AstraZeneca and Daiichi Sankyo Company, Limited's (Daiichi Sankyo) ENHERTU (fam-trastuzumab deruxtecan-nxki) has been granted Breakthrough Therapy Designation (BTD) in the US for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have a HER2 mutation and with disease progression on or after platinum-based therapy.

NSCLC is the most common type of lung cancer, and prognosis is particularly poor for patients with metastatic disease as only about 6-10% will be alive five years after diagnosis. Approximately 2-4% of patients with NSCLC have a HER2 mutation.

The 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 early clinical results that demonstrate substantial improvement on a clinically significant endpoint over available medicines.

Jose Baselga, Executive Vice President, R&D Oncology, 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. Targeted treatments and immunotherapies are demonstrating tremendous advancements, but there remains an unmet medical need for patients with HER2 mutations who are not benefiting from such therapies or for those whose cancer continues to progress.'

Gilles Gallant, Senior Vice President, Global Head, Oncology Development, Oncology R&D, Daiichi Sankyo, said: 'We are encouraged by the promising evidence of activity seen with ENHERTU in patients with advanced lung cancer and a HER2 mutation. We look forward to working closely with the FDA on the potential for ENHERTU to become the first HER2-directed therapy approved for non-small cell lung cancer.'

The FDA granted BTD based on data from the ongoing Phase II DESTINY-Lung01 trial currently testing ENHERTU, a HER2-directed antibody drug conjugate (ADC), in patients with HER2-mutant (HER2m) metastatic NSCLC, and data from the Phase I trial published in Cancer Discovery.

An interim analysis from DESTINY-Lung01will be presented during the 2020 American Society of Clinical Oncology (ASCO20) Virtual Scientific Program, May 29-31, 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 U.S. Last week, ENHERTU received BTD in patients with HER2-positive unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma who have received two or more prior regimens including trastuzumab.

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.

About AstraZeneca in Oncology

AstraZeneca has a deep-rooted heritage in Oncology and offers a quickly-growing portfolio of new medicines that has the potential to transform patients' lives and the Company's future. With at least six new medicines to be launched between 2014 and 2020, and a broad pipeline of small molecules and biologics in development, we are committed to advance Oncology as a key growth driver for AstraZeneca focused on lung, ovarian, breast and blood cancers. In addition to our core capabilities, we actively pursue innovative partnerships and investments that accelerate the delivery of our strategy, as illustrated by our investment in Acerta Pharma in hematology.

By harnessing the power of four scientific platforms Immuno-Oncology, Tumor Drivers and Resistance, DNA Damage Response and Antibody Drug Conjugates and by championing the development of personalized combinations, AstraZeneca has the vision to redefine cancer treatment and one day eliminate cancer as a cause of death.

About AstraZeneca

AstraZeneca is a global, science-led biopharmaceutical company that focuses on the discovery, development and commercialization of prescription medicines, primarily for the treatment of diseases in three main therapy areas - Oncology, Cardiovascular, Renal & Metabolism and Respiratory and Immunology. The Company also is selectively active in the areas of autoimmunity, neuroscience and infection. AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide.

Contact:

Tel: +1 302 885 2677

(C) 2020 Electronic News Publishing, source ENP Newswire