On June 6, 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 the results of its Phase 2 clinical trial (Study RM-202) of rivoceranib, an orally administered tyrosine kinase inhibitor (TKI), in patients with progressive recurrent or metastatic adenoid cystic carcinoma (R/M ACC) (Press release, Elevar Therapeutics, JUN 6, 2022, View Source [SID1234615682]).

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As shared in a poster presentation at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) annual meeting, the results of Study RM-202 demonstrate the clinical effectiveness of rivoceranib for the treatment of patients with progressive R/M ACC, as indicated by substantially reduced tumor progression during the 6 months after rivoceranib treatment compared to that during the 6 months prior to rivoceranib treatment [-7.0 (-43 to 35) mm vs. 20.5 (5 to 180) mm].

The 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. 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.

All 80 participants demonstrated tumor progression within 6 months prior to the trial (by requirement). The study found an overall response rate (ORR) of 15.1% (a 30% reduction based on RECIST), and though not a study endpoint, the remaining 85% of patients had a reduction of tumor size.

"With every participant exhibiting a recent growing lesion upon entering this Phase 2 trial of rivoceranib, these results demonstrate significant clinical effectiveness and rivoceranib’s promise as a potential new treatment for patients with R/M ACC," said Saeho Chong, chief executive officer of Elevar. "Our entire Elevar team is greatly encouraged by these results, and we are fully focused on advancing rivoceranib through the regulatory process."

Other Study RM-202 key findings:

52% of patients had a response according to CHOI (size or density); CHOI is believed to be more correlated with median overall survival (mOS) than RECIST v1.1 (size only)
CHOI for Response: >10% reduction in tumor size or >15% reduction in tumor density
Median duration of response (mDoR) of 14.9 months
Median progression-free survival (mPFS) of 9 months versus published data of a baseline of 2.8 months for R/M ACC, and disease control for ≥ 3 months in over 60% of patients, regardless of prior vascular endothelial growth factor (VEGFR) therapy
Rivoceranib adverse event profile similar to other TKIs
"There is no approved standard of care for R/M ACC, so as we investigate rivoceranib’s potential as a treatment option we remain steadfastly focused on the many patients who now have or someday will be diagnosed with this disease," said Dr. Hyunseok Kang, medical oncologist at the University of California San Francisco and the primary investigator for Study RM-202. "The positive results demonstrated in this Phase 2 trial of rivoceranib represent a vitally important step forward for them."

Rivoceranib, which has been given orphan drug designation in the U.S., is a 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.