EGFR mutation

It received its first approval under accelerated approval in August 2025 in the USA following positive results from the Beamion LUNG-1 phase Ia/Ib trial in patients with previously treated HER2-mutant non-small cell lung cancer (NSCLC). This article summarizes the milestones in the development of zongertinib leading to this first approval for the treatment of adult patients with unresectable or metastatic NSCLC whose tumours have HER2 tyrosine kinase domain activating mutations, as detected by an FDA-approved test, and who have received prior systemic therapy.

After resolution with corticosteroids, treatment was switched to afatinib. This study highlights the heterogeneous approaches to OILI and the potential feasibility of rechallenge in selected patients. Given the expanding osimertinib use for early and advanced stage NSCLC, further research is warranted to refine treatment decisions and optimize patient safety.

The combination of IT via Ommaya reservoir and WBRT may result in better survival in EGFR-mutant NSCLC patients with LM and represents a promising treatment strategy for this patient population.

Preoperative ctDNA detection and pathological venous invasion provide complementary prognostic information, and venous invasion is an independent predictor of recurrence risk in EGFR-mutated NSCLC. Combined assessment may refine postoperative risk stratification and inform perioperative management.

This tendency was not changed by everolimus (HR = 2.66), but was abrogated slightly by sunitinib (HR = 1.59) and considerably by ICI-based therapies, including nivolumab monotherapy (HR = 1.12), atezolizumab plus bevacizumab (HR = 1.10), and avelumab plus axitinib (HR = 0.69). Overall, our findings suggest that NF1/2 mutations can serve as predictive biomarkers for favorable benefits from ICI-based treatments over VEGFR/mTOR inhibitors in advanced ccRCCs.

The savolitinib-osimertinib combination improved PFS versus chemotherapy in patients with EGFR mutation-positive, MET-amplified NSCLC that had progressed on EGFR TKI therapy, while maintaining a favourable tolerability profile. This regimen offers a potential oral treatment option for this biomarker-selected population.

PRO results indicate that the clinical benefits of adding amivantamab to chemotherapy were achieved without compromising health-related QoL. Amivantamab-chemotherapy prolonged TTSP versus chemotherapy alone.

P1, N=105, Active, not recruiting, Novartis Pharmaceuticals | Trial completion date: Mar 2026 --> Oct 2026 | Trial primary completion date: Mar 2026 --> Oct 2026

P=N/A, N=42, Not yet recruiting, Guangzhou University of Traditional Chinese Medicine

P3, N=545, Active, not recruiting, Eli Lilly and Company | Trial completion date: Dec 2025 --> Dec 2026

Most GPs were not familiar with liquid biopsy but 72 % supported these tests to be incorporated into current pathways. Liquid biopsy could potentially reduce diagnostic delays and inequities in lung cancer.