Rivoceranib Clinical Results Presented at ASCO... Highlighting Potential for Expanded Therapeutic Applications

At the annual meeting of the American Society of Clinical Oncology (ASCO), the world's largest cancer conference, investigator-initiated clinical trial results related to Rivoceranib were presented. The academic value of Rivoceranib and its potential for expansion into various indications were highlighted.

On June 4, HLB announced that a total of 15 investigator-initiated clinical trials involving Rivoceranib were presented at the ASCO annual meeting, which concluded on June 3 (local time). These trials targeted a total of nine cancer types, including head and neck cancer, biliary tract cancer, and gastric cancer, and evaluated Rivoceranib either as monotherapy or in various combination regimens.

The most notable trial was a phase 2 investigator-initiated study evaluating the efficacy and safety of the combination of Rivoceranib and Camrelizumab as a first-line treatment for recurrent or metastatic head and neck squamous cell carcinoma. The median overall survival (mOS), which was the primary endpoint, was 21 months for the Rivoceranib plus Camrelizumab combination, significantly longer than the 16.4 months for Camrelizumab plus chemotherapy. This result also surpassed the mOS of 13 months for the combination of Keytruda (pembrolizumab) and chemotherapy, which is an approved regimen, drawing significant attention.

The clinical trial demonstrated that the combination of Rivoceranib and Camrelizumab has meaningful therapeutic potential as a first-line treatment for recurrent or metastatic head and neck squamous cell carcinoma.

Another trial was a phase 2 investigator-initiated study evaluating the efficacy of Rivoceranib and Camrelizumab combination therapy in patients with advanced or recurrent chordoma (a type of spinal tumor). The objective response rate (ORR), the primary endpoint, was 21.2% (95% CI 9.0-38.9), and the median progression-free survival (mPFS) was 18.1 months (95% CI 11.0-28.5).

Currently, there are no approved therapies for chordoma. The National Comprehensive Cancer Network (NCCN) guidelines also do not recommend any preferred drugs for this indication. In addition, considering that the mPFS for imatinib, one of the existing treatment options, has been reported to be about 9 months, the combination of Rivoceranib and Camrelizumab presents a meaningful therapeutic alternative for patients with chordoma.

Among the monotherapy trials, an investigator-initiated study evaluating the efficacy and safety of adjuvant Rivoceranib in high-risk nasopharyngeal carcinoma patients who had completed concurrent chemoradiotherapy (CCTR) drew particular attention.

The 3-year progression-free survival (PFS), the primary endpoint, was 78.6% (95% CI 66.3-90.9) in the Rivoceranib adjuvant group, which was significantly higher than the 54.5% (95% CI 39.8-69.2) in the group that did not receive adjuvant therapy. The 3-year overall survival (OS) was also improved in the Rivoceranib group at 88.1%, compared to 75.0% in the non-treatment group.

These clinical results exceed the 3-year OS of 76% reported for the combination of cisplatin and fluorouracil, which is the adjuvant therapy recommended by the NCCN guidelines for these patients.

Han Yonghae, Chief Technology Officer (CTO) of the HLB Group, stated, "The clinical value of Rivoceranib and its therapeutic potential as both a combination and monotherapy have once again been confirmed," adding, "We have demonstrated the possibility of Rivoceranib as a therapeutic alternative by showing meaningful improvements in survival rates in cancer types with significant unmet medical needs."

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