HLB "Lenvatinib Achieves 'Complete Remission' in EGFR-Mutant Lung Cancer Patients... Successful Completion of Phase 3 Clinical Trial"

[Asia Economy Reporter Hyunseok Yoo] HL Biopharma announced on the 8th that Hansoh Pharmaceutical revealed on its website on the 6th that the Phase 3 clinical trial results of the first-line treatment for non-small cell lung cancer (NSCLC) orally administered with a combination of Rivoceranib and Gefitinib were successfully completed. The results of this Phase 3 clinical study were published in the globally renowned medical journal, the Journal of Thoracic Oncology.

Led by the faculty of Zhongshan University Cancer Center, the Phase 3 clinical trial (clinical trial name ‘ACTIVE’) combining Rivoceranib (VEGFR inhibitor) and Gefitinib (EGFR inhibitor) was conducted at more than 30 hospitals across China. The study enrolled 313 patients who had not previously received chemotherapy or targeted therapy and randomly assigned them in a double-blind manner to receive either the combination of Rivoceranib and Gefitinib or a placebo plus Gefitinib. This clinical trial attracted significant attention from the early stages as it involved a combination of oral targeted anticancer drugs: Rivoceranib, which inhibits tumor angiogenesis, and Gefitinib, which inhibits epithelial cell growth.

The clinical results showed a complete response in one patient, and the primary endpoint, median progression-free survival (mPFS), was 13.7 months, significantly improving compared to 10.2 months in the control group, demonstrating excellent therapeutic efficacy by markedly extending patients' progression-free survival.

Existing NSCLC treatments, including Gefitinib, have shown good therapeutic effects in patients with confirmed epidermal growth factor receptor (EGFR) gene mutations, but drug resistance has long been an issue. In particular, for first-generation drugs like Gefitinib, resistance was observed in 50% of patients within 10 months of administration and in 90% of patients after 2 years. Medical professionals are currently considering using third-generation anticancer drugs as first-line treatments or combining new therapies after first-line treatment to delay drug resistance. However, when resistance to third-generation anticancer drugs occurs, there is no established standard treatment, and multiple subsequent treatments impose significant economic and physical burdens, leaving no suitable alternatives yet.

In this context, the recent clinical results confirmed that the combination of oral anticancer drugs Rivoceranib and Gefitinib not only provides high therapeutic efficacy but also improves patient convenience and adherence, suggesting a new treatment alternative. Professor Gu Kangsheng of the First Affiliated Hospital of Anhui Medical University also expressed expectations, stating, “The results of the ‘ACTIVE’ clinical trial are significant as they confirm that the combination therapy of Rivoceranib and Gefitinib could become an important alternative as a first-line treatment for non-small cell lung cancer.”

Rivoceranib has so far been reported to achieve complete remission cases in monotherapy and combination therapy for lung cancer, gastric cancer, esophageal cancer, lymphoma, and others. HL Biopharma, a KOSDAQ-listed company, holds the global rights to Rivoceranib and is currently preparing a new drug application after completing a clinical trial for advanced gastric cancer. Additionally, global clinical trials are underway for first-line treatment of salivary gland carcinoma, second-line gastric cancer, and third-line colorectal cancer. The two companies maintain a continuous partnership, including conducting a global Phase 3 clinical trial combining Hansoh Pharmaceutical’s Camrelizumab (PD-1 inhibitor) with first-line treatment for liver cancer.

This content was produced with the assistance of AI translation services.