AstraZeneca Plc (LON:AZN), a global, science-led biopharmaceutical company, reported on Monday positive progression-free survival (PFS) results for Imfinzi(durvalumab) and tremelimumab, an anti-CTLA4 antibody, when added to chemotherapy, from the phase III POSEIDON trial in previously-untreated stage IV (metastatic) non-small cell lung cancer (NSCLC).
Reportedly, this 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 versus chemotherapy alone.
Also, the triple combination of Imfinzi plus tremelimumab and chemotherapy demonstrated a statistically significant and clinically meaningful PFS improvement versus 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.
Astrzeneca added that the POSEIDON trial will continue to assess the additional primary endpoint of overall survival (OS) with data anticipated in 2020. AstraZeneca 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 programme in lung cancer. Imfinzi is approved in the curative-intent setting of unresectable, stage III NSCLC after chemoradiation therapy in 53 countries, including the US, Japan and across the EU, based on the phase III PACIFIC trial. Imfinzi is also approved for previously-treated patients with advanced bladder cancer in 11 countries, including the US.
The POSEIDON trial is being conducted in 153 centres across 18 countries, including the US, Europe, South America, Asia and South Africa. Primary endpoints include PFS and OS for the Imfinzi plus chemotherapy arm. Key secondary endpoints include PFS and OS in the Imfinzi plus tremelimumab and chemotherapy arm.
AstraZeneca is focused on the discovery, development and commercialisation of prescription medicines, primarily for the treatment of diseases in the three therapy areas of Oncology, Cardiovascular, Renal and Metabolism and Respiratory.
MedHub-AI's AutocathFFR receives national reimbursement approval in Japan
Early, Evidence-Led Cardiovascular Care Strengthened in High-Risk MENA Regions
Corstasis and U.S. Heart and Vascular partner to advance heart failure care with ENBUMYST
Eli Lilly and Company's orforglipron outperforms oral semaglutide in Phase 3 ACHIEVE-3 trial
Merck reports positive Phase 3 results for oral PCSK9 inhibitor enlicitide
Abbott's Navitor TAVI system granted CE Mark for expanded indication
Cereno Scientific receives FDA Fast Track designation for CS1 in pulmonary arterial hypertension
FDA lifts clinical hold on Rocket Pharmaceuticals' RP-A501 Phase 2 Danon disease trial
OptiBiotix signs distribution deal with major weight management company
Novartis to present cardiovascular abstracts portfolio data at ESC Congress in Madrid
LivaNova announces commercial launch of Essenz Perfusion System in China
Viatris' generic iron sucrose injection gains US FDA approval
CorMedix to acquire Melinta Therapeutics in USD300m deal to expand infectious disease portfolio