Elevar Therapeutics will announce the
results of phase 2 Rivoceranib clinical trials for Adenoid Cystic Carcinoma
(ACC) at the 2022 American Society of Clinical Oncology Annual Meeting (2022
ASCO).
The following clinical trial was conducted on
72 patients with recurrent or metastatic ACC in South Korea and the United
States. Elevar will operate a separate booth (#28089) during the meeting and
introduce various pipelines and efficacy of Rivoceranib to clinicians and
multinational pharmaceutical companies around the world.
ACC is a rare disease that occurs more than
1,200 patients every year in the United States alone. Until now, it has been an
intractable disease with no suitable treatments other than repetitive surgery
or radioactive treatment. Rivoceranib, designated as an orphan drug by the FDA
in February last year, is likely to receive New Drug Application (NDA) approval
without phase 3 clinical trials.
Elevar began administering the first
patient in March 2020. Initially, it aimed to recruit 55 patients, but expanded
it to 72 at the request of specialists
and patients. The clinical trials were conducted at seven organizations,
including the University of California, San Francisco (UCSF), Dana-Farber
Cancer Institute, and the University of Michigan, as well as Korean
institutions such as Seoul National University Hospital, Asian Medical Center,
Samsung Medical Center, and National Cancer Center. The primary endpoint was
Overall Response Rate (ORR), and the secondary endpoint was Overall Survival
(OS), Progression-Free Survival (PFS), and Disease Control Rate (DCR).
The development of first line ACC treatment
is one of the most important treatments for HLB in Korea, which has vowed to proceed
with two cases of NDA within a year.
In addition to ACC, the third phase of
global clinical trials for Hepatocellular Carcinoma (HCC), undergoing combination therapy with
Rivoceranib and Camrelizumab (PD-1 inhibition), are also expected to end this
year.
In-Keun Jang, Vice-President of HLB’s Bio
Strategic Planning Team said, "In addition to the presentation at ASCO, hundreds
of papers demonstrate the superior efficacy and safety of Rivoceranib for
various cancers in succession” and said, “for many patients who are suffering
from lack of proper treatment and looking forward to an innovative new drug, we
will do our best to get accelerated approval from FDA”.
He also added “the announcement at ASCO will mark the most important milestone for HLB to become a global pharmaceutical company”.