# AstraZeneca DESTINY-Breast02 Phase III  trial of Enhertu met the primary endpoint

- Link: https://www.directorstalkinterviews.com/astrazeneca-destiny-breast02-phase-iii-trial-of-enhertu-met-the-primary-endpoint/4121077526
- Published: 2022-08-15T07:36:17+01:00
- Author: Amilia Stone

**[AstraZeneca plc](https://www.directorstalkinterviews.com/ftse-company/astrazeneca/azn.l)**(
[LON:AZN](https://www.directorstalkinterviews.com/ftse-company/astrazeneca/azn.l))
has announced that positive high-level results from the DESTINY-Breast02 Phase III
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 (PFS) in patients
with HER2-positive unresectable and/or metastatic breast cancer previously treated
with trastuzumab emtansine (T-DM1). The trial also met the key secondary endpoint
of improved overall survival (OS).

_Enhertu_ is a specifically engineered HER2-directed antibody drug conjugate (ADC)
being jointly developed and commercialised by AstraZeneca and Daiichi Sankyo.

The trial evaluated a similar later-line patient population as the single-arm DESTINY-
Breast01 Phase II trial, which was the basis for initial approvals in advanced HER2-
positive metastatic breast cancer. The safety profile of _Enhertu_ in DESTINY-Breast02
was consistent with previous Phase III clinical trials with no new safety concerns
identified. Interstitial lung disease (ILD) rates and severity were consistent with
those observed in other metastatic breast cancer trials of _Enhertu,_ with a low
rate of Grade 5 ILD events observed as determined by an independent adjudication
committee.

> **Susan Galbraith, Executive Vice President, Oncology R&D, AstraZeneca, said**,“
> 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 programme in HER2-positive metastatic
> breast cancer. These data further strengthen our confidence in _Enhertu_ and reinforce
> its potential to transform patient outcomes across multiple treatment settings.”

> **Ken Takeshita, Global Head, R&D, Daiichi Sankyo, said**: “The top-line results
> from DESTINY-Breast02 confirm the robust progression-free survival seen in previous
> trials of _Enhertu_ and enrich our clinical understanding of the benefit this 
> therapy may offer patients with HER2-positive metastatic breast cancer. As this
> is the confirmatory trial for our current breast cancer indication in Europe and
> several other countries, we look forward to sharing these findings with regulatory
> authorities to add to the body of data for _Enhertu_ for the treatment of HER2-
> positive metastatic breast cancer.”

The data will be presented at a forthcoming medical meeting.

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