On November 19, 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, reported new clinical results from its Phase 1 study evaluating rivoceranib (apatinib) in combination with nivolumab in patients with locally advanced unresectable or metastatic solid tumors will be presented in an oral session at the virtual 2020 Connective Tissue Oncology Society "CTOS" annual meeting being held November 18-20, 2020 (Press release, LSK BioPharma, NOV 19, 2020, View Source [SID1234571415]).
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"We are encouraged by these initial Phase 1 results, which demonstrate a compelling safety profile and provide early evidence that rivoceranib may enhance the efficacy of commonly used FDA-approved systemic therapies, including checkpoint inhibitors such as nivolumab," said Steven Norton, Ph.D., chief drug development officer of Elevar Therapeutics. "With encouraging preliminary activity, including prolonged disease control, objective tumor responses, and progression-free survival rates, the results of this study reinforce the potential clinical rationale for combining rivoceranib with nivolumab for a range of difficult-to-treat solid tumors. We look forward to the continued development of this promising combination treatment regimen."
A total of 30 patients were recruited for the two-part study, which contained a dose escalation phase (Part I) followed by a dose expansion phase (Part II). In Part I, ten patients received escalating doses of rivoceranib starting at 400 mg in combination with nivolumab at 240 mg iv q2w. Meanwhile, two additional cohorts received rivoceranib at 300 and 200 mg (concomitant with nivolumab) respectively. In Part II, 20 patients initially received 300 mg rivoceranib in combination with nivolumab therapy at 240 mg q2w. Some received a reduced dose of nivolumab (200 mg) in later treatments. Main eligibility criteria included patients with primary diagnosis of histologic- or cytologic-confirmed solid tumor cancers.
The overall response rate (ORR) was 13.3% (95% CI: 3.8 % to 30.7%), and the disease control rate (complete response, partial response, stable disease) was 76.7% (95% CI: 57.7 % to 90.1 %). The median progression-free survival (PFS) was 7.2 months (95% CI: 5.3 to 9.0 months). Partial response was observed in four patients (13.3%).
Grade 3 and greater treatment-emergent adverse events occurred in 23 (76.7%) patients (7 patients from Part I and 16 patients from Part II). Two patients (6.7%) experienced fatal AEs. The rate of discontinuation was 30.0% and the rate of dose reduction was also 30% due to AEs. There were no unexpected side effects, no additive side effects of the combined treatment (nivolumab and rivoceranib), and no drug related death noted.
Abstract 3465673: Updated Phase I Study to Evaluate the Safety and Efficacy of Rivoceranib (Apatinib) and Nivolumab in Patients with Unresectable or Metastatic Cancer
Date and time: November 19, 2020 from 11:30 AM to 12:30 PM
Session 3: Leiomyosarcoma and Undifferentiated Pleomorphic Sarcoma
About Rivoceranib (apatinib)
Rivoceranib is the 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. 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. 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. Elevar Therapeutics is developing rivoceranib for the treatment of patients with gastric cancer, colorectal cancer, hepatocellular carcinoma, and adenoid cystic carcinoma.