ERYTECH undertakes Phase 3 trial of TRYbeCA-1 for 2L pancreatic cancer

  • IDMC recommends trial to continue to conclusion; results expected by fourth quarter of 2021.
  • According to previous IDMC reviews, no safety issues were observed and identified with use of these.

France-based clinical stage biopharmaceutical company, ERYTECH Pharma has reportedly announced that the Phase 3 clinical trial of its TRYbeCA-1 for second line of pancreatic cancer would continue without any alteration following a planned interim analysis conducted by an Independent Data Monitoring Committee (IDMC).

For the record, ERYTECH is currently engaged into development of innovative therapies by encapsulating therapeutic drug substances inside RBCs.

As per official sources, the short-term analysis was generated when 2/3rd of the total number of events had taken place that allowed the potential for concluding the trial in its early stages if the primary endpoint surpassed its statistical significance, adjusting the threshold for the interim review.

Moreover, it would be crucial to mention that with the previous three reviews put forth by the IDMC, no safety issues were brought up and the Company continues to remain blinded to the primary as well as secondary endpoint efficiency data and statistics. Besides, the TRYbeCA-1 trial is fully enrolled and ERYTECH continues to anticipate the final analysis by the fourth quarter of this year.

Commenting on the recent move, CEO of ERYTECH Pharma, Gil Beyen, stated that the company is pleased to have no issues being raised against TRYbeCA-1 by IDMC reviews. He added that the trial would now continue to the final analysis, whose results are awaited by Q4 2021.

With over 512 patients enrolled, the clinical trial has about 90% power to identify the trial’s design hazard ration of 0.725. He also added that the ERYTECH is hopeful that TRYbeCA-1 can potentially confirm the survival benefits from second line of pancreatic cancer that the company observed in Phase 2B clinical trial.

Source Credit: http://www.globenewswire.com/news-release/2021/02/08/2171019/0/en/ERYTECH-Announces-TRYbeCA-1-Phase-3-Trial-in-2L-Pancreatic-Cancer-to-Continue-to-Final-Analysis.html