Results from one of AstraZeneca’s key lung cancer trials shows that compared to chemotherapy, its experimental precision drug did not significantly improve overall survival results.
The overall survival, or OS rates, in the TROPION-Lung01 trial “did not reach statistical significance in patients whose non-small cell lung cancer had returned after one or two prior treatment attempts,” the company said in a presentation at the World Conference on Lung Cancer last week.
Datopotamab deruxtecan showed median OS of 14.6 months in patients with advanced Non squamous non-small cell lung cancer but still demonstrated potential in neoadjuvant early-stage non-small cell lung cancer.
Dr Jacob Sands, from the Dana-Farber Cancer Institute of Medical Oncology and lead investigator in the trial, said that while immunotherapy and targeted therapies had improved outcomes in the 1st-line metastatic setting, most patients eventually experienced disease progression and needed chemotherapy – despite its limited effectiveness and known side effects.
“Even with the many efforts to surpass docetaxel with novel approaches in previously treated advanced or metastatic non-small cell lung cancer, patients only survive for about one year,” he said.
“However, for datopotamab deruxtecan to show a statistically significant improvement in progression-free survival along with improved response rate, duration of response and an overall survival improvement numerically consistent with progression-free survival is clinically meaningful for patients with nonsquamous lung cancer.”
Datopotamab deruxtecan is a specifically engineered TROP2-directed DXd antibody drug conjugate discovered by Daiichi Sankyo, who entered into a global collaboration with AstraZeneca to jointly develop and commercialise the drug in July 2020.
TROP2 is a protein broadly expressed in most NSCLC tumours and Datopotamab deruxtecan (Dato-DXd) is an investigational TROP2-directed ADC, one of six DXd ADCs in Daiichi Sankyo’s oncology pipeline, and one of the most advanced programmes in AstraZeneca’s ADC scientific platform.
Currently there are no TROP2-directed ADCs approved for the treatment of lung cancer.
“A comprehensive global clinical development programme is underway with more than 20 trials evaluating the efficacy and safety of datopotamab deruxtecan across multiple cancers, including NSCLC, triple-negative breast cancer and HR-positive, HER2-negative breast cancer,” Dr Sands said.
“The program includes seven Phase III trials in lung cancer and five Phase III trials in breast cancer evaluating datopotamab deruxtecan as a monotherapy and in combination with other anticancer treatments in various settings.
“Together with the data we have presented for the potential TROP2-QCS biomarker and from NeoCOAST-2 in early-stage disease, these results underscore our confidence in the important role datopotamab deruxtecan can play across segments and settings of non-small cell lung cancer.”