While a total of 16 clinical presentations are expected at the American Society of Clinical Oncology (ASCO), occurring May 29-31, Rivoceranib reported very meaningful results, including complete remission in cervical cancer. In addition, the phase 3 trial results of hepatocellular carcinoma were announced and raised a possibility of approval in China.
First, phase 2 trials results of combination therapy with Rivoceranib and Camrelizumab were presented in patients with progressive cervical cancer who failed in 1st line anti-cancer treatment. The results from 45 patients were excellent with the Overall Response Rate (ORR) of 59.6% and the Disease Control Rate (DCR) of 88.1% (including 2 complete remissions). Rivoceranib's complete remission case has also been reported in the global phase 3 of gastric cancer monotherapy and has been reported in a variety of cases including brain tumors, blood cancer, colorectal cancer, and hepatocellular carcinoma.
In particular, the ORR was 50% in PD-L1 positive patients as well as in negative patients, and it showed an excellent effect in patients with a low response rate of immune checkpoint inhibitors, which proved that Rivoceranib is the optimal partner.
The clinical results for Non-Small Cell Lung Cancer (NSCLC) are also noteworthy. As a 1st line treatment of Squamos Cell Lung Cancer (SQCLC), combination therapy of Rivoceranib and Camrelizumab presented phase 2 trial results. Although the number of patients was small with 17 patients, the results were excellent with ORR of 76.5% and DCR of 100%.
NSCLC is divided into adenocarcinoma, SQCLC, and large cell carcinoma. SQCLC accounts for about 29% of all lung cancers. Following the American Association for Cancer Research (AACR), clinical trial results for diastolic Small Cell Lung Cancer (SCLC) were also presented at this ASCO. SCLC accounts for 15% of lung cancer patients, and in the case of diastolic SCLC with metastasis, life expectancy is quite low (about 2 to 4 months).
Unlike the previous AACR for secondary treatment patients, ASCO was conducted for the primary treatment purpose, and the results of combination trials with cytotoxic anticancer drugs were meaningful with 63% of 6-month ORR and 85% of DCR.
The phase 2 clinical results for soft tissue sarcoma that failed 1st line treatment were also very meaningful with ORR 18.75% and DCR 87.5%.
Other clinical trial results have been published including combo trial with TACE (hepatocellular carcinoma), Docetaxel (NSCLC), Temozolomide (melanoma), and Rivoceranib (cholangiocarcinoma, monotherapy).
HLB, which has previously seen excellent DCR through clinical trials of Rivoceranib, has acquired Rivoceranib's global rights, including China, from Advenchen Laboratories. Accordingly, royalties will be collected based on last year’s sales. Rivoceranib reported sales of 2.1 billion yuan (about $ 296 Million) last year as a gastric cancer treatment in China alone, so royalty revenue is expected to increase further when it is marketed.
The securities industry also highly rated Rivoceranib's marketability. Byung-Yong Oh, a researcher at Hanyang Securities, said, “It is very unusual for such an international cancer society to release so many clinical results for an anticancer drug” And added, ”As the efficacy of Rivoceranib has been proven for various indications, HLB will be a useful signal to confirm the commercialization direction and it is expected that the value chain will be expanded through a rapid expansion of indications after global marketing.”