AstraZeneca Plc (LON:AZN), a global, science-led biopharmaceutical company, along with MedImmune, its global biologics research and development arm, announced on Friday overall survival (OS) results for the phase III EAGLE trial.
EAGLE is a randomised, open-label, multi-centre trial evaluating Imfinzi (durvalumab) monotherapy or Imfinzi in combination with tremelimumab, an anti-CTLA4 antibody, versus standard-of-care (SoC) chemotherapy in patients with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) who experienced disease progression following platinum -based chemotherapy, regardless of their PD-L1 tumour status.
This trial was conducted at 169 centres across 24 countries including the US, Europe, South America, Japan, Korea, Taiwan, Israel and Australia. The primary endpoint of the trial was OS, while secondary endpoints included progression-free survival, landmark OS, objective response rate and duration of response.
Reportedly, Imfinzi monotherapy and the combination of Imfinzi plus tremelimumab did not meet the primary endpoints of improving OS compared to SoC chemotherapy in these hard-to-treat patients. The safety and tolerability profiles for Imfinzi and the combination with tremelimumab were consistent with previous experience.
According to the company, while these results are disappointing, it remains committed to evaluating the potential of Imfinzi and other innovative medicines for patients with head and neck cancer.
The company added that it is looking forward to seeing the results of the phase III KESTREL trial of Imfinzi and tremelimumab in patients who have not received prior chemotherapy for recurrent or metastatic head and neck squamous cell carcinoma in H1 2019.
AstraZeneca will submit the results from the phase III EAGLE trial for presentation at a forthcoming medical meeting.
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 & Metabolism and Respiratory.
Revier Therapeutics closes EUR6m seed financing and launches operations
Tempus announces receipt of FDA clearance for AI pulmonary hypertension detection product
European Commission grants orphan designation for Lundbeck's asedebart
Hanmi Pharm enters exclusive licensing deal with Genentech for obesity therapy HM17321
Olio Labs reveals study demonstrating AI-driven in vivo platform can predict clinical trial outcomes
Mezzion Pharma Co reports positive results from new in vivo study of udenafil
Incyte's Opzelura approved in European Union for moderate atopic dermatitis
American Regent recalls one lot of Papaverine Hydrochloride Injection due to particulate matter
Galmed announces breakthrough development of SCD1 inhibitor Aramchol for cardiac fibrosis
EQT to acquire biosurgery company Corza Biosurgery
Cirius Therapeutics commences enrolment and dosing for Phase 2 study of CIR-0602K in type 1 diabetes
Thalia Therapeutics acquires Sanmirna and raises GBP2.75m to advance AML RNA therapy