ESMO26: Takeda preps filings on CLDN18.2 gastric cancer data
Takeda has reported positive results from its phase 3 G-HOPE-001 trial of anti-CLDN18.2 drug arcotatug tavatecan (TAK-921) in advanced gastric cancer, setting up its first egulatory filing outside China.
The study showed that TAK-921 achieved a statistically significant 43% improvement in overall survival, compared to physician's choice of chemotherapy, in patients with CLDN18.2-positive, previously treated, advanced gastric or gastroesophageal junction adenocarcinoma (G/GEJA).
Median OS was 10.2 months with the antibody-drug conjugate (ADC), versus 6.9 months in the control group, and progression-free survival (PFS) was also significantly extended – coming in at 7.1 months versus 3.1 months in the control group – which equated to a 55% improvement.
TAK-921 originates from Takeda's massive $11.4 billion 2025 alliance with Innovent Biologics, which has already filed for approval of the ADC in its home market, China, and is waiting for the outcome of a priority review by the National Medical Products Administration (NMPA).
As G-HOPE-001 enrolled patients from China and Japan, Takeda said it plans to use the new data to support a filing in the latter market, as it pursues development of TAK-921 in other world markets.
If approved, TAK-921 would be a rival to Astellas' Vyloy (zolbetuximab), the first CLDN18.2-directed drug to reach the market, which is approved in most major markets for use in combination with chemo as a first-line treatment for locally advanced unresectable or metastatic CLDN18.2-positive G/GEJA.
"People with advanced gastric cancer whose disease has progressed after multiple prior therapies face limited treatment options and poor survival outcomes," said Kohei Shitara of National Cancer Centre Hospital East in Kashiwa, Japan, and a G-HOPE-001 investigator.
"Arcotatug tavatecan helped patients live longer and significantly extended the time without disease progression compared with commonly used later-line treatments," he added.
"Together with its manageable safety profile, these findings highlight the potential for arcotatug tavatecan to offer meaningful clinical benefit and become an important new treatment option for patients with advanced CLDN18.2-positive gastric cancer."
Takeda said it plans to initiate international phase 3 trials of TAK-921 in both gastric and pancreatic cancer on the back of its proof-of-concept studies.
The Japanese group paid $1.2 billion upfront for rights to TAK-92 and a bispecific antibody targeting PD-1 and IL-2 alpha in its deal with Innovent, with an option on a third candidate, a bispecific ADC targeting EGFR and B7H3.
Photo by julien Tromeur on Unsplash
