NTRA News & Events

Natera (NTRA) highlighted Allogene Therapeutics' (ALLO) interim futility analysis from its registrational ALPHA3 trial for cemacabtagene ansegedleucel, an investigational allogeneic anti-CD19 CAR T therapy, in first-line consolidation large B-cell lymphoma, LBCL. The interim analysis showed that 58.3% of MRD-positive patients treated with cema-cel achieved MRD clearance. In addition, at the Day-45 MRD assessment, plasma ctDNA levels decreased from baseline by a median of 97.7% in the cema-cel arm compared to a 26.6% median increase in the observation arm, suggesting molecular disease progression due to lack of intervention. These findings provide early evidence that cema-cel may help prevent or delay clinical relapse for LBCL patients with MRD.

Natera provided an update on a recent decision issued by the U.S. District Court in the District of Delaware regarding Natera's litigation with ArcherDx and Invitae. In a decision issued April 6, the Court ordered an ongoing royalty to Natera of 30% on post-injunction revenues from infringing MRD-related product sales that fall within the exceptions to the injunction, which was issued by the Court on November 21, 2023. The jury had awarded an effective royalty of 20.5% on pre-injunction revenues, which remains unchanged. With respect to the non-MRD products, the jury's verdict of patent validity and direct infringement also remains intact. Natera has over 650 issued or pending patents.