AstraZeneca to study cancer drug Datopotamab deruxtecan in India

New Delhi: In a significant development, major drug-maker AstraZeneca has got the go ahead from the Subject Expert Committee (SEC) functional under the Central Drugs Standard Control Organization (CDSCO) to conduct a Phase 3 clinical trial of oncology drug Datopotamab deruxtecan (Dato-DXd, DS1062a)100mg.

This comes in the wake of the Phase III clinical trial protocol presented by AstraZeneca at the recent SEC meeting for Oncology and Haematology.

Datopotamab Deruxtecan, is a novel Trophoblast cell surface antigen 2 (TROP2) -directed Antibody-drug Conjugate which demonstrates potent antitumor activity by efficient drug delivery to tumor cells.

Dato-DXd bound specifically to TROP2 and was internalized into tumor cells followed by intracellular trafficking to lysosome and DXd release, which induced DNA damage and apoptosis in TROP2-expressing tumor cells in vitro. 

The pharmacologic activity and mechanism of action of Dato-DXd were investigated in several human cancer cell lines and xenograft mouse models including patient-derived xenograft (PDX) models. Safety profiles were also assessed in rats and cynomolgus monkeys.

At the recent SEC meeting, the committee noted that the safety profile of the study drugs from preclinical toxicology studies including repeat dose toxicity study and Phase I &II clinical study data justify the conduct of the trial.

In accordance with the innovation vis-à-vis existing therapeutic option, the committee observed that the purpose of the study is to demonstrate the superiority of Dato-DXd compared to ICC by assessment of PFS in participants with inoperable or metastatic HR-positive, HER2-negative breast cancer, who have been treated with 1 or 2 lines of chemotherapy in the inoperable/metastatic setting, per BICR.

Furthermore, the expert panel noted that in line with the unmet Medical need in the country the test drug may potentially provide treatment in patients with Inoperable or Metastatic Hormone Receptor-Positive, HER2-Negative Breast Cancer who have been treated with one or two prior lines of systemic chemotherapy. 

In view of the above, after detailed deliberation, the committee recommended the grant of permission to conduct the study.