AstraZeneca Gets CDSCO Panel nod to study Anti-cancer Drug Datopotamab Deruxtecan and Durvalumab

This came after the drug major AstraZeneca presented Phase III clinical study protocol No. D7630C00001 version 2.0 dated 11 September 2023.

The above-mentioned study is a phase III, open-label, randomized study of Datopotamab Deruxtecan (Dato-DXd) with or without Durvalumab Compared with investigator’s choice of chemotherapy (Paclitaxel, Nab-paclitaxel, or Gemcitabine + Carboplatin) in combination with Pembrolizumab in patients with PD-L1 positive locally recurrent Inoperable or Metastatic Triple-negative Breast Cancer (TROPION-Breast05)

Datopotamab deruxtecan (DS-1062; Dato-DXd) is a trophoblast cell surface antigen 2 (TROP2)-directed antibody-drug conjugate (ADC). Datopotamab deruxtecan has a potent antitumor activity.

After trastuzumab deruxtecan binds to HER2 found on malignant cells, it is internalized and linker cleavage occurs through the actions of lysosomal enzymes. After it is released through cleavage, DXd causes targeted DNA damage and apoptosis in cancer cells, due to the ability to cross cell membranes.

Durvalumab injection is in a class of medications called monoclonal antibodies. It works by helping your immune system to slow or stop the growth of cancer cells. Durvalumab is an anticancer antibody that works to promote the antitumor responses mediated by immune cells. By blocking the action of PD-L1, durvalumab exerts its anticancer effects by increasing T-cell activation and enhancing the detection and ablation of tumor cells.

At the recent SEC meeting for Oncology held on 7th and 8th February 2024, the expert panel reviewed Phase III clinical study protocol No. D7630C00001 version 2.0 dated 11 September 2023, presented by drug major AstraZeneca.

After detailed deliberation, the committee recommended the grant of permission to conduct the trial as presented by the firm.

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