Daiichi Sankyo and AstraZeneca’s Enhertu trastuzumab has been granted Breakthrough Therapy Designation (BTD) in the U.S. for the treatment of patients with HER2 positive unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma who have received two or more prior regimens including trastuzumab.
TOKYO, BASKING RIDGE, N.J. & MUNICH–(BUSINESS WIRE)–Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) and AstraZeneca’s ENHERTU® (fam-trastuzumab deruxtecan-nxki) has been granted Breakthrough Therapy Designation (BTD) in the U.S. for the treatment of patients with HER2 positive unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma who have received two or more prior regimens including trastuzumab.
Gastric cancer is the third leading cause of cancer mortality with a five-year survival rate of five percent for metastatic disease.1,2 Approximately one in five gastric cancers are considered HER2 positive.3
The U.S. Food and Drug Administration’s (FDA) BTD is designed to accelerate the development and regulatory review of potential new medicines that are intended to treat a serious condition and address a significant unmet medical need. The new medicine needs to have shown encouraging preliminary clinical results that demonstrate substantial improvement on a clinically significant endpoint over available medicines.
“DESTINY-Gastric01 represents the first randomized trial of ENHERTU to demonstrate clinically meaningful and statistically significant results, including objective response and survival increases compared to physician’s choice of chemotherapy,” said Gilles Gallant, BPharm, PhD, FOPQ, Senior Vice President, Global Head, Oncology Development, Oncology R&D, Daiichi Sankyo. “We are thrilled that the FDA has granted ENHERTU a second Breakthrough Therapy Designation.”
“For patients with HER2 positive metastatic gastric cancer, current therapy options are limited, and for those who progress, there no approved HER2 targeted medicines,” said José Baselga, MD, PhD, Executive Vice President, Oncology R&D, AstraZeneca. “We look forward to working with the FDA to further explore the potential of ENHERTU to become an important new treatment and the first antibody drug conjugate for this devastating disease.”
The overall safety and tolerability profile of ENHERTU in DESTINY-Gastric01 was consistent with that seen in the phase 1 trial in which the most common adverse events (≥30 percent, any grade) were hematologic and gastrointestinal including neutrophil count decrease, anemia, nausea and decreased appetite. There were cases of drug-related interstitial lung disease (ILD) and pneumonitis, the majority of which were grade 1 and 2 with two grade 3 and one grade 4. No ILD-related deaths (grade 5) occurred in patients with gastric cancer in the phase 1 trial or in the DESTINY-Gastric01 trial.
The research results of DESTINY-Gastric01 will be presented at the 2020 American Society of Clinical Oncology (ASCO20) Virtual Scientific Program.
ENHERTU received SAKIGAKE designation in March 2018 by Japan’s Ministry of Health, Labour and Welfare (MHLW) for potential use in the same HER2 positive gastric cancer patient population and was recently submitted to the Japan MHLW for approval. This is the second Breakthrough Therapy Designation granted for ENHERTU in the US, and the third expedited regulatory designation received globally.
ENHERTU recently received accelerated approval in the U.S. and approval in Japan under the early conditional approval system for the treatment of adult patients with unresectable or metastatic HER2 positive metastatic breast cancer who have received two or more prior anti-HER2 based regimens.