Tempest says that 70 patients have so far been enrolled in the study's 1120 arm and contemporaneous control arm. The analysis looked at data from 40 patients in the TPST-1120 arm against 29 evaluable control group participants. Results for the primary efficacy endpoint of objective response rate (ORR) showed a 74.4% relative improvement for those in the triplet arm versus controls, including a 69.9% relative improvement in confirmed ORR. According to Tempest, both the confirmed and unconfirmed response rates were clinically meaningful. Key secondary endpoints include progression-free survival and overall survival (OS).
The company noted that the number of patients on treatment, as well as on study, "markedly favours" the TPST-1120 arm, at rates of 47.5% and 80%, respectively, compared to 23.3% and 50% for the comparator arm. The addition of TPST-1120 was also well tolerated, with safety data consistent with the control regimen, it added.
"We believe the improvements shown in the TSPT-1120 arm validate the hypothesis of targeting HCC with TPST-1120, as well as the mechanistic basis for combination with both a checkpoint inhibitor and VEGF inhibitor," commented CEO Stephen Brady, adding "we look forward to receiving more data this year, including with respect to potential biomarkers, and to the potential next steps of this program in HCC and other cancers of interest."
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