ENHERTU was granted accelerated approval by the
'Many patients with this aggressive form of metastatic breast cancer continue to face tumor progression despite being treated with two or more HER2 directed treatment regimens,' said
In the single-arm, phase 2 DESTINY-Breast01 trial that included 184 female patients with HER2 positive metastatic breast cancer, ENHERTU (5.4 mg/kg) achieved a confirmed objective response rate of 60.3% (n=111; 95% CI: 52.9-67.4), including a 4.3% complete response rate (n=8) and a 56.0% partial response rate (n=103).[1] The median duration of response was 14.8 months (n=111; 95% CI: 13.8-16.9).
ENHERTU is approved with a Boxed WARNING for Interstitial Lung Disease (ILD)/pneumonitis and Embryo-Fetal Toxicity. The safety of ENHERTU has been evaluated in a pooled analysis of 234 patients with unresectable or metastatic HER2 positive breast cancer who received at least one dose of ENHERTU (5.4 mg/kg) in the DESTINY-Breast01 trial and a phase 1 trial. ILD occurred in 9% of patients. Fatal outcomes due to ILD and/or pneumonitis occurred in six patients (2.6%) - two deaths already reported from the phase 1 trial and four deaths already reported in the phase 2 DESTINY-Breast01 trial. Patients and physicians should be aware of ILD/pneumonitis and patients should be actively monitored for potential signs and symptoms. If ILD/pneumonitis is identified, it should be managed as per the FDA approved Prescribing Information. Management may require dose modification or treatment discontinuation and steroid treatment. ENHERTU can cause fetal harm when administered to a pregnant woman. The most common adverse reactions (frequency 20%) were nausea, fatigue, vomiting, alopecia, constipation, decreased appetite, anemia, neutropenia, diarrhea, leukopenia, cough and thrombocytopenia.
About ENHERTU
ENHERTU (fam-trastuzumab deruxtecan-nxki), formerly known as DS-8201, is the lead product in the ADC Franchise of the Daiichi Sankyo Cancer Enterprise and the most advanced program in AstraZeneca's ADC Scientific platform. ADCs are targeted cancer medicines that deliver cytotoxic chemotherapy ('payload') to cancer cells via a linker attached to a monoclonal antibody that binds to a specific target expressed on cancer cells.
Designed using
ENHERTU received Priority Review, Breakthrough Therapy Designation, and Fast Track Designation from the FDA for the treatment of select patients with HER2 positive metastatic breast cancer.
About the Collaboration between
In
About the Clinical Development Program
A comprehensive development program for fam-trastuzumab deruxtecan-nxki is underway globally with five pivotal trials in HER2 expressing metastatic breast and gastric cancer, including a trial in patients with metastatic breast cancer and low levels of HER2 expression (HER2 low). Phase 2 trials are underway for HER2 expressing advanced colorectal cancer as well as metastatic non-squamous HER2 overexpressing or HER2 mutated non-small cell lung cancer. Trials in combination with other anticancer treatments, such as immunotherapy, also are underway.
A regulatory submission also has been made to
About
Contact:
Tel: +1 908 992 6631
Email: jbrennan2@dsi.com
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