Policy & Regulation
AstraZeneca reports detailed result of phase III CASPIAN trail for Imfinzi in extensive-stage small cell lung cancer
10 September 2019 -

AstraZeneca Plc (LON:AZN), a global, science-led biopharmaceutical company, on Monday presented detailed results from the phase III CASPIAN trial, showing that Imfinzi (durvalumab) significantly improved overall survival (OS) in patients with previously-untreated extensive-stage small cell lung cancer (SCLC).

This CASPIAN trial is a randomised, open-label, multi-centre, global, phase III trial in the 1st-line treatment of patients with extensive-stage SCLC.

According to AstraZeneca, Imfinzi in combination with four cycles of standard-of-care (SoC) chemotherapy (etoposide with either cisplatin or carboplatin) demonstrated a statistically-significant and clinically-meaningful improvement in OS vs. SoC consisting of up to six cycles of chemotherapy and optional prophylactic cranial irradiation (PCI).

Also, the risk of death was reduced by 27% (equal to a hazard ratio of 0.73), with median OS of 13.0 months for Imfinzi plus chemotherapy vs. 10.3 months for SoC. Results showed a prolonged OS benefit with an estimated 33.9% of patients alive at 18 months following treatment with Imfinzi plus chemotherapy vs. 24.7% of patients following SoC.

In addition, across all efficacy endpoints, benefits were observed in patients treated with Imfinzi plus chemotherapy vs. SoC. Results showed a significantly higher progression-free survival (PFS) rate at 12 months (17.5% vs. 4.7%), a 10.3% increase in confirmed objective response rate (ORR) (67.9% vs. 57.6%) and improved duration of response (DOR) at 12 months (22.7% vs. 6.3%).

These results were presented at the Presidential Symposium of the IASLC 2019 World Conference on Lung Cancer hosted by the International Association for the Study of Lung Cancer in Barcelona, Spain.

Further, the safety and tolerability of Imfinzi in combination with SoC etoposide and platinum-based chemotherapy was consistent with previous trials.

Imfinzi is also being tested following concurrent chemoradiation therapy in limited-stage SCLC in the phase III ADRIATIC trial. Imfinzi is approved in the curative-intent setting of unresectable, stage III non-small cell lung cancer after chemoradiotherapy in 49 countries, including the US, Japan and across the EU, based on the phase III PACIFIC trial.

AstraZeneca is focussed on the discovery, development and commercialisation of prescription medicines, primarily for the treatment of diseases in the three therapy areas of Oncology, CVRM and Respiratory.

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