HLB "Lenvatinib Approved for Phase 3 Clinical Trial as First-Line Treatment for Lung Cancer in China"

[Asia Economy Reporter Hyunseok Yoo] HL Biopharma announced on the 16th that China’s Hansoh Pharmaceutical has received approval for a Phase 3 clinical trial of a combination therapy using rivoceranib (Chinese name Apatinib, brand name Ai Tan) targeting first-line treatment for lung cancer.

Last month, Hansoh Pharmaceutical received approval for a Phase 3 clinical trial combining rivoceranib and Iressa (Gefitinib) targeting first-line treatment for non-small cell lung cancer (NSCLC). This time, approval was granted for a Phase 3 trial combining rivoceranib with camrelizumab (PD-1 inhibitor) as a first-line treatment for NSCLC.

In other words, rivoceranib is included in both Phase 3 clinical trials for first-line lung cancer treatment.

Currently, first-line treatment for NSCLC varies depending on markers such as EGFR (epidermal growth factor receptor), ALK (anaplastic lymphoma kinase), ROS1 (oncogene activated in lung cancer), and PD-L1 (a protein that prevents immune cells from being activated by cancer cells). According to the company, Hansoh Pharmaceutical is advancing Phase 3 clinical trials applying rivoceranib to patients positive for EGFR and PD-L1, respectively.

Clinical trial results of rivoceranib for NSCLC in China have been announced several times. According to a paper published last year in Scientific Reports, rivoceranib showed a disease control rate (DCR) of 76.9% and an objective response rate (ORR) of 28.2% in patients resistant to EGFR, which was significantly better compared to the control group’s DCR of 20.7% and ORR of 3.4%.

Also, at last year’s American Society of Clinical Oncology (ASCO) meeting, investigator clinical results of the combination of rivoceranib and camrelizumab were presented. This study targeted wild-type EGFR and ALK NSCLC patients, showing a DCR of 85.7% and ORR of 33.3% in patients who had received two or more prior treatments, and a DCR of 80% and ORR of 28.6% in first-line patients, demonstrating very meaningful results.

An HL Biopharma official stated, “Hansoh Pharmaceutical appears to be advancing commercialization Phase 3 trials for NSCLC based on multiple excellent clinical trial results,” adding, “This once again confirmed the strength of rivoceranib as an optimized drug for combination therapy.”

Last month, HL Biopharma signed a contract to acquire global rights, including China, for rivoceranib from Adventzen. Recently, Hansoh Pharmaceutical applied for marketing approval of rivoceranib as a second-line treatment for liver cancer in China, and various attempts are being made to expand indications such as lung cancer Phase 3 trials. Expectations for increased royalty revenue for HL Biopharma are also growing.

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