AstraZeneca Announces Positive Phase III POSEIDON Trial Results for Imfinzi-Based Combination Therapies in First-Line Stage IV NSCLC

Today, AstraZeneca announced that its combination therapy consisting of the PD-L1 monoclonal antibody Imfinzi (durvalumab) and chemotherapy, as well as the triple-combination therapy with the addition of the anti-CTLA-4 antibody tremelimumab, met the primary and key secondary endpoints in the Phase 3 POSEIDON clinical trial for the first-line treatment of patients with stage IV non-small cell lung cancer (NSCLC). Compared with chemotherapy alone, both combination therapies demonstrated statistically significant and clinically meaningful improvements in progression-free survival (PFS).

Lung cancer is the leading cause of cancer-related deaths both worldwide and in China. Each year, more than 780,000 people are diagnosed with lung cancer in China, and over 620,000 die from it. Lung cancer can be broadly classified into small cell lung cancer (SCLC) and non-small cell lung cancer (NSCLC), with NSCLC being the most common type, accounting for 80%–85% of all lung cancer cases. Among patients with NSCLC, 25%–30% have squamous NSCLC, while 70%–75% have non-squamous NSCLC. Most NSCLC patients are diagnosed at an advanced stage, with a five-year survival rate of only 10%.

Imfinzi is a humanized PD-L1 monoclonal antibody that binds to PD-L1 and blocks its interaction with the PD-1 and CD80 receptors, thereby inhibiting the immunosuppressive effects of PD-L1. Imfinzi has received FDA approval for the treatment of patients with previously treated advanced bladder cancer and patients with previously treated stage III unresectable non-small cell lung cancer (NSCLC).

The POSEIDON trial is a randomized, international, multicenter Phase 3 clinical trial. The patient population included individuals with metastatic non-small cell lung cancer (NSCLC), both squamous and non-squamous histologies, who expressed PD-L1 and did not harbor EGFR or ALK gene mutations. The primary endpoints of the trial were progression-free survival (PFS) and overall survival (OS) in NSCLC patients treated with Imfinzi in combination with chemotherapy. Key secondary endpoints included PFS and OS in NSCLC patients treated with the triple therapy regimen of Imfinzi plus tremelimumab and chemotherapy. The results demonstrated that, compared with chemotherapy alone, both the Imfinzi plus chemotherapy combination and the triple therapy adding tremelimumab significantly improved PFS, thereby meeting the primary and key secondary endpoints of the trial. Detailed data from this trial will be presented at future medical conferences.

“The data from the POSEIDON trial demonstrate the efficacy of Imfinzi in treating patients with stage IV NSCLC,” said Dr. José Baselga, Executive Vice President and Head of Oncology R&D at AstraZeneca. “The addition of tremelimumab to the combination of Imfinzi and chemotherapy has a favorable safety profile, and this triplet regimen has the potential to become an important treatment option.”

References:

[1] Imfinzi and Imfinzi plus tremelimumab delayed disease progression in Phase III POSEIDON trial for 1st-line treatment of Stage IV non-small cell lung cancer, Retrieved October 28, 2019, from https://www.astrazeneca.com/content/astraz/media-centre/press-releases/2019/imfinzi-and-imfinzi-plus-tremelimumab-delayed-disease-progression-in-phase-iii-poseidon-trial-for-1st-line-treatment-of-stage-iv-non-small-cell-lung-cancer.html

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