RE: Daiichi Sankyo takes $610M profit hit linked to ADC manufacturing overbuild9 May 2026 16:09
More about Daiichi's deruxtecan trials from that report:
"TROP2-directed Datroway, Daiichi’s second ADC from its AZ collaboration to reach the market, showed limited efficacy in second-line non-small cell lung cancer, leading to a revised FDA application and eventual go-ahead in an EGFR-mutated niche last summer.
"Based on learnings from the readout, Daiichi and AZ tweaked several of Datroway’s phase 3 trials, including the closely watched Avanzar study in first-line NSCLC, to include analyses of an AI-enabled TROP2-related biomarker as a primary endpoint.
" “Based on the totality of data that we’ve seen so far across multiple data sets, we’ve seen consistent improvement in performance for both [progression-free survival] and [overall survival] in the biomarker-positive patient population, both as monotherapy and in combination with [immuno-oncology] in a first-line setting,” AZ’s oncology R&D chief Susan Galbraith, Ph.D., said on the company’s first-quarter earnings call last week.
"In addition, the launch timeline of Daiichi and partner Merck & Co.’s HER3 ADC, patritumab deruxtecan, looks significantly delayed, if the agent ever reaches the market at all. Following an FDA rejection in 2024 due to problems at a contractor’s manufacturing facility, the pair last year pulled an application because of an overall survival miss in EGFR-mutated NSCLC. In its Merck partnership, Daiichi is responsible for manufacturing.
"Meanwhile, another Merck-partnered Daiichi project, B7-H3 ADC ifinatamab deruxtecan (I-DXd), is awaiting an FDA decision for previously treated extensive-stage small cell lung cancer by Oct. 10, 2026. However, competition in the B7-H3 space is heating up."
https://www.fiercepharma.com/pharma/daiichi-sankyo-takes-610m-profit-hit-linked-adc-manufacturing-losses