BARCELONA, Spain — Rivoceranib failed to significantly improve OS in an overall study population with advanced gastric cancers, according to results of the randomized phase 3 ANGEL study presented at European Society for Medical Oncology Congress.
However, the study did meet secondary endpoints, including significantly extending PFS, increasing overall response rate and improving OS in the fourth-line setting.
These results suggest rivoceranib (LSK BioPharma) — referred to as apatinib in China — may still offer clinical benefit, Min-Hee Ryu, MD, PhD, professor of oncology in the department of oncology at University of Ulsan College of Medicine in South Korea, and colleagues concluded.
“Rivoceranib, a tyrosine kinase inhibitor of VEGFR-2, demonstrated efficacy [in the third line and above] and [was approved] as a treatment for gastric cancers in China,” Ryu said during a presentation. “[It also] demonstrated efficacy [among] patients with gastric cancer outside of China. However, it had not previously been evaluated in a global randomized placebo-controlled study.”
Ryu and colleagues randomly assigned 460 patients (median age, 60 years; range, 21-91; 353 male) with advanced or metastatic adenocarcinoma of the stomach or gastroesophageal junction to best supportive care plus either rivoceranib dosed at 700 mg daily (n = 308) or placebo (n = 152). Treatment continued until disease progression or intolerable toxicity.
All patients had failed at least two prior lines of chemotherapy and were stratified by geographic region, disease measurability, prior ramucirumab use and treatment therapy line.
OS in the intent-to-treat population served as the primary endpoint. PFS, objective response rates, disease control rate, quality of life and safety served as secondary endpoints.
Median follow-up was 13.7 months in the rivoceranib group and 12.1 months in the placebo group.
Results showed patients who received rivoceranib achieved longer median OS, but the difference did not reach statistical significance (5.8 months vs. 5.1 months; HR = 0.93; 95% CI, 0.74-1.15).
However, rivoceranib-treated patients did achieve significantly longer median PFS (2.83 months vs. 1.77 months; HR = 0.57; 95% CI, 0.46-0.79), a higher objective response rate (6.87% vs. 0%; P = 0.002), and a higher disease control rate (42.4% vs. 13.1%; P < 0.0001).
Additionally, rivoceranib significantly increased OS among patients being treated in the fourth-line setting (6.43 months vs. 4.73 months; HR = 0.65; 95% CI, 0.46-0.92).
The most common treatment-related adverse events experienced by rivoceranib-treated patients included hypertension (34.2%), proteinuria (29.3%), and hand-foot skin reaction (26.4%).
“The primary endpoint was not met in this trial [but] these findings suggest that rivoceranib has a benefit with a favorable safety profile in gastric cancer,” Ryu said. – by John DeRosier
Kang YK, et al. Abstract LBA43. Presented at: European Society for Medical Oncology; Sept. 27 -Oct. 1, 2019; Barcelona, Spain.
Disclosure s : LSK BioPharma funded this study. Ryu reports no relevant financial disclosures. Please see the abstract for all other authors’ relevant financial disclosures.