AstraZeneca announced final overall survival (OS) results from the Phase III NEPTUNE trial, which evaluated Imfinzi (durvalumab) in combination with tremelimumab, an anti-CTLA4 antibody, versus standard-of-care (SoC) platinum-based chemotherapy in previously-untreated Stage IV (metastatic) non-small cell lung cancer (NSCLC) patients.
The trial was performed in an all-comers population, and the primary analysis population was patients with a high tumor mutational burden (TMB). TMB is a measurement of the number of mutations within the genome (DNA) of a tumor, and tumors with high levels of TMB may be more visible to the immune system. In the primary analysis population of patients whose blood TMB was 20 or more mutations per megabase (mut/Mb), the combination of Imfinzi and tremelimumab did not meet the primary endpoint of improving OS compared to SoC chemotherapy. The safety and tolerability profile for the combination of Imfinzi and tremelimumab was consistent with previous trials.
AstraZeneca plans to submit the full results for presentation at an upcoming medical meeting.
About Stage IV NSCLC
Lung cancer is the leading cause of cancer death among both men and women and accounts for about one-fifth of all cancer deaths. Lung cancer is broadly split into NSCLC and SCLC, with 80-85% classified as NSCLC.4 Stage IV is the most advanced form of lung cancer and is often referred to as metastatic disease. Lung cancer patients are most commonly diagnosed after the tumor has spread outside of the lung. For these patients with metastatic disease, prognosis is particularly poor, as only 1 in 10 will be alive five years after diagnosis.
Imfinzi (durvalumab) is a human monoclonal antibody that binds to PD-L1 and blocks the interaction of PD-L1 with PD-1 and CD80, countering the tumor’s immune-evading tactics and releasing the inhibition of immune responses.
Imfinzi is approved for unresectable, Stage III NSCLC in 49 countries including the US, Japan, and across the EU. Imfinzi is also approved for previously-treated patients with advanced bladder cancer in the US, Canada, Brazil, Australia, Israel, India, United Arab Emirates, Qatar, Macau, and Hong Kong.