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POSEIDON Reaps Success for Imfinzi in Non-Small Cell Lung Cancer from AstraZeneca, GlobalData says

Non-small-cell lung carcinoma (NSCLC) is an important area for the development and marketing of immuno-oncology (IO) drugs for most large pharmaceutical companies in space, both as monotherapy and in conjunction with other IO agents. The market and use of IO therapies in NSCLC for targeted therapies and chemotherapies is expected to continue to grow, and IO therapies will account for more than 50%. 

Tajekesa Chapman, Senior Oncology and Hematology Analyst at GlobalData, comments: "AstraZeneca recently announced that its combination of Imfinzi (durvalumab) + chemotherapy, with or without tremelimumab, met its key endpoint of improving progression-free survival (PFS) when compared to the standard of care, platinum-based chemotherapy alone, in the Phase III POSEIDON trial. The trial investigated the triplet combination as a first-line treatment in previously untreated patients with non-squamous and squamous stage IV (metastatic) NSCLC, as well as the full range of programmed death-ligand 1 (PD-L1) expression levels, but without epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) mutations.

"The trial will continue to assess the additional primary endpoint of overall survival (OS), with data anticipated in 2020. With no further trial details released at present, AstraZeneca plans to present the results at a forthcoming medical meeting, as well as sharing the results with regulators."

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NSCLC accounts for approximately 85% of lung cancers and has a poor prognosis, with a five-year survival rate as low as 6% for patients with metastatic disease. One of the main unmet needs in NSCLC treatment is the need for more effective first-line treatment options that provide OS benefits to patients with no actionable mutations.

Chapman continued: "Imfinzi and the experimental candidate tremelimumab are monoclonal antibodies (mAbs) classified as IO treatments as they target PD-L1 and cytotoxic T-lymphocyte-associated protein 4 (CTLA-4) proteins on tumor cells, which respectively contribute to T-cell activation and boosting the body"™s immune response against cancer.

"The promise of IO therapies as life-changing cancer treatments for NSCLC was realized with the approval of Bristol-Myers Squibb"™s Opdivo (nivolumab) and Merck & Co"™s Keytruda (pembrolizumab) in 2015, Roche"™s Tecentriq (atezolizumab) in 2016, and Imfinzi in 2018."

Previous failures in the Phase III NEPTUNE and MYSTIC trials lowered expectations of success for the Imfinzi and tremelimumab combination in the treatment of metastatic NSCLC. However, the odds seem to have changed.

Chapman concluded: "There is a lingering amount of skepticism as to whether the more costly and potentially more toxic three-drug regimen of Imfinzi + chemotherapy + tremelimumab will succeed as a first choice treatment for prescribers, even considering the added clinical benefit. AstraZeneca seems to be covering all possible bases and is also trialling Imfinzi as a monotherapy in the Phase III PEARL study, and in various other drug combinations in order to assess its effectiveness in metastatic NSCLC."

*8MM: US, France, Germany, Italy, Spain, the UK, Japan and China

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