United Kingdom-based AstraZeneca's lung cancer combo of Imfinzi (durvalumab) plus tremelimumab has failed to deliver desired results in a phase III trial, called ARCTIC, in patients with locally-advanced or metastatic non-small cell lung cancer (NSCLC) who had more than two prior treatments, it was reported yesterday.
This randomised, open-label, multi-centre trial evaluated the efficacy and safety of the combination of Imfinzi (durvalumab) plus tremelimumab, and Imfinzi and tremelimumab monotherapies, versus standard-of-care (SoC) chemotherapy in patients with PDL1-low/negative NSCLC (sub-study B), and Imfinzi monotherapy versus SoC in patients with PDL1-high NSCLC (sub-study A).
In sub-study B, the combination of Imfinzi plus tremelimumab in patients with PD-L1 low/negative NSCLC did not meet the primary endpoints of a statistically-significant and clinically-meaningful improvement in progression-free survival and overall survival compared to SoC. Imfinzi monotherapy showed a clinically-meaningful reduction in the risk of death compared to chemotherapy.
AstraZeneca global medicines development executive vice president and chief medical officer, Sean Bohen, said, 'While we are disappointed that the combination of Imfinzi plus tremelimumab did not result in a statistically-significant survival benefit in this heavily pre-treated patient population, we are encouraged by the activity of Imfinzi monotherapy observed in this trial and look forward to presenting the full data from the ARCTIC trial at an upcoming medical meeting.'
Insmed reports Phase 2b study of brensocatib did not meet efficacy endpoints
Gilead to acquire Tubulis to expand ADC oncology capabilities
FDA grants Fast Track status to SIM0505 for platinum‑resistant ovarian cancer
Sanofi reports positive phase 2 results for lunsekimig in asthma and CRSwNP
Aelis Farma secures EUR458k France 2030 grant to advance metabolic disease programme
Immedica Pharma gains European approval to extend Efmody use in adrenal insufficiency
NeuroSense's PrimeC composition receives Brazilian patent
AstraZeneca reports positive Phase III data for Imfinzi and Imjudo in liver cancer
Thermo Fisher Scientific unveils CHOvantage GS Kit to speed biologics development
Frontier Medicines licenses FMC-220 oncology programme to LG Chem in global deal
NJ Bio and Aji Bio-Pharma partner to strengthen support for ADC development
Alltrna granted approval for first-in-human clinical trial of AP003