While ESMO 2023 is just about to begin, the leading brands in the Pharma industry including AstraZeneca, Daiichi Sankyo, Bayer, etc. are all geared up for this conference to present the respective data readouts. These key market players are quite enthusiastic about this indication for treatment. The hype for the session is the primary results of ENHERTU from DESTINY-PanTumor02 and DESTINY-Lung02 clinical trials.

HER2 NSCLC Highlights

• Abstract Number – #LBA34

• Abstract Type – Mini oral session 
• Indication – NSCLC
• Technology – Dxd ADC Technology

Title: AstraZeneca to present primary results from DESTINY-PanTumor02 Phase II trial in previously treated patients with HER2-expressing or HER2-mutated advanced solid tumours, respectively, who currently have no targeted treatment options

Executive Summary – Recent findings from the Phase II trial, DESTINY-PanTumor02 are set to highlight the promising prospects of ENHERTU in addressing the needs of patients with advanced solid tumors expressing HER2 or bearing HER2 mutations. This trials aim to provide hope for individuals who have no targeted treatment options.

Main Content – A late-breaking mini-oral presentation of primary results from DESTINY-PanTumor02 will highlight efficacy and safety outcomes for ENHERTU in patients with HER2-expressing solid tumours. In July, high-level primary analysis results showed ENHERTU demonstrated clinically meaningful PFS and OS, as well as provided robust and durable tumour responses across multiple HER2-expressing solid tumours in the trial. Additionally, a poster presentation will share exploratory biomarker analyses of HER2 expression and gene amplification in tissue and baseline plasma ctDNA.

• Abstract Number – #1321MO

• Abstract Type – Mini oral session
• Indication – NSCLC
• Technology – Dxd ADC Technology

Title – Daiichi Sankyo will present post-hoc pooled efficacy and safety analyses of the DESTINY-Lung01 and DESTINY-Lung02 Phase II trials of ENHERTU in patients with HER2-mutated metastatic NSCLC with and without brain metastases

Executive Summary - Results from the primary analysis of the DESTINY-Lung02 Phase II trial showed ENHERTU continued to demonstrate strong and durable tumour responses in previously treated patients with HER2-mutant (HER2m) unresectable and/or metastatic non-squamous NSCLC.

Main Content - DESTINY-Lung02 is a global, randomised Phase II trial evaluating the safety and efficacy of ENHERTU in patients with HER2m unresectable and/or metastatic NSCLC with disease recurrence or progression during or after at least one regimen of prior anticancer therapy that must have contained a platinum-based chemotherapy.

AstraZeneca and Daiichi Sankyo’s ENHERTU showed objective response rates of 49% and 56% with 5.4mg/kg and 6.4mg/kg doses respectively in primary analysis. Favourable safety profile confirms 5.4mg/kg as optimal dose in this tumour type and reinforces role of ENHERTU in this setting. The safety profile for both doses was consistent with the overall safety profile of ENHERTU, with the 5.4mg/kg dose demonstrating a favourable safety profile in this patient population.

These promising results demonstrated the potential role of Enhertu to treat the patients suffering from such hard to treat disease. The Drug is expected to generate a market of approximately USD 800 million by 2032 in the 7MM with almost 80% of the market share. The majority of the revenue is estimated to be contributed from second line settting.

 

Note: The therapeutics segment is experiencing significant NSCLC clinical trial activity, which is further expected to drive Non-Small Cell Lung Caner market growth in the coming years.