The companies’ Biologics License Application for antibody-drug conjugate datopotamab deruxtecan has been accepted by the FDA for locally advanced or metastatic nonsquamous non-small cell lung cancer.
Pictured: Exterior of an FDA building/iStock, Grandbrothers
The FDA has accepted the Biologics License Application for AstraZeneca and Daiichi Sankyo’s antibody-drug conjugate datopotamab deruxtecan for treating adults with locally advanced or metastatic nonsquamous non-small cell lung cancer who have previously received systemic therapy.
The regulator has set a PDUFA date of Dec. 20, 2024 for the antibody-drug conjugate (ADC), known as Dato-DXd, which is being developed by Daiichi Sankyo and AstraZeneca. If approved by the FDA, Dato-DXd may be the first TROP2-directed ADC for patients with lung cancer, according to the companies.
The BLA is based on results from the Phase III Tropion-Lung01 study, which demonstrated that Dato-DXd had a statistically significant primary endpoint of progression-free survival (PFS) compared to the chemotherapy docetaxel. Specifically, the ADC was shown to reduce the risk of disease progression or death by 25% compared to the chemotherapy and netted a p-value of p=0.004. Median PFS was marked at 4.4 months, while the overall response rate was confirmed in 26.4% of patients.
For the other endpoint of overall survival, the interim results “numerically favored” the ADC over docetaxel, but the results did not reach statistical significance by the data cutoff in October 2023.
The trial is ongoing and AstraZeneca and Daiichi Sankyo said there is still a “favorable” trend with overall survival, which will be evaluated in the final analysis.
“Datopotamab deruxtecan has the potential to offer patients with previously treated advanced nonsquamous non-small cell lung cancer an effective and tolerable alternative to conventional chemotherapy,” Susan Galbraith, executive vice president of oncology R&D at AstraZeneca, said in a statement. “With regulatory discussions ongoing around the world and a parallel submission underway in the U.S. in breast cancer, this is only the beginning of our efforts to make this novel treatment available to patients as quickly as possible.”
Both companies are also expecting another BLA for the ADC for HER2-negative breast cancer but said that it is pending acceptance. There are also other regulatory submissions for the drug in other lung and breast cancer indications as well.
In January 2024, the companies’ ADC Enhertu was given priority review for a supplemental BLA for the treatment of adults with unresectable or metastatic HER2 positive solid tumors, who have received prior treatment or who have no satisfactory alternative treatment options.
Tyler Patchen is a staff writer at BioSpace. You can reach him at tyler.patchen@biospace.com. Follow him on LinkedIn.
