Zynlonta’s confirmatory Phase 3 readout in DLBCL undermined the path to full approval, with ADC Therapeutics reporting 27 deaths in the treatment arm versus nine in the control arm and no overall survival benefit. The safety profile in LOTIS-5 has complicated investor and physician expectations for the drug’s risk-benefit profile. Separately, Innovaent reported Phase 3 interim success for its CLDN18.2 ADC arcotatug tavatecan in advanced gastric cancer. The company submitted an NDA to China’s NMPA for previously treated, CLDN18.2-positive patients and said the application was accepted with priority review. The two updates illustrate how oncology development continues to be driven as much by safety signal interpretation and endpoint credibility as by efficacy. They also reinforce that platform and target validation can accelerate timelines even when other ADC assets face tightening scrutiny.
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