Threshold Pharmaceuticals (THLD) Reports Positive Phase 2b Trial of TH-302 in Pancreatic Cancer
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Threshold Pharmaceuticals, Inc. (NASDAQ: THLD) announced that detailed results are now published in the abstract featuring its 214-patient randomized controlled Phase 2b clinical trial evaluating the efficacy and safety of two doses of TH-302, a hypoxia-targeted drug, in combination with gemcitabine compared to gemcitabine alone in patients with first-line advanced pancreatic cancer.
The study reached its pre-specified primary efficacy endpoint with a median increase in progression-free survival (PFS) from 3.6 months to 5.6 months in the pooled patients treated with TH-302 (at a dose of 240 mg/m2 or a dose 340 mg/m2) in combination with gemcitabine compared to gemcitabine alone. The combination regimen was also associated with an increase in tumor response rate from 12% to 22% and a greater decrease in serum CA19-9. In addition, a dose response was identified with the greatest efficacy in the higher 340 mg/m2 group with a median PFS of 6.0 months, response rate of 27% and larger CA19-9 decreases. TH-302-related toxicities were also dose dependent. TH-302 related toxicities including skin and mucosal toxicities and myelosuppression were dose dependent and consistent with previous trials and did not result in an increase in discontinuations due to adverse events.
The median PFS was 5.6 months for pooled patients treated with gemcitabine in combination with TH-302 at either 240 mg/m2 or 340 mg/m2 compared to 3.6 months for patients treated with gemcitabine alone. The PFS hazard ratio comparing the TH-302 combination to gemcitabine alone was 0.61 (95% confidence interval: 0.43 - 0.87), which was highly statistically significant (p = 0.005). The median PFS was 6.0 months in the 340 mg/m2 group. The response rate in the pooled combination arms was 22% compared to 12% in the gemcitabine alone group with a 17% response rate in the 240 mg/m2 group and 27% response rate in the 340 mg/m2 group. A similar dose dependency was reported in serum CA19-9 levels.
The study reached its pre-specified primary efficacy endpoint with a median increase in progression-free survival (PFS) from 3.6 months to 5.6 months in the pooled patients treated with TH-302 (at a dose of 240 mg/m2 or a dose 340 mg/m2) in combination with gemcitabine compared to gemcitabine alone. The combination regimen was also associated with an increase in tumor response rate from 12% to 22% and a greater decrease in serum CA19-9. In addition, a dose response was identified with the greatest efficacy in the higher 340 mg/m2 group with a median PFS of 6.0 months, response rate of 27% and larger CA19-9 decreases. TH-302-related toxicities were also dose dependent. TH-302 related toxicities including skin and mucosal toxicities and myelosuppression were dose dependent and consistent with previous trials and did not result in an increase in discontinuations due to adverse events.
The median PFS was 5.6 months for pooled patients treated with gemcitabine in combination with TH-302 at either 240 mg/m2 or 340 mg/m2 compared to 3.6 months for patients treated with gemcitabine alone. The PFS hazard ratio comparing the TH-302 combination to gemcitabine alone was 0.61 (95% confidence interval: 0.43 - 0.87), which was highly statistically significant (p = 0.005). The median PFS was 6.0 months in the 340 mg/m2 group. The response rate in the pooled combination arms was 22% compared to 12% in the gemcitabine alone group with a 17% response rate in the 240 mg/m2 group and 27% response rate in the 340 mg/m2 group. A similar dose dependency was reported in serum CA19-9 levels.
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