The FDA has approved Gilead’s anti-TROP-2 antibody-drug conjugate Trodelvy as a frontline treatment option for two specific triple-negative breast cancer indications, according to a June 25 announcement. With these approvals, Trodelvy is now available as a monotherapy for patients with unresectable locally advanced or metastatic triple-negative breast cancer who are ineligible for PD-1 or PD-L1 therapies. Additionally, the drug can be used in combination with Merck’s Keytruda or Keytruda Qlex to treat triple-negative breast cancer patients whose tumors express PD-L1.
Gilead Chief Medical Officer Dietmar Berger said in the company statement announcing the approval, “For more than twenty years, patients with mTNBC have had limited choices in first-line treatment.” Berger added that by expanding into this setting, Trodelvy “provides a new standard of care for the most aggressive form of breast cancer.”
The FDA approvals were supported by data from the Phase 3 ASCENT-03 and ASCENT-04 studies. In ASCENT-03, treatment with Trodelvy resulted in median progression-free survival of 9.7 months compared to 6.9 months in controls receiving standard anti-cancer regimens—a reduction of 38% in the risk of death or disease progression. The confirmed objective response rate was reported at 50% for those receiving Trodelvy versus 47% among controls.
ASCENT-04 enrolled nearly 450 patients who were randomly assigned to receive either a regimen of Trodelvy and Keytruda or standard chemotherapy. Patients treated with the Merck/Gilead combination experienced median progression-free survival of 11.2 months versus 7.8 months among controls, corresponding to a 35% decrease in risk of death or disease progression.
This approval follows recent developments where Merck and Gilead discontinued their Phase 3 KEYNOTE-D46 study evaluating their combination therapy for non-small cell lung cancer, after an independent data committee found it would be unlikely to meet its primary efficacy goal.
