NSCLC is the most common type of lung cancer, and prognosis is particularly poor for patients with metastatic disease as only about six to 10 percent will be alive five years after diagnosis.[1],[2] Approximately two to four percent of patients with NSCLC have a HER2 mutation.[3],[4]
The
'We are encouraged by the promising evidence of activity seen with ENHERTU in patients with advanced lung cancer and a HER2 mutation,' said
'Today's news is very welcome as we continue to evaluate the potential of ENHERTU to help patients with this devastating type of lung cancer,' said
The FDA granted BTD based on data from ongoing phase 2 DESTINY-Lung01 trial currently assessing ENHERTU, a HER2 directed antibody drug conjugate (ADC), in patients with HER2 mutant metastatic NSCLC and data from the phase 1 trial published in Cancer Discovery. An interim analysis from DESTINY-Lung01 will be presented at the 2020
The overall safety and tolerability profile of ENHERTU in the ongoing DESTINY-Lung01 trial is consistent with that seen in the phase 1 trial. The most common adverse events to date (n=42) are gastrointestinal and hematological including nausea, alopecia, anemia, decreased appetite and decreased neutrophil count. There have been five cases of drug-related interstitial lung disease (ILD) and pneumonitis in patients with HER2 mutant NSCLC, all of which were grade 2. There have been no ILD-related deaths.
This is the third BTD granted for ENHERTU in the
ENHERTU recently received accelerated approval in the
About HER2
HER2 is a tyrosine kinase receptor growth-promoting protein expressed on the surface of many types of tumors including gastric, breast and lung cancers. In some tumors, HER2 overexpression is associated with a specific HER2 gene alteration known as amplification and is often associated with aggressive disease and poorer prognosis.[5]
Other HER2 gene alterations (called HER2 mutations) have been identified in NSCLC, specifically adenocarcinomas, as distinct molecular targets.4,[6]Approximately two to four percent of patients with NSCLC have HER2 mutations, which have been independently associated with cancer cell growth and poor prognosis.3,4
About Non-Small Cell
Lung cancer is the leading cause of cancer death among both men and women and accounts for about one-fifth of all cancer deaths.[7] In the
NSCLC accounts for approximately 80 to 85 percent of all lung cancers.[9] For patients with metastatic disease, prognosis is particularly poor, as only six to 10 percent will be alive five years after diagnosis.1 The introduction of targeted therapies and checkpoint inhibitors in recent years has improved the treatment landscape for patients with advanced NSCLC; however, new approaches are needed for those who are not eligible for available treatments, or whose cancer continues to progress.[10] Currently, no medicine is specifically approved for patients with HER2 mutant NSCLC.
About DESTINY-Lung01
DESTINY-Lung01 is a global, phase 2, open-label, multicenter, two-cohort study evaluating the safety and efficacy of ENHERTU in 170 patients with HER2 mutant (n=90) or HER2 overexpressing (defined as IHC 3+ or IHC 2+, n=80) unresectable and metastatic non-squamous NSCLC whose cancer has progressed after one or more systemic therapies including chemotherapy, molecular targeted therapy or immunotherapy. The primary endpoint is objective response rate (ORR). Key secondary endpoints include duration of response, disease control rate, progression free survival, and overall survival.
About ENHERTU
ENHERTU (fam-trastuzumab deruxtecan-nxki in the
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 has been approved for use only in the
About the ENHERTU Clinical Development Program
A comprehensive development program for ENHERTU is underway globally with six pivotal trials evaluating the efficacy and safety of ENHERTU monotherapy across multiple HER2 cancers including breast, gastric and lung cancers. Trials in combination with other anticancer treatments, such as immunotherapy, also are underway.
About the Collaboration between
In
About
Contact:
Tel: +1 908 992 6631
Email: jbrennan2@dsi.com
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