ABL Bio (298380) has received a positive signal for its first U.S. Food and Drug Administration drug approval.
ABL Bio announced on the 17th that partner company NovaBridge Bioscience (formerly iMAP) confirmed the possibility of accelerated approval for gastric cancer treatment "Zivastomig (ABL111)" during a meeting with the FDA. The meeting was based on positive data from a Phase 1b clinical trial evaluating Zivastomig in combination with PD-1 inhibitor nivolumab and chemotherapy.
Following a "Type B" meeting with the FDA, NovaBridge received written meeting minutes containing agreements related to Zivastomig's accelerated approval process. As a result, ABL Bio and NovaBridge decided to use objective response rate (ORR) as the primary endpoint for Zivastomig's accelerated approval. The target for initiating Phase 3 registration trials for accelerated approval application is the fourth quarter of this year. The trial design will be finalized through additional discussions with the FDA.
Industry observers are particularly noting the adoption of ORR rather than overall survival (OS) as the primary endpoint for Phase 3 trials. ORR can be measured immediately once tumors shrink beyond a certain threshold, while OS can only be calculated after patient death. The longer patients survive, the more delayed OS analysis becomes. In contrast, ORR can be evaluated within months after treatment. This means the FDA approval process could be accelerated.
"Zivastomig has demonstrated strong efficacy and safety not only in Claudin18.2 high-expression but also in low-expression cases, indicating significant market potential," said Lee Sang-hoon, CEO of ABL Bio. "Zivastomig is expected to generate $3 billion in sales in the first-line gastric cancer treatment market in the U.S., five European countries, and Japan alone. If indications are expanded to Claudin18.2-positive tumors, the drug could achieve $5 billion in sales."
"We believe Zivastomig has the potential to become both First-in-Class and Best-in-Class in gastric cancer treatment," said Philip Dennis, Chief Medical Officer of NovaBridge. "We will continue discussions with the FDA and do our best to provide treatment options to patients as quickly as possible."