Aug 28 (Reuters) - BioNTech SE said on Friday it has decided to terminate the mid-stage trial of its experimental mRNA-based cancer vaccine for patients with a type of colorectal cancer, sending the German firm's U.S.-listed shares down nearly 9%.
An independent data safety monitoring board, responsible for overseeing the safety and integrity of the trial, recommended discontinuing treatment of patients and terminating the study.
The immunotherapy, autogene cevumeran, is being jointly developed by BioNTech and Roche's Genentech. The trial was evaluating it as an adjuvant monotherapy in patients with high-risk stage II or stage III colorectal cancer whose tumors had been surgically removed but who remained ctDNA-positive.
In its most recent review of the available data of this trial, the board identified a numerical imbalance in overall survival between treatment arms in this specific patient population and noted that further trial continuation was unlikely to change the efficacy outcome.
(Reporting by Sriparna Roy in Bengaluru; Editing by Shilpi Majumdar)
#patients #colorectal
An independent data safety monitoring board, responsible for overseeing the safety and integrity of the trial, recommended discontinuing treatment of patients and terminating the study.
The immunotherapy, autogene cevumeran, is being jointly developed by BioNTech and Roche's Genentech. The trial was evaluating it as an adjuvant monotherapy in patients with high-risk stage II or stage III colorectal cancer whose tumors had been surgically removed but who remained ctDNA-positive.
In its most recent review of the available data of this trial, the board identified a numerical imbalance in overall survival between treatment arms in this specific patient population and noted that further trial continuation was unlikely to change the efficacy outcome.
(Reporting by Sriparna Roy in Bengaluru; Editing by Shilpi Majumdar)
#patients #colorectal
2 months ago
