Elevar Therapeutics Announces Rivoceranib Demonstrated Clinical Effectiveness in Patients with Progressive Recurrent or Metastatic Adenoid Cystic Carcinoma in a Phase 2 Trial

Elevar Therapeutics Announces Rivoceranib Demonstrated Clinical Effectiveness in Patients with Progressive Recurrent or Metastatic Adenoid Cystic Carcinoma in a Phase 2 Trial

Results of open-label, multicenter study will be presented during a poster session at ASCO on June 6

• Rivoceranib represents a potential new treatment option for patients with R/M ACC who have high unmet medical need
• Elevar is evaluating commercialization opportunities for rivoceranib in markets outside of China

Salt Lake City, May 26, 2022 – Elevar Therapeutics, Inc., a fully integrated biopharmaceutical company dedicated to elevating treatment experiences and outcomes for patients who have limited or inadequate therapeutic options, today announced its Phase 2 clinical trial (Study RM-202) evaluating rivoceranib, an orally administered tyrosine kinase inhibitor (TKI), demonstrated clinical effectiveness in patients with progressive recurrent or metastatic adenoid cystic carcinoma (R/M ACC). Elevar will present topline findings at the American Society of Clinical Oncology (ASCO)’s annual meeting on June 6.

This open-label study (NCT04119453) was conducted at 11 sites in the U.S. and South Korea to investigate the efficacy and safety of rivoceranib in patients with progressive R/M ACC, more than half of whom had received prior systemic therapy. Rivoceranib demonstrated meaningful results, with an overall response rate (ORR) of 15.1%, median duration of response (DoR) of 14.9 months, median progression-free survival (PFS) of 9 months and disease control for ³3 months in over 60% of patients, regardless of prior vascular endothelial growth factor (VEGFR) therapy. 

“Elevar is extremely pleased to share topline results of Study RM-202, which demonstrate that rivoceranib represents a potential new treatment option for patients with R/M ACC, who have a high unmet medical need,” said Saeho Chong, chief executive officer of Elevar. “This pivotal study succeeded in demonstrating overall survival benefit and PFS in ACC via rivoceranib. It is also gratifying that rivoceranib demonstrates a favorable safety profile, reflecting adverse events consistent with other VEGFR TKIs.

“Following last week’s release, with partner Luzsana (formerly Hengrui Pharma), of positive Phase 3 hepatocellular carcinoma (HCC) data, we look forward to advancing rivoceranib through the regulatory process as an important option for the treatment of both ACC and HCC. Elevar looks forward to further discussing these noteworthy trial results with our esteemed peers at ASCO.”

ASCO will be held June 3-7 at McCormick Place in Chicago, and online. Details of Elevar’s poster presentation are as follows:

Title: A phase 2 study of the oral vascular endothelial growth factor receptor 2 (VEGFR2) inhibitor, rivoceranib, for recurrent or metastatic (R/M) adenoid cystic carcinoma (ACC)

Abstract Number: 6020

Poster Discussion Session type: Head and Neck Cancer

Date: Monday, June 6, 2022

Time:  1:15-4:15 p.m. CDT (poster display); 4:30-6 p.m. CDT (poster discussion)

With 80 patients, including 53 (66.3%) based in the U.S., Study RM-202 is the largest to date involving a TKI in ACC patients and the first to require progression within 6 months prior to the trial. Rivoceranib, which has been given orphan drug designation in the U.S., is an orally administered small molecule anti-angiogenic, with more than 6,000 patients studied in multiple cancers. Elevar has worldwide commercialization rights for rivoceranib, excluding China.

About ACC

Adenoid Cystic Carcinoma (ACC) is a rare malignancy that occurs within the secretory glands, most commonly in the major and minor salivary glands of the head and neck, but also found in the breast, skin and elsewhere. It is diagnosed in about 4 of every 1 million people each year – representing a combined 3,100 annual cases in the U.S., EU and Japan – and it afflicts more than 200,000 patients throughout the world, accounting for 5 percent to 7 percent of all head and neck malignancies, according to the Adenoid Cystic Carcinoma Research Foundation. There is no approved standard of care for R/M ACC patients. A previous study showed a baseline progression-free survival (PFS) of 2.8 months for ACC (Kang EJ, et al. Clin Cancer Res. 2021;27:5272-5279).

About Rivoceranib

Rivoceranib is the first small-molecule tyrosine kinase inhibitor (TKI) to be approved in gastric cancer in China (December 2014). Rivoceranib is a highly potent inhibitor of vascular endothelial growth factor receptor 2 (VEGFR-2), a primary pathway for tumor angiogenesis. VEGFR-2 inhibition is a clinically validated approach to limit tumor growth and disease progression. Rivoceranib, co-developed by Jiangsu Hengrui Pharmaceuticals Co., Ltd. (JHP) in China and Elevar Therapeutics globally, with the exception of China. It has been studied in more than 6,000 patients worldwide and was well tolerated in clinical trials with a comparable safety profile to other TKIs and VEGF inhibitors. Rivoceranib is currently being studied as a monotherapy and in combination with chemotherapy and immunotherapy.

Clinical studies are underway in multiple tumor types including gastric cancer (as a monotherapy and in combination with paclitaxel), hepatocellular carcinoma (combination with camrelizumab), adenoid cystic carcinoma and colorectal cancer (combination with Lonsurf^®). Orphan drug designations have been granted in gastric cancer (U.S., EU and South Korea), adenoid cystic carcinoma (U.S.) and hepatocellular carcinoma (U.S.). Elevar holds the global rights (excluding China) and has partnered for the development and marketing of rivoceranib with HLB-LS in South Korea. Apatinib is currently approved in China for advanced gastric cancer and in second-line advanced HCC by the Chinese-territory license-holder, JHP, under the brand name Aitan^®.

About Elevar Therapeutics

Elevar Therapeutics (Elevar) is a rapidly growing, fully integrated biopharmaceutical company built on the promise of elevating treatment experiences and outcomes for patients who have limited or inadequate therapeutic options. Elevar’s lead proprietary drug candidates include rivoceranib (apatinib) and Apealea^® (paclitaxel micellar). Rivoceranib, under the name apatinib in China, was developed by Jiangsu Hengrui Pharmaceuticals Co., Ltd. in China and approved in China as a single agent for treatment of gastric cancer in 2014 and second-line advanced HCC in 2020. It has been granted orphan drug designation in the U.S., Europe and South Korea and has been clinically tested in more than 1,000 patients worldwide in numerous cancer indications. Apealea^® (paclitaxel micellar) is a non-Cremophor EL based formulation of paclitaxel that received marketing authorization by the European Commission in November 2018, making it Europe’s first non-Cremophor EL formulation of paclitaxel approved for use in ovarian cancer. Elevar has offices in Utah, California, Ireland and South Korea. Additional information is available at www.elevartherapeutics.com/.