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Elevar announces results from the ANGEL trial
Elevar Therapeutics announced data from the ANGEL trial, a randomized phase 3 study of Rivoceranib (also known as Apatinib) plus best supportive care in patients with gastric or gastroesophageal junction cancer who have failed at least 2 prior lines of therapy. This announcement and today’s podium presentation at the European Society for Medical Oncology’s (ESMO) 2019 Congress represent the first detailed public disclosure of ANGEL study data since the announcement of the topline results in June.
“This study demonstrates the potential of Rivoceranib to treat patients with late-stage gastric cancer,” said Dr. Steven Norton, Elevar Therapeutics’ Vice President of Clinical Development, “this is the first multinational phase 3 study after Rivoceranib’s approval in China. We look forward to further analyzing the data and believe that it will support our planned regulatory submissions.”
The trial enrolled 460 patients total in 12 countries; 308 in the Rivoceranib arm and 152 in the placebo arm. In the Rivoceranib arm, 186 were the 3rd line while 122 were ≥the 4th line (a pre-specified stratification factor). In the placebo arm, 89 patients were 3rd line while 63 were ≥4th line.
The median overall survival (mOS) of the full (3rd line and ≥4th line) intention-to-treat (ITT) population was 5.8 months for the Rivoceranib group versus 5.1 months for the placebo arm, a result that did not reach statistical significance (p=0.485). However, the mOS in the ≥4th line was positive and significant (p=0.0195), with an mOS result of 6.3 months for the Rivoceranib arm versus 4.7 months for the placebo arm. The median progression free survival (mPFS) of the full population (3rd and ≥4th line) was also positive at 2.8 months for the Rivoceranib arm versus 1.8 months for the placebo arm, a result that was highly significant (p<0.0001). The mPFS for the ≥4th line was also positive and highly significant (p<0.0001) at 3.5 months for the Rivoceranib arm versus 1.7 months for the placebo arm.
The objective response rate in patients randomized with measurable disease was about 7% and the disease control rate was 42%, in alignment with what was observed in Phase 3 Chinese study that supported the market approval in China. As expected, Rivoceranib was generally well tolerated in the ANGEL study with a manageable safety profile.