Osimertinib mesylate

Dizal (SSE:688192) reported new clinical data for sunvozertinib NSCLC at the 2026 European Lung Cancer Congress in Copenhagen, showing an 81.3% objective response rate when the oral EGFR inhibitor, marketed as Zegfrovy, was used as first-line monotherapy in patients with advanced non-small cell lung cancer harboring EGFR P-loop and αC-helix compressing mutations or other uncommon EGFR variants. The data, drawn from a single-arm cohort dosed at the recommended Phase III level of 300 mg daily, position the drug as a potential oral alternative in a molecular subgroup where platinum-doublet chemotherapy has remained the default option. The data come from a single-arm cohort treated at the recommended Phase III dose of 300 mg daily and highlight a potential oral option in a molecular subgroup where targeted therapies have shown inconsistent activity and chemotherapy has often remained the default. Trial specifics PACC mutations account for roughly 12.5% of EGFR mutations in NSCLC and are less responsive to standard EGFR inhibitors such as osimertinib. While afatinib is approved for select uncommon mutations (S768I, L861Q, G719X), no targeted therapy specifically addresses the broader PACC category. Among evaluable patients, tumor shrinkage was observed in 100%, with an ORR of 81.3% and a disease control rate of 100%. Activity extended to the central nervous system: among 15 patients with untreated brain metastases, 11 responded, including six confirmed partial responses. Median duration of response was not reached, with an estimated 6-month durable response rate of 87.5%. Progression-free survival data were immature, with an estimated 9-month PFS rate of 83.9%. Approximately 81.3% of patients remained on treatment at data cutoff. The safety profile was consistent with prior studies, with mostly grade 1–2 treatment-emergent adverse events. The dataset remains early and should be interpreted cautiously. The cohort size was not disclosed in the release, and the findings are based on a single-arm, investigator-assessed analysis. Expanding beyond exon 20 insertions Zegfrovy is approved in the US and China for EGFR exon 20 insertion NSCLC following progression on platinum-based chemotherapy. Dizal recently reported that the Phase III WU-KONG28 trial met its primary endpoint in first-line exon 20 insertion disease. The ELCC data extend sunvozertinib’s activity into uncommon EGFR mutations, including PACC, in the first-line setting. In exon 20 insertions, sunvozertinib competes with amivantamab, an antibody therapy requiring clinic-based administration. Sunvozertinib’s once-daily oral dosing offers a practical advantage, though no head-to-head comparisons are available. For uncommon EGFR mutations, however, treatment options remain limited. If confirmed in larger studies, the high response rate observed here could support expansion into this underserved population. Near-term catalysts include full Phase III data from WU-KONG28, which may support first-line approval in exon 20 insertion NSCLC. For PACC and other uncommon mutations, further development will likely require larger, controlled studies. Leave a Reply Cancel reply Your email address will not be published. Required fields are marked * Comment * Name * Email * Website

- Dalmelitinib (HS-10241) has demonstrated encouraging anti-tumor activity and a manageable safety profile when combined with Aumotinib in MET-amplified NSCLC patients post EGFR TKI. SHANGHAI, March 27, 2026, Hansoh Pharmaceutical Group Co., Ltd. (“Hansoh Pharma,” 03692.HK) today announced the study data of Dalmelitinib Mesylate Tablets (HS-10241, Dalmelitinib in short) combined with Aumolertinib Mesylate Tablets (Aumoloertinib in short), for the treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) with MET amplification post EGFR TKI treatment, were presented in a poster session at the European Lung Cancer Congress (ELCC) 2026 (March 25-28, Copenhagen). Dalmelitinib is an oral, highly selective MET-TKI under clinical development for NSCLC patients. At ELCC 2026, the presented data was generated from HS-10241-102 (NCT05430386), which aimed to evaluate the safety, efficacy and pharmacokinetic (PK) profile of the combination of HS-10241 with Aumolertinib. Study results showed: ● Encouraging Efficacy：In 115 efficacy-evaluable NSCLC patients with MET-amplification post EGFR TKI treatment, median PFS was 7.4 months and median OS was 25.4 months. ● Manageable safety profile: Overall, the combination of Dalmelitinib with Aumolertinib in 132 patients showed a manageable safety profile. Most TEAEs were grade 1-2, and were generally reversible. ● Conclusions: The combination of Dalmelitinib and Aumolertinib demonstrated encouraging clinical activity in NSCLC with MET amplification post EGFR TKI, where >85% of efficacy evaluable patients had received prior third-generation EGFR-TKI therapy which represented current clinical practice. Notably, this study enrolled patients with a broader MET-amplification threshold (MET gene copy number ≥5 or MET/CEP7 ratio ≥2, regardless any type of prior EGFR TKI) compared to previously reported studies. The safety profile was manageable with reversible AEs, and