AstraZeneca,Daiichi Sankyo Continue Earlier-Line Breast Cancer Push with Phase III Enhertu Win

AstraZeneca's San Francisco Office

Pictured:AstraZeneca's office in South San Francisco,California/iStock,hapabapa

AstraZenecaand,andDaiichi Sankyoon Monday可回收topline findingsfrom the Phase III DESTINY-Breast06study,showing that their antibody-drug conjugate Enhertu(trastuzumab-deruxtecan)yielded significant survival benefits in certain patients with metatic breast cancer。

With more than860 patients enrolled,DESTINY-Breast06pit Enhertu against an investigator’s choice of chemotherapy,including capecitabine,paclitaxel or nab-paclitaxel。Only patients who were HR positive and with low or ultralow expression levels of the HER2 protein were eligible for enrollment。All study participants had also undergone at least one prior line of endocrine therapy。

Topline results showed that Enhertu treatment led to a“statistically significant and clinically meaningful improvement”in progression-free survival(PFS)。This effect remained consistent when focusing specifically on patients with low or ultralow HER2expression。

However,overall survival(OS)data were not yet mature at the time of the interim analysis。Still,DESTINY-Breast06detected“an early trend towards an OS improvement versus standard of care chemotherapy”in the overall study population and particularly in the subgroup of patients with low HER2expression,according to the companies。

DESTINY-Breast06will continue as planned to evaluate OS and other secondary endpoints。

Susan Galbraith,executive vice president of oncology R&at AstraZeneca,ina statement said that Monday’s readout readforces that Enhertu“could become a new standard of care”for HER2low and HER2 ultralow metatic breast cancer,followat least one of endocrine treatment。

“These data underscore the potential for treatment with Enhertu across the spectrum of HR-positive breast cancer,further redefining the treatment of metastatic breast cancer,”Galbraith added。

AstraZeneca and Daiichi Sankyo didnot reveal specific data in Monday’s announcement but promised to do so at an upcoming medical congress。The partners will also share their findings to global regulatory authorities,with an eye toward label expansion。

Designed using Daiichi Sankyo’s DXd antibody-drug conjugate(ADC)platform,Enhertutargets the HER2protein,which is involved in the hyperactive growth and division of cancer cells。It carries a number of topoisomerase I inhibitor payloads,which triggers cell death。The ADCfirst won the FDA’s approval in December2019for hard-to-treat HER2-positive breast cancer。

Earlier this month,Enhertubagged the FDA’s first tumor-agnostic ADC approval,opening up its use in patients with HER2-positive solid tumors who had undergone prior systemic treatment and who have no available alternative treatment options。

Tristan Manalac is an independent science writer based in Metro Manila,Philippines。到达,到达LinkedIn过热器,过热器tristan@tristanmanalac.com或,或tristan.manalac@biospace.com

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