AstraZeneca's Datroway Approved for Drug-Resistant Lung Cancer

AstraZeneca's ADC drug Datroway has received approval from the U.S. Food and Drug Administration (FDA) for the treatment of locally advanced or metastatic EGFR-mutated non-small cell lung cancer (NSCLC) in adult patients who have previously received EGFR-targeted therapy and platinum-based chemotherapy. This approval marks a significant milestone as it is the first drug approved in the U.S. for this specific type of lung cancer.

The approval is based on the results of two clinical trials, TROPION-Lung05 and TROPION-Lung01, which involved 114 patients who had progressed after receiving EGFR-targeted therapy and platinum-based chemotherapy. The trials demonstrated an objective response rate (ORR) of 45% and a median duration of response (DoR) of 6.5 months. These findings highlight the potential of Datroway in treating this type of drug-resistant NSCLC.

The TROPION-Lung05 trial was a global, multicenter, single-arm study that evaluated the efficacy and safety of Datroway. The primary endpoint was the ORR as assessed by blinded independent central review (BICR). The TROPION-Lung01 trial was a global, randomized, multicenter, open-label study that compared the efficacy and safety of Datroway to docetaxel. The dual primary endpoints were progression-free survival (PFS) as assessed by BICR and overall survival (OS).

Datroway is a TROP2-directed antibody-drug conjugate (ADC) developed using Daiichi Sankyo's proprietary DXd ADC technology. It consists of a humanized anti-TROP2 IgG1 monoclonal antibody linked to a topoisomerase I inhibitor payload via a cleavable tetrapeptide linker. This technology has already been approved in over 30 countries for the treatment of adult patients with unresectable or metastatic hormone receptor-positive, HER2-negative breast cancer who have previously received endocrine therapy and chemotherapy.

Following the FDA approval, AstraZeneca will pay Daiichi Sankyo a milestone-related fee of $45 million. This collaboration between AstraZeneca and Daiichi Sankyo underscores their commitment to developing innovative treatments for patients with advanced cancers. The approval of Datroway provides a new treatment option for patients with EGFR-mutated NSCLC who have exhausted other therapeutic avenues, offering hope for improved outcomes in this challenging patient population.