On 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, reported 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) (Press release, Elevar Therapeutics, MAY 26, 2022, View Source [SID1234615155]). Elevar will present topline findings at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper)’s annual meeting on June 6.

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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 ≥3 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 (Free ASCO Whitepaper)."

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

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.