Takeda discloses pivotal Innovent plans

The ink is barely dry on Takeda’s $1.2bn tie up with Innovent, and the Japanese group is already outlining a raft of global pivotal trials for the assets involved, the anti-PD-1 x IL-2 fusion protein IBI363 and the Claudin18.2-targeting ADC arcotatug tavatecan. In its second-quarter earnings presentation, Takeda revealed plans for three more worldwide phase 3 trials of IBI363, on top of the just-begun MarsLight-11 study, in squamous NSCLC following anti-PD-(L)1 therapy and chemo. One of the upcoming studies will enrol non-squamous second-line NSCLC patients, while the others will be in first-line NSCLC and microsatellite stable colorectal cancer. Meanwhile, arcotatug tavatecan (IBI343) is heading for global phase 3s in first-line Claudin18.2-positive pancreatic ductal adenocarcinoma and gastric cancer. Innovent is already carrying out Chinese trials in third-line gastric (G-Hope-001) and pancreatic (G-Hope-002) cancers, set to complete in 2026 and 2027 respectively. Takeda needed an oncology boost after the discontinuation of its cell therapy business earlier this month. However, Claudin18.2 is crowded, and there could be doubts about IBI363 following various failures of cytokine approaches. Data presented at ASCO on IBI363 were promising, although toxicity looked high and will remain closely watched.

Takeda’s global phase 3 plans for Innovent assets

Source: Company presentation.