The National Institute for Health and Care Excellence (NICE) has recommended Enhertu® (trastuzumab deruxtecan) for use within the Cancer Drugs Fund (CDF) as an option for treating HER2 positive unresectable or metastatic breast cancer in adults who have received two or more prior anti-HER2 based therapies.
The recommendation from NICE is based on the results of the single arm, multicentre, open label, phase 2 DESTINY-Breast01 trial of trastuzumab deruxtecan (5.4 mg/kg) in 184 patients with HER2 positive metastatic breast cancer who had received two or more prior anti-HER2-based therapies.
Results from the data cut-off in June 2020 demonstrated a confirmed objective response rate (ORR) of 61.4% (95% CI: 54.0-68.5), including a 6.5% complete response rate and a 54.9% partial response rate. After a median follow-up of 20.5 months, the median duration of response (DoR) was 20.8 months (95% CI: 15.0-NR). Trastuzumab deruxtecan showed a generally tolerable safety profile with 34 (18.5%) treatment discontinuations due to treatment-emergent adverse events.
Professor Peter Schmid, Barts Cancer Institute said: “HER2 positive disease impacts one in five women with breast cancer, yet there is still no clear standard of care for patients with HER2 positive disease who have progressed following first-and second-line therapy. The availability of trastuzumab deruxtecan through NHS England’s Cancer Drugs Fund is good news for patients and brings an important new treatment option to those whose disease has continued to progress despite previous treatment”.
Jo Taylor, founder of METUP UK, an advocacy group for people living with metastatic breast cancer said: “This authorisation is a significant step forward for the many thousands of people in England living with HER2 positive metastatic breast cancer. Disease progression in metastatic breast cancer patients is an unmet need beyond second line treatment and new medicines are essential in the challenge to suppress this incurable disease.”
Haran Maheson, Commercial Director for Oncology, Daiichi Sankyo U.K said: “We are very proud to have worked with NICE, NHS England and the breast cancer community to make trastuzumab deruxtecan available, through the Cancer Drugs Fund, to eligible patient in England with HER2 positive metastatic breast cancer whose disease has progressed following treatment with two anti-HER2 directed therapies”.
Arun Krishna, Head of Oncology, AstraZeneca U.K said: “Though many treatment advances have been made in HER2 positive metastatic breast cancer, there has been no clear standard of care for patients following progression after second line treatment and many patients do not have a durable response to other available later-line options. To know that patients in England now have access to a new treatment option is welcome news indeed”.
 ENHERTU Summary of Product Characteristics. February 2021.
 Modi S et al. Presented at SABCS 2020 Poster PD3-06