NEW YORK – AstraZeneca and Daiichi Sankyo have begun treating high-risk non-small cell lung cancer patients with their TROP2-directed antibody drug conjugate Datroway (datopotamab deruxtecan) and AstraZeneca's anti-PD-1 and -TIGIT bispecific antibody rilvegostomig in a Phase III trial testing the regimen's activity as an adjuvant treatment.
The trial has three arms comparing Datroway plus rilvegostomig against rilvegostomig alone and against standard-of-care adjuvant treatment with chemotherapy or observation. Researchers will enroll about 660 patients with stage I NSCLC after complete surgical resection who have circulating tumor DNA (ctDNA) or have other high-risk pathological features, including visceral pleural invasion, lymphovascular invasion, or high-grade histology.
"With TROPION-Lung12, we are simultaneously deploying a novel strategy for identifying patients with lung cancer who are at an increased risk of disease recurrence after surgery and evaluating novel treatment options in the adjuvant setting, including rilvegostomig with and without Datroway," AstraZeneca Chief Medical Officer Cristian Massacesi said in a statement. "The ambitious approach in this trial underscores our commitment to both enabling more personalized treatment decisions and delivering innovative treatment options to patients with cancer."
The trial's primary endpoint is disease-free survival following complete tumor resection, and researchers will also assess overall survival, safety, patient-reported physical functions, and patient-reported quality of life outcomes.
Datroway was approved in the US earlier this month for treating hormone receptor (HR)-positive, HER2-negative unresectable or metastatic breast cancer patients who had prior endocrine therapy and chemotherapy. After withdrawing applications in the US and Europe for Datroway in an all-comer metastatic NSCLC indication, AstraZeneca and Daiichi Sankyo now plan to seek approval for the drug in previously treated EGFR-mutant metastatic, nonsquamous NSCLC.