Adaptimmune Therapeutics is on track to bring the first engineered T-cell therapy to market in a solid tumor indication. With the response rate above the target threshold at the interim analysis, the biotech is certain the study will hit its primary endpoint and deliver the data needed to seek approval next year.
As of the start of September, 16 of the 47 evaluable sarcoma patients had responded after receiving a single dose of MAGE-A4 TCR T-cell therapy afami-cel. The 34% response rate is down on the figure reported over the summer but still well above the 18% achieved by historical second-line therapies. If the lower bound of the confidence interval tops 18%, the trial will meet its primary endpoint.