AstraZeneca Shares Edged 3.86% Higher, Later Fell – Here’s Why

The AstraZeneca plc (LON: AZN) share price edged 3.86% higher after receiving regulatory approval in the European Union for its groundbreaking drug, Enhertu (trastuzumab deruxtecan), to be used as a monotherapy for the treatment of adult patients with advanced non-small cell lung cancer (NSCLC).

Enhertu was developed jointly by AstraZeneca and Daiichi Sankyo as a treatment for patients whose tumours have an activating HER2 (ERBB2) mutation and who require systemic therapy after receiving platinum-based chemotherapy, with or without immunotherapy.

Enhertu is a unique HER2-directed antibody-drug conjugate (ADC) that results from the collaborative efforts of AstraZeneca and Daiichi Sankyo in its development and commercialisation.

The green light from the European Commission comes following a favourable assessment by the Committee for Medicinal Products for Human Use. The decision is grounded in the compelling results of the DESTINY-Lung02 Phase II trial, presented at the IASLC 2023 World Conference on Lung Cancer and published in the Journal of Clinical Oncology.

The trial outcomes showcased the efficacy of Enhertu at a dose of 5.4mg/kg. The drug demonstrated a confirmed objective response rate (ORR) of 49.0%, as assessed by a blinded independent central review (BICR), in patients who had previously received treatment for advanced or metastatic HER2-mutant (HER2m) NSCLC.

The results included one complete response (CR) amounting to 1.0% and 49 partial responses (PR) at 48.0%. Moreover, the median duration of response (DoR) was an impressive 16.8 months.

This approval is a significant milestone for patients and healthcare providers in the EU, offering a promising treatment option for those with advanced NSCLC characterised by HER2 mutations. Enhertu's efficacy and success in clinical trials demonstrate the power of precision medicine and innovative therapies in the fight against cancer.

Dave Fredrickson, Executive Vice President, Oncology Business Unit, AstraZeneca, said: “Understanding the molecular drivers behind a lung cancer diagnosis is critical, and while there are now targeted options for many patients, those with HER2-mutant non-small cell lung cancer have had few treatment options, none of which have been approved to treat their specific type of lung cancer. Enhertu is the first HER2-directed option approved for HER2-mutant disease and confirms the relevance of HER2 as a target in lung cancer.”

AstraZeneca's share price. 

The AstraZeneca share price edged 3.86% higher to trade at 10841.0p, from Friday’s closing price of 10438.0p, but later fell back.