GSK lung cancer drug gets FDA breakthrough designation

Pharmaceutical giant GSK announced on Tuesday that the US Food and Drug Administration (FDA) has granted breakthrough therapy designation to its investigational drug, GSK5764227 (GSK'227), for the treatment of patients with extensive-stage small-cell lung cancer (ES-SCLC) who had experienced disease progression following platinum-based chemotherapy.

The FTSE 100 company said the designation was intended to accelerate the development and review of treatments that could offer substantial improvements over existing options for serious conditions.

It described ES-SCLC as a particularly aggressive and challenging form of lung cancer, with a five-year survival rate of just 3%.

The current standard treatments for patients who relapsed after initial therapy typically resulted in poor outcomes, with a median overall survival of just five to six months.

It said the FDA's decision was based on promising early clinical data from the ongoing ARTEMIS-001 phase one trial, which was evaluating the safety and efficacy of GSK'227 in over 200 patients with various advanced or metastatic solid tumours, including relapsed or refractory ES-SCLC.

GSK acquired the worldwide rights, excluding certain Asian territories, to GSK'227 earlier this year from Hansoh Pharma, which conducted the initial trial.

The company said it planned to advance its global phase one and two trials for GSK'227 in the second half of 2024, with the aim of establishing a registrational pathway for the drug.

Further data from the ARTEMIS-001 trial would meanwhile be presented at the 2024 World Conference on Lung Cancer in September.

“Extensive-stage small-cell lung cancer is aggressive with poor prognosis and significant need for new treatments,” said senior vice-president and global head of oncology research and development Hesham Abdullah.

“Today's breakthrough therapy designation supports our ambition to accelerate GSK'227 for these patients as part of our broader ADC programme focused on developing new treatment options with transformational and first-to-market potential.”

At 0833 BST, shares in GSK were down 0.41% at 1,592.5p.

Reporting by Josh White for Sharecast.com.