Therapy Areas
Enhertu Significantly Delayed Disease Progression in DESTINY-Breast02 Phase 3 Trial Versus Physician's Choice of Treatment in Patients with HER2 Positive Metastatic Breast Cancer
16 August 2022 - - Positive topline results from the DESTINY-Breast02 phase 3 trial of Enhertu (trastuzumab deruxtecan) versus physician's choice of treatment showed the trial met the primary endpoint, demonstrating a statistically significant and clinically meaningful improvement in progression-free survival in patients with HER2 positive unresectable and/or metastatic breast cancer previously treated with trastuzumab emtansine (T-DM1), Daiichi Sankyo (TSX: 4568) and AstraZeneca (NASDAQ: AZN) said.

The trial also met the key secondary endpoint of improved overall survival.

Enhertu is a specifically engineered HER2 directed antibody drug conjugate being jointly developed and commercialized by Daiichi Sankyo (TSX: 4568) and AstraZeneca (NASDAQ: AZN).

The trial evaluated a similar later-line patient population as the single-arm DESTINY-Breast01 phase 2 trial, which is the basis for initial approvals in advanced HER2 positive metastatic breast cancer.

The safety profile of Enhertu was consistent with previous phase 3 clinical trials with no new safety concerns identified. Interstitial lung disease rates and severity were consistent with those observed in other metastatic breast cancer trials Enhertu with a low rate of grade 5 ILD observed as determined by an independent adjudication committee.

DESTINY-Breast02 is a global, randomized, open-label, pivotal phase 3 trial evaluating the efficacy and safety of Enhertu (5.4 mg/kg) versus physician's choice of treatment (trastuzumab/capecitabine or lapatinib/capecitabine) in patients with HER2 positive unresectable and/or metastatic breast cancer previously treated with T-DM1.

Patients were randomized 2: 1 to receive either Enhertu or physician's choice of treatment.
The primary endpoint of DESTINY-Breast02 is PFS based on blinded independent central review.

The key secondary endpoint is overall survival. Other secondary endpoints include objective response rate based on BICR and investigator assessment, duration of response based on BICR, PFS based on investigator assessment and safety.

DESTINY-Breast02 enrolled approximately 600 patients at multiple sites in Asia, Europe, North America, Oceania and South America.
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