ADC therapy exists for this cancer subtype, often causing significant side effects like fatigue, nausea, and rashes.

Phase 3 Trials Underway

With 169 hospitals now enrolled across the US, China, and Japan, the ongoing phase 3 trial aims to confirm zongertinib’s efficacy as a first-line treatment.

China’s Growing Role in Clinical Research

The trial highlights China’s emergence as a cost-effective hub for drug development:
– $41,000 per patient vs. $500,000 in the US
– 25 Chinese sites participating in phase 3

“China delivers high-quality trials at one-tenth the cost of Western countries – that’s our competitive edge,” noted **Dr. Li Jin of Shanghai’s Tongji University.

Why This Matters

Lung cancer remains the world’s deadliest malignancy, with 2.5 million new cases and 1.8 million deaths annually. HER2 mutations affect 2-4% of NSCLC patients, representing a critical unmet need.

The Bottom Line:
Zongertinib could soon become the new gold standard for HER2-mutant NSCLC, offering better outcomes, fewer side effects, and greater accessibility – a win for patients and the pharmaceutical industry alike.

Source : scmp.com

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