AstraZeneca announced Monday that Imfinzi (durvalumab) and IMFINZI Plus Tremelimumab Delayed Disease Progression in Phase III POSEIDON Trial for 1st-Line Treatment of Stage IV Non-Small Cell Lung Cancer.
WILMINGTON, Del.–(BUSINESS WIRE)–AstraZeneca today announced positive progression-free survival (PFS) results for IMFINZI and tremelimumab, an anti-CTLA-4 antibody, when added to chemotherapy, from the Phase III POSEIDON trial in previously-untreated Stage IV (metastatic) non-small cell lung cancer (NSCLC).
The trial met a primary endpoint by showing a statistically significant and clinically meaningful improvement in the final PFS analysis in patients treated with the combination of IMFINZI and a broad choice of five standard-of-care platinum-based chemotherapy options vs. chemotherapy alone. The triple combination of IMFINZI plus tremelimumab – a potential new medicine – and chemotherapy also demonstrated a statistically significant and clinically meaningful PFS improvement vs. chemotherapy alone as a key secondary endpoint. The safety and tolerability of IMFINZI was consistent with its known safety profile. The triple combination delivered a broadly similar safety profile to the IMFINZI and chemotherapy combination and did not result in increased discontinuation of therapy.
José Baselga, Executive Vice President, Oncology R&D, said: “The POSEIDON trial provides evidence of the efficacy of IMFINZI in patients with Stage IV non-small cell lung cancer. Clinical benefit was observed in a trial population that included a high proportion of patients with squamous disease and multiple choices of chemotherapy regimens. Additionally, the potential to add tremelimumab to IMFINZI and chemotherapy may present an important treatment approach in this challenging setting, especially taking into consideration the favorable safety profile.”
In this trial, IMFINZI was given as a fixed dose (1500mg) every 3 weeks in combination with chemotherapy and then every 4 weeks until disease progression. The POSEIDON trial will continue to assess the additional primary endpoint of overall survival (OS) with data anticipated in 2020AstraZeneca will submit the results for presentation at a forthcoming medical meeting and plans to share the results with health authorities.
IMFINZI is also being tested in Stage IV NSCLC as monotherapy in the Phase III PEARL trial, and in earlier stages of disease as part of an extensive Immuno-Oncology program in lung cancer.
IMFINZI is approved in the curative-intent setting of unresectable, Stage III NSCLC after concurrent chemoradiation therapy based on the Phase III PACIFIC trial.