AstraZeneca's Imfinzi has delivered positive clinical data in another type of lung cancer, building on the immunotherapy’s existing FDA clearance in stage 3 non-small cell lung cancer and extensive-stage small cell lung cancer.
The latest trial win features Imfinzi as a therapy for limited-stage small cell lung cancer (LS-SCLC). Compared with placebo, Imfinzi significantly extended patients’ lives among those who had not progressed following concurrent chemoradiotherapy, AZ said Friday.
Besides hitting the overall survival endpoint, Imfinzi also significantly prolonged the time before tumor progression or death. The positive results came from part of the phase 3 ADRIATIC trial.
Imfinzi is now the first immunotherapy to demonstrate a survival benefit in this LS-SCLC setting in a global phase 3 trial, AZ noted in a release. The tumor subtype makes up about 30% of SCLC cases, with a five-year survival rate currently estimated at around 15% to 30%.
“These exciting results build on the transformative efficacy of Imfinzi in extensive-stage small cell lung cancer and demonstrate the potential to bring a curative-intent immunotherapy treatment to this earlier-stage setting of small cell lung cancer for the first time,” AZ’s oncology R&D chief, Susan Galbraith, Ph.D., said in a statement Friday.
The other part of ADRIATIC—which is studying AZ’s other immunotherapy Imjudo on top of Imfinzi—remains blinded and will continue to the next planned analysis.
Hitting the goal early in a clinical trial is typically an indication of strong and clear efficacy although the magnitude of benefit isn't necessarily weaker for a late readout versus an early one. In addition, the trial follow-up periods may differ between the two experimental arms given enrollment speeds.
AZ has a plan to have more than half of all lung cancer patients eligible for its medicines by 2030. For Imfinzi, the British pharma is pushing the PD-L1 inhibitor as a treatment both before and after surgery in early-stage non-small cell lung cancer (NSCLC). The company is expecting an FDA decision for Imfinzi as a neoadjuvant therapy in the first half of 2024.
AstraZeneca's top-selling oncology product, Tagrisso, recently scored an FDA approval for use alongside chemotherapy to treat patients with newly diagnosed advanced EGFR-mutant NSCLC. In February, the drug also showed a significant progression-free survival benefit as a maintenance therapy in stage 3 EGFR-mutated NSCLC following chemoradiation. And AZ expects results from the NeoADAURA trial for Tagrisso in the neoadjuvant resectable setting in the second half of this year.
In addition, the FDA recently accepted AZ and its partner Daiichi Sankyo’s application for their TROP2 antibody-drug conjugate datopotamab deruxtecan (Dato-DXd) in previously treated nonsquamous NSCLC. However, the drug’s disappointing results in squamous NSCLC were considered a setback.
Enhertu, the other ADC in the AZ-Daiichi partnership, is approved in previously treated HER2-mutant NSCLC. A phase 3 trial coded DESTINY-Lung04 is evaluating the HER2-targeted agent in the first-line setting, with a readout expected in 2025.
Through a collaboration with Hutchmed, AZ also has Orpathys, or savolitinib, which has been approved in China for NSCLC with MET exon 14 skipping alterations.