AstraZeneca and Daiichi Sankyo said their TROP2-directed antibody-drug conjugate met a primary survival endpoint in a key subset of patients in a late-stage lung cancer trial, despite a miss in the overall population.
According to new results published Monday, the numerical trend in overall survival favored Dato-DXd, but did not reach statistical significance. However, the prespecified subgroup of patients with nonsquamous disease had a “clinically meaningful” improvement in OS, although specific figures were not disclosed.
Last July, Dato-DXd met the dual primary endpoint of progression-free survival in the registrational TROPION-Lung01 test. But the success was dampened by reports of some patient deaths due to interstitial lung disease, and by the drugmakers having yet to report data from the other primary endpoint of OS.
Jefferies analysts said the survival data in the nonsquamous subset could boost the treatment’s approval prospects. They added that the OS disappointment in the broader population was “expected” and that a US green light could come “well in advance” of the drug’s Dec. 20 PDUFA date.
Dato-DXd is currently under review in the US and EU for the treatment of locally advanced or metastatic nonsquamous non-small cell lung cancer. In February, UBS analysts said the drug could reach $2.5 billion in peak sales.
The Phase 3 study compared Dato-DXd with docetaxel chemotherapy in 600 patients with locally advanced or metastatic NSCLC who had at least one prior line of therapy.
Dato-DXd’s new safety data were consistent with previous results, with no further cases of treatment-related ILD reported. AstraZeneca said the latest results will be presented at an upcoming medical meeting.
The ADC is being studied as a single agent and in combination regimens as part of AstraZeneca’s TROPION development program, which comprises 17 studies covering NSCLC, triple-negative breast cancer and HR-positive, HER2-negative breast cancer. The drug met the PFS primary endpoint versus chemotherapy in a Phase 3 test in certain breast cancer patients in September.
Editor’s Note: This article has been corrected to note that OS and PFS are dual primary endpoints, not co-primary endpoints; the date of data of publication; and the number of trials in the TROPION program.