Enhertu extends progression-free survival in breast cancer subgroup, topline data show
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Fam-trastuzumab deruxtecan-nxki conferred a statistically significant and clinically meaningful PFS benefit among patients with unresectable and/or metastatic HER2-positive breast cancer, according to data from the agent’s manufacturer.
Results of the randomized, phase 3 DESTINY-Breast02 trial showed fam-trastuzumab deruxtecan-nxki (Enhertu; AstraZeneca, Daiichi Sankyo) met the primary endpoint of improved PFS vs. physician’s treatment choice specifically among patients who previously received ado-trastuzumab emtansine (Kadcyla, Genentech), also known as T-DM1. The trial also achieved a key secondary endpoint of improved OS.
AstraZeneca and Daiichi Sankyo are jointly developing and commercializing fam-trastuzumab deruxtecan, also known as trastuzumab deruxtecan. The novel antibody-drug conjugate has three components: a humanized anti-HER2 immunoglobulin G1 monoclonal antibody with the same amino acid sequence as trastuzumab (Herceptin, Genentech); a topoisomerase 1 inhibitor payload; and a tetrapeptide-based cleavable linker.
For DESTINY-Breast02, researchers enrolled about 600 patients globally and randomly assigned them in a 2:1 ratio to either 5.4 mg/kg trastuzumab deruxtecan or physician’s choice of capecitabine with trastuzumab or lapatinib (Tykerb, Novartis).
In addition to meeting the trial’s primary endpoint of PFS by blinded independent central review, trastuzumab deruxtecan exhibited a safety profile consistent with previous phase 3 trials, with no new safety concerns, according to an AstraZeneca press release. Rates and severity of interstitial lung disease also appeared similar to other trials of the agent in metastatic breast cancer, including a low rate of grade 5 interstitial lung disease as assessed by an independent adjudication committee.
“The DESTINY-Breast02 trial results in this patient population with advanced disease confirm the efficacy and safety profile seen in DESTINY-Breast01 and are consistent with the results seen across our broader clinical program in HER2-positive metastatic breast cancer,” Susan Galbraith, executive vice president for oncology research and development with AstraZeneca, said in the release. “These data further strengthen our confidence in Enhertu and reinforce its potential to transform patient outcomes across multiple treatment settings.”
Trastuzumab deruxtecan had been approved in the United States for treatment of adults with metastatic HER2-positive breast cancer who received prior anti-HER2-based therapies, as well as adults with HER2-positive advanced gastric or gastroesophageal junction adenocarcinoma who received a prior trastuzumab-based regimen. Last week, the FDA approved the agent for treatment of patients with unresectable or metastatic HER2-low breast cancer who received prior chemotherapy in the metastatic setting or whose disease progressed during or within 6 months of adjuvant chemotherapy. The agency also granted trastuzumab deruxtecan accelerated approval for treatment of certain adults with HER2-mutated unresectable or metastatic non-small cell lung cancer.
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