Tempest soars on new ORR data for TPST-1120 in first-line liver cancer
11 Oct 2023
Clinical ResultPhase 1License out/in
Shares in Tempest Therapeutics were up more than seven-fold on Wednesday after the company reported updated Phase Ib/II study results for its oral PPAR⍺ antagonist TPST-1120, showing a near doubling of objective response rate (ORR) in patients with liver cancer, compared with the previous data cut. "This comprehensive analysis of more mature clinical data shows an even greater benefit than the earlier interim analysis of the TPST-1120 triplet therapy over standard of care alone, both for the entire study population and in subpopulations," said CEO Stephen Brady.
The trial randomised 70 patients with first-line unresectable or metastatic hepatocellular carcinoma (HCC)unresectable or metastatic hepatocellular carcinoma (HCC) to receive TPST-1120 combined with Roche's PD-L1 inhibitor Tecentriq (atezolizumab) plus the anti-VEGF antibody Avastin (bevacizumab), or Tecentriq and Avastin alone. The companies are collaborating on the study via an agreement struck in 2021, with Roche managing study operations, although Tempest retains all rights to TPST-1120. The primary efficacy endpoint is ORR, while key secondary goals include progression-free survival (PFS) and overall survival (OS).
Tempest said the confirmed ORR achieved in patients given TPST-1120 in this latest readout, done after a median follow-up of roughly 9 to 10 months, was 30% versus 13.3% for controls. The cut-off date for these data was April 20 of this year. This compares to a previous data cut of 17.5% versus 10.3% for the TPST-1120 and control arms, respectively (for more, see KOL Views Q&A: Leading oncologist intrigued by TPST-1120 in HCC despite caveats). Duration of response has not yet been reached, Tempest noted about the latest findings.
Aiming for pivotal study
The company also said hazard ratios (HR) for key survival endpoints also favoured TPST-1120. Median PFS was 7 months for TPST-1120 versus 4.3 months for the control arm, while median OS was not reached for the TPST-1120 arm, and was 15.1 months for controls. HR values for PFS and OS were 0.7 and 0.59, in both cases favouring TPST-1120, but the data are not yet mature.
Meanwhile, Tempest reported that subgroup data were "consistent with the mechanism of action of TPST-1120." Specifically, patients with b-catenin activating mutations, who made up about one-fifth of the study population, showed a confirmed ORR of 43% and disease control rate of 100% in the TPST-1120 arm. In addition, the TPST-1120 arm was "consistently active" across both PD-L1-positive and -negative tumoursPD-L1-positive and -negative tumours, with a confirmed ORR of 27% seen with Tempest's drug versus 7% for the control arm in PD-L1-negative tumoursPD-L1-negative tumours. The updated results will be presented at a medical meeting at a later date.
Poison pill
Separately on Wednesday, Tempest also said its board adopted a limited-duration stockholder rights plan with a 10% trigger. The company noted that the board did not adopt the rights plan in response to a specific takeover threat.
Highlighting the new HCC data, Brady stated that "unfortunately, Tempest, like many other biotechnology companies, continues to experience a significant and ongoing dislocation in the trading price of its common stock." He said the rights plan, which takes immediate effect and expires next October, "should reduce the likelihood that any person or group gains control of Tempest through open market accumulation without paying all stockholders an appropriate control premium or without providing the board sufficient time to make informed judgments."
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