Afatinib Dimaleate

Dizal (SSE:688192) reported that its Phase III WU-KONG28 trial of sunvozertinib (Zegfrovy) met its primary endpoint in first-line NSCLC harboring EGFR exon 20 insertion mutations, with the oral EGFR inhibitor delivering a statistically significant improvement in progression-free survival over platinum-based chemotherapy. The result positions sunvozertinib as the first targeted oral, chemo-free monotherapy regimen to generate Phase III data showing PFS benefit against chemotherapy in this mutation-defined population. WU-KONG28 is a multinational, open-label, randomized Phase III trial conducted across 16 countries comparing once-daily oral sunvozertinib monotherapy to investigator-choice platinum-containing doublet chemotherapy in treatment-naive patients with advanced NSCLC driven by EGFR exon 20 insertion mutations. PFS, assessed by blinded independent central review, served as the primary endpoint. Dizal disclosed that sunvozertinib achieved a statistically significant and clinically meaningful PFS advantage over chemotherapy. The company also stated that all prespecified secondary endpoints, including confirmed objective response rate, duration of response, and disease control rate, favored the sunvozertinib arm. Specific numerical results for PFS and secondary endpoints were not disclosed – the company said detailed data will be submitted for presentation at an upcoming scientific congress. Sunvozertinib was generally well tolerated, with a safety profile consistent with earlier studies. The most common treatment-emergent adverse events were Grade 1 or 2 in severity, according to the company. Sunvozertinib is an irreversible, oral small-molecule EGFR tyrosine kinase inhibitor designed to selectively target mutant EGFR while sparing wild-type receptor activity. EGFR exon 20 insertion mutations represent approximately 1-2% of all NSCLC cases and have historically been resistant to first- and second-generation EGFR inhibitors such as erlotinib and afatinib. The structural heterogeneity of these insertions, with over 100 identified subtypes, has made drug design against this target class particularly difficult, and patients have until now relied on platinum-based chemotherapy as first-line treatment. Sunvozertinib already holds approvals in both the United States and China for adult patients with locally advanced or metastatic NSCLC with EGFR exon 20 insertion mutations whose disease has progressed on or after platinum-based chemotherapy. The US approval was supported by the multinational WU-KONG1 Part B study, while the China approval drew on the WU-KONG6 trial. Johnson & Johnson’s amivantamab (Rybrevant), a bispecific antibody targeting EGFR and MET, and Takeda’s mobocertinib were both approved in the second-line exon 20 insertion setting, though Takeda voluntarily withdrew mobocertinib from the US market in 2023 after a confirmatory trial failed to meet its primary endpoint. Amivantamab in combination with chemotherapy has been studied in earlier lines of therapy for broader EGFR-mutant populations, but no targeted oral agent had previously demonstrated a Phase III PFS benefit as monotherapy versus chemotherapy in the first-line exon 20 insertion setting specifically. Cross-trial comparisons are limited by differences in study design, patient populations, and endpoints. The WU-KONG28 result is therefore notable for establishing, in a controlled setting, that a chemotherapy-free oral regimen can outperform the existing standard of care for a patient population with limited targeted treatment options. Sunvozertinib has received Breakthrough Therapy Designation from both the US FDA and China’s Center for Drug Evaluation for the first-line exon 20 insertion indication, which may facilitate regulatory review timelines. Dizal said it plans to engage with regulatory authorities regarding potential new drug applications based on the WU-KONG28 data. Your email address will not be published. Required fields are marked * Comment * Name * Email * Website

Adalvo has received marketing authorisation via the DCP for its generic Afatinib film-coated tablets in Europe. The approval covers all strengths: 20, 30, 40 and 50 mg. Afatinib is indicated for the first-line treatment of adult patients with advanced non-small cell lung cancer (NSCLC) harbouring activating EGFR mutations and belongs to the established class of EGFR tyrosine kinase inhibitors. Afatinib works by irreversibly blocking the ErbB family of proteins involved in tumour growth and progression in EGFR-mutated NSCLC. Unlike first-generation EGFR inhibitors, it binds covalently, resulting in prolonged inhibition of ErbB signalling. NSCLC accounts for approximately 85% of all lung cancer cases globally. EGFR mutations occur in around 10–35% of NSCLC adenocarcinomas, with higher prevalence observed in Asian populations. According to IQVIA, MAT sales for Afatinib reached $229M in Q4 2025. With marketing authorisations now in place across EU markets, Adalvo can offer partners licensing opportunities to bring this approved generic to patients. The successful development of Afatinib further strengthens Adalvo’s oncology portfolio and demonstrates its capabilities in developing and delivering complex solid oral oncology therapies. To discuss partnership opportunities or to explore Adalvo's full oncology pipeline, contact us today.