no new safety signals were identified. A randomized phase 3 study evaluating this combination is currently ongoing; results are anticipated. Details of the poster presentation are as follows: ◆ Poster Title: Dalmelitinib (HS-10241) combined with Aumolertinib in EGFR-TKIs-pretreated patients with EGFR- mutant and MET-amplified advanced NSCLC: a phase 1b study ◆ Session: Advanced NSCLC ◆ Abstract No.: FPN.31P ◆ Date/Time: Friday, 27 March 13:00-14:00 (CET) ◆ Presenting author: Prof. Xiaorong Dong/ Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China ◆ Corresponding author: Prof. Shun Lu/ Shanghai Chest Hospital, Jiaotong University, Shanghai, China About Dalmelitinib (HS-10241) Dalmelitinib Mesylate Tablets (HS-10241) is an innovative drug independently developed by the Group with proprietary intellectual property rights. As a small-molecule, highly selective MET receptor tyrosine kinase inhibitor, it can binds to the catalytic domain of the c-MET kinase, inhibiting its activity, thereby inhibiting cellular transformation or cancer cell proliferation. Previously, the New Drug Application (NDA) for Dalmelitinib was accepted by the National Medical Products Administration (NMPA) of China, for the treatment of locally advanced or metastatic NSCLC adult patients with MET amplification post EGFR TKI. About NSCLC EGFR TKI had been widely used as first line treatment of EGFR-mutant advanced non-small cell lung cancer (NSCLC). After treatment with EGFR TKIs, most patients develop acquired resistance (AR) [1] , leading to disease progression, the mechanism of resistance is complicated especially post third generation TKI. c-MET amplification is one of the important mechanisms of AR. Among cases of secondary resistance to EGFR TKIs, the proportion with c-MET amplification is approximately 5% to 22%[2-4] . Studies have also found that in a very small subset of patients, c-MET amplification is detected before the use of EGFR TKIs. Even in the presence of EGFR-sensitive mutations, the therapeutic efficacy of EGFR TKIs is suboptimal, indicating the existence of primary resistance[5-6]. References 1.Mok TS, Wu Y-L, Ahn M-J, et al; AURA3 Investigators. Osimertinib or Platinum-Pemetrexed in EGFR T790M-Positive Lung Cancer. N Engl J Med. 2017 Feb 16;376(7):629-640. 2.Tartarone A, Lerose R. Clinical approaches to treat patients with non-small cell lung cancer and epidermal growth factor receptor tyrosine kinase inhibitor acquired resistance. Ther Adv Respir Dis. 2015;9(5):242–50. 3.Juchum M, Gunther M, Laufer SA. Fighting cancer drug resistance: opportunities and challenges for mutation-specific EGFR inhibitors. Drug Resist Updat. 2015;20:10–28. 4.Remon J, Moran T, Majem M, et al. Acquired resistance to epidermal growth factor receptor tyrosine kinase inhibitors in EGFR-mutant non-small cell lung cancer: a new era begins. Cancer Treat Rev. 2014;40:93–101. 5.Benedettini E, Sholl LM, Peyton M, et al, Yeap BY, Fiorentino M, et al. Met activation in non-small cell lung cancer is associated with de novo resistance to EGFR inhibitors and the development of brain metastasis. Am J Pathol. 2010;177(1):415. 6.Turke AB, Zejnullahu K, Wu YL, et al. Preexistence and clonal selection of MET amplification in EGFR mutant NSCLC. Cancer Cell. 2010;17(1):77. About Hansoh Pharma Hansoh Pharma is a leading innovation-driven pharmaceutical enterprise headquartered in China. With the mission of "continuous innovation for better life", the company focuses on major disease therapeutic areas such as oncology, anti-infectives, central nervous system (CNS), metabolism and immunology. Hansoh Pharma has launched 7 innovative drugs that generate product sales in China, with the revenue from innovative drugs and collaborative products exceeding 80%, forming a rich product pipeline. The company has consistently ranked among the top 100 global pharmaceutical companies and is recognized as one of the top 3 pharmaceutical R&D enterprises in China and is designated as a National Key High-Tech Enterprise and a National Technology Innovation Demonstration Enterprise. Hansoh Pharma was listed on the Hong Kong Stock Exchange in June 2019 (stock code: 03692.HK). Statements 1. This announcement is intended for healthcare professionals only and not for advertising purposes.2. Hansoh Pharma does not recommend the use of any unapproved drugs or off-label indications, nor does it make recommendations regarding any drug or indication.3. The information provided in this announcement is for reference only; please follow the advice or guidance of a physician or other healthcare professional. Any treatment-related decisions made by healthcare professionals should be based on the specific circumstances of the patient and should be used in accordance with the instructions for the drug.4. For more detailed information about any company products, medical treatments, or diseases, please consult a healthcare professional. Forward-Looking Statements This press release is intended to provide information about Hansoh Pharmaceutical Group Co., Ltd. and its affiliates, including their subsidiaries (collectively referred to as "Hansoh Pharma"). 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