Elevar Therapeutics Announces Early Completion of Initial Target Enrollment in Pivotal Phase 2 Study Evaluating Rivoceranib (apatinib) in Adenoid Cystic Cancer (ACC)
SALT LAKE CITY, USA., Nov. 17, 2020 – Elevar Therapeutics, Inc. (“Elevar”), a fully integrated biopharmaceutical company built on the promise of elevating treatment experiences and outcomes for patients who have limited or inadequate therapeutic options, today announced the Company met its initial 55 patient enrollment target for its pivotal Phase 2, open-label, multicenter, clinical trial of rivoceranib (apatinib) in patients with recurrent or metastatic adenoid cystic cancer (ACC) one year ahead of schedule. The Company also announced increasing the target size of the trial to 72 patients and expects to complete enrollment by the end of the year. The Company plans to establish an Expanded Access Program to provide rivoceranib for “compassionate use” in patients with ACC.
“Today’s announcement represents an important step forward in our development and registration strategies for rivoceranib and brings us closer to providing a new potential therapeutic option to patients with recurrent or metastatic adenoid cystic cancer (ACC), a devastating disease with no therapeutic treatment options,” said Steven Norton, Ph.D., chief drug development officer at Elevar Therapeutics. “The rapid pace of enrollment underscores a strong interest by patients and physicians in the potential clinical benefit of rivoceranib in ACC which speaks to the critical unmet need for new treatment options. We are incredibly grateful to the trial participants, investigators and their staff for their commitment to completing enrollment, despite the current COVID-19 global pandemic.”
The Phase 2, open-label, multicenter, single-arm clinical trial of oral rivoceranib is evaluating patients with recurrent or metastatic ACC of all anatomic sites of origin who are not eligible for curative surgery or radiotherapy. Due to an increased level of interest from physicians and patients, Elevar increased enrollment to 72 patients from the originally planned 55 patients. The primary endpoint of the study is the frequency of patients with partial or complete responses to treatment (Objective Response Rate). Secondary objectives include overall survival, progression free survival, duration of response and time to progression.
“The data generated by this clinical program thus far are highly encouraging and also demonstrate the potential rivoceranib holds for recurrent and metastatic patients with adenoid cystic cancer (ACC), who have no current standard treatment options,” said Hyunseok Kang, M.D., associate professor of Clinical Medicine at University California, San Francisco. “I would like to thank my co-investigators for the speed of enrollment of this important study, especially during the ongoing pandemic. I look forward to seeing the trial results.”
Rivoceranib has been granted Orphan Drug designation in the U.S., Europe and South Korea.Additional information can be found at ClinicalTrials.gov (Identifier: NCT04119453).
Requests for access to rivoceranib can only be considered if the patient’s treating physician is committed to, and supportive of, the requested treatment. Physicians seeking help on behalf of their patients may contact Elevar at 801-303-7440.
About Adenoid Cystic Carcinoma
Adenoid cystic cancer (ACC) is a rare form of cancer with a reported 1,200 new cases diagnosed each year in the United States. Elevar is preparing to file for orphan drug designation (fewer than 200,000 patients) in the United States. ACC is considered a slow growing but relentless cancer that is characterized by nerve invasion and metastases. ACC typically occurs in salivary glands but can also occur in secretory glands located in other tissues such as the esophagus, breast and lungs. Although good local control is usually achieved by resection of the primary tumor and adjuvant radiation therapy, more than half of patients eventually have recurrent and/or metastatic disease. Currently, no curative treatments are available for these patients which underscores the need for effective new therapies.
About Rivoceranib (apatinib)
Rivoceranib is the first small-molecule tyrosine kinase inhibitor (TKI) to be approved in gastric cancer (China, Dec 2014). Rivoceranib acts by inhibiting angiogenesis, a critical process in cancer growth and proliferation. Specifically, rivoceranib potently and selectively inhibits VEGFR-2 which mediates the primary pathway for tumor-mediated angiogenesis. Elevar Therapeutics is developing rivoceranib for the treatment of patients with gastric cancer, colorectal cancer, hepatocellular carcinoma, and adenoid cystic carcinoma. It has been granted Orphan Drug designation in the U.S., Europe and South Korea and has been clinically tested in over 1,000 patients worldwide. As a best-in-class therapeutic known for its safety and tolerability, Elevar believes rivoceranib has the potential to significantly improve clinical outcomes in combination with chemotherapeutics and immunotherapy, as well as for maintenance therapy.
About Elevar Therapeutics
Elevar Therapeutics (formerly LSK BioPharma) 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 isthe first small-molecule tyrosine kinase inhibitor (TKI) to be approved in gastric cancer (China, Dec 2014). It has been granted Orphan Drug designation in the U.S., Europe and South Korea and has been clinically tested in over 1,000 patients worldwide. Apealea® (paclitaxel micellar)is a non-Cremophor based formulation of paclitaxel that received market authorization by the European Commission in November 2018, making it Europe’s first non-Cremophor formulation of paclitaxel approved for use in ovarian cancer. Elevar Therapeutics has locations in Utah, California and South Korea, and additional information is available at www.elevartherapeutics.com.
Elevar Media Contact:
Elixir Health Public Relations