HLB's 'Lenvatinib' Shows Excellent Clinical Results in Cervical Cancer, Lung Cancer, and Sarcoma at ASCO... "Complete Remission Cases Also Observed"

[Asia Economy Reporter Hyunseok Yoo] HL Biopharma announced on the 14th that a total of 16 clinical presentations on Rivoceranib will be made at the American Society of Clinical Oncology (ASCO), held from the 29th to the 31st. According to the company, among these, there are numerous meaningful results, including complete remission observed in cervical cancer from clinical data by Chinese researchers.

First, the results of a Phase 2 clinical trial of the combination therapy of Rivoceranib and Camrelizumab in patients with advanced cervical cancer who failed first-line chemotherapy were presented. Among 45 patients, the objective response rate (ORR) was 59.6%, including 2 cases of complete remission, and the disease control rate (DCR) was 88.1%, demonstrating excellent efficacy. Cases of complete remission with Rivoceranib have also been reported in the global Phase 3 monotherapy trial for gastric cancer, and continue to be reported in various cancer types such as brain tumors, hematologic cancers, colorectal cancer, and hepatocellular carcinoma.

Notably, the ORR was 50% not only in PD-L1 positive patients but also in PD-L1 negative patients. This outstanding efficacy in patients with low response rates to immune checkpoint inhibitors proves that Rivoceranib is the optimal partner for immune checkpoint inhibitors.

Clinical results for non-small cell lung cancer (NSCLC) are also noteworthy. A Phase 2 clinical trial of the combination therapy of Rivoceranib and Camrelizumab as first-line treatment for squamous cell carcinoma, a subtype of NSCLC, was presented. Although the number of patients was small at 17, the ORR was 76.5% and the DCR was 100%, showing excellent figures.

NSCLC is divided into adenocarcinoma, squamous cell carcinoma, and large cell carcinoma, with squamous cell carcinoma accounting for about 29% of all lung cancers. At this ASCO, clinical trial results for extensive-stage small cell lung cancer (SCLC) were also presented. SCLC accounts for 15% of lung cancer patients, and the expected survival for extensive-stage SCLC with metastasis is relatively low at about 2 to 4 months. While the previous AACR presentation was on second-line treatment patients, the ASCO presentation showed very meaningful results with a 6-month ORR of 63% and a DCR of 85% when combined with cytotoxic chemotherapy as first-line treatment.

Phase 2 clinical trial results for soft tissue sarcoma patients who failed first-line chemotherapy also showed very meaningful outcomes with an ORR of 18.75% and a DCR of 87.5%.

Other clinical trial results presented include combination therapy with TACE in hepatocellular carcinoma, combination with docetaxel in NSCLC with bone metastasis, combination with temozolomide in melanoma patients who failed PD-1 therapy, and Rivoceranib monotherapy in cholangiocarcinoma patients who failed standard treatment.

HL Biopharma, which has observed excellent disease control rates through Rivoceranib clinical trials, acquired global rights including China from Adventzen Research Institute and will start receiving royalties from this year based on last year's sales. Rivoceranib alone generated approximately KRW 370 billion (2.1 billion CNY) in sales last year in China for gastric cancer treatment, and royalty income is expected to increase further upon approval for hepatocellular carcinoma.