Elevar Therapeutics presented a study at ESMO, showing the potential of rivoceranib to treat patients with late-stage gastric cancer, which was is the first multinational phase 3 study after rivoceranib’s approval in China, said Dr. Steven Norton, Elevar Therapeutics’ Vice President of Clinical Development.
Dr Norton said the company will further be analyzing the data and believes that it will support the company’s planned regulatory submissions.
The trial itself enrolled 460 patients total in 12 countries; 308 in the rivoceranib arm and 152 in the placebo arm. In the rivoceranib arm, 186 were 3rd line while 122 were ≥4th line (a pre-specified stratification factor). In the placebo arm, 89 patients were 3rd line while 63 were ≥4th line, the company’s announcement said.
Furthermore, 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 a 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.