Earlier this week, AstraZeneca shared positive high-level results from its phase 3 trial evaluating its antibody-drug conjugate (ADC) candidate for the treatment of non-small cell lung cancer (NSCLC).
Jointly developed with Daiichi Sankyo, datopotamab deruxtecan (Dato-DXd) is a TROP2-directed DXd ADC, designed to target a protein called TROP2 found in cancer cells. Dato-DXd is made up of an antibody that recognizes TROP2 and a medication that can kill cancer cells attached to it.
In its global, randomized, multicenter, open-label phase 3 trial, TROPION-Lung01, the drug was evaluated for safety and efficacy in approximately 600 patients with locally advanced or metastatic NSCLC, with or without actionable genomic alterations, who had been treated with at least one prior therapy.
The study met its dual primary endpoints of progression-free survival and assessed overall survival with key secondary endpoints including objective response rate, duration of response, time to response, and disease control rate. Dato-DXd showed significant improvement in progression-free survival compared to standard chemotherapy in patients with advanced local or metastatic disease.
It's been 23 years since the FDA approved the first antibody-drug conjugate. While the cancer-destroying modality struggled initially with dosage and toxicity issues, conjugation technology, as well as drugmaker experience, has come a long way. With many of the initial kinks smoothed, pharma’s stage has been lit up with ADC deal-making.