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(Correcting date of announcement to Thursday.)
(Alliance News) - AstraZeneca PLC on Thursday announced that datopotamab deruxtecan has shown "encouraging and durable efficacy" in phase 1 trials.
The Cambridge-based pharmaceutical company said that the drug, jointly produced with Daiichi Sankyo Co Ltd, showed positive results in patients with heavily pretreated HR-positive, HER2-low or negative metastatic breast cancer.
Datopotamab deruxtecan - a specifically engineered TROP2-directed antibody drug conjugate - demonstrated an objective response rate of 27%, according to an independent review. All responses were partial, with 56% of patients achieving stable disease.
The company said safety results were consistent with previous trials of the drug.
The disease control rate in the trial was 85%, with a median progression-free survival of 8.3 months.
"These promising results with datopotamab deruxtecan in such a heavily pretreated patient population support our strong belief that this TROP2-directed antibody drug conjugate has the potential to improve outcomes for patients with HR-positive, HER2-low or negative breast cancer in this, and possibly earlier settings," AstraZeneca Chief Medical Officer Cristian Massacesi said.
The company said that treatment discontinuations occurred in five patients due to "an adverse event". The trial also saw one patient death as a result of dyspnoea, which the company said was not treatment-related.
"Patients with HR-positive, HER2-low or negative metastatic breast cancer who are not eligible for endocrine therapy or have exhausted treatment options have a poor prognosis. These preliminary results with datopotamab deruxtecan in patients with heavily pretreated HR-positive, HER2-low or negative metastatic breast cancer are encouraging and warrant further evaluation in this setting," Funda Meric-Bernstam, investigator in the TROPION-PanTumor01 trial said.
AstraZeneca shares was up 0.1% at 11,322.00 pence per share on Friday morning in London.
By Harvey Dorset, Alliance News reporter
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