2024 World Conference on Lung Cancer (WCLC) - ePosters-EP.12H.08 SOHO-02: Phase III Trial of BAY 2927088 In Patients with Locally Advanced or Metastatic NSCLC with HER2-Activating Mutations

EP.12H.08 SOHO-02: Phase III Trial of BAY 2927088 In Patients with Locally Advanced or Metastatic NSCLC with HER2-Activating Mutations

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The document outlines the Phase III SOHO-02 trial, which investigates BAY 2927088—a novel oral tyrosine kinase inhibitor (TKI)—in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) possessing HER2-activating mutations. HER2 mutations in NSCLC, prevalent in 2-4% of cases, are largely exon 20 insertions, often associated with Asian ethnicity and non-smoking status. Previous treatments like platinum-based chemotherapy have shown unsatisfactory outcomes for these mutations, highlighting the need for effective targeted therapies.<br /><br />BAY 2927088 has demonstrated promising anti-tumor activity and a favorable safety profile in earlier Phase I/II trials, specifically in patients with HER2-mutant NSCLC. In the ongoing Phase III trial (NCT06452277), the study design involves a randomized, open-label, and active-controlled approach to evaluate its efficacy. Key trial endpoints include progression-free survival (PFS), overall survival, and overall response rate (ORR). The recruitment aims to enroll 278 patients across 36 countries, ensuring diverse and comprehensive data.<br /><br />Patients eligible for inclusion must have documented locally advanced or metastatic NSCLC with specific HER2 tyrosine kinase domain mutations. They shouldn't have received systemic therapy for their advanced or metastatic condition and must be eligible for platinum-doublet chemotherapy and pembrolizumab treatment. The standard care comparator arm includes combinations of cisplatin or carboplatin with pemetrexed and pembrolizumab.<br /><br />The study underscores Bayer AG's commitment as the sponsor, providing hope for more effective intervention in HER2-mutant NSCLC, a challenging cancer subset lacking efficient targeted treatments up till now. This initiative represents a significant step towards advancing NSCLC therapies tailored to genetic profiles, improving outcomes for patients affected by HER2-activating mutations.

Asset Subtitle

Koichi Goto

Meta Tag

Speaker Koichi Goto

Topic Metastatic Non-small Cell Lung Cancer – Targeted Therapy

Keywords

Phase III SOHO-02 trial

BAY 2927088

tyrosine kinase inhibitor

non-small cell lung cancer

HER2-activating mutations

HER2-mutant NSCLC

progression-free survival

overall response rate

platinum-based chemotherapy

Bayer AG