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.”