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IMFINZI (Durvalumab) is the Only Immunotherapy to Demonstrate Overall Survival at Three Years in Unresectable, Stage III Non-Small Cell Lung Cancer

Nachrichtenquelle: Business Wire (engl.)
02.06.2019, 15:00  |  1132   |   |   

AstraZeneca has presented three-year overall survival (OS) results from the Phase III PACIFIC trial of IMFINZI (durvalumab) in unresectable, Stage III non-small cell lung cancer (NSCLC) during the 2019 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago.

The latest results from this post-hoc analysis show longer-term OS evidence in patients with unresectable, Stage III NSCLC who had not progressed following concurrent chemoradiation therapy (CRT), a previous standard-of-care (SoC) treatment. The OS rate was 57% at three years for patients receiving IMFINZI vs. 43.5% for placebo following concurrent CRT. Median OS was not yet reached with the IMFINZI arm versus 29.1 months for placebo.

Dave Fredrickson, Executive Vice President, Oncology Business said: “These findings for IMFINZI are another example of our focus on bringing long-term survival benefits to patients who still have a chance of being cured. These three-year survival results further establish the PACIFIC regimen as the standard of care for these patients, and we are optimistic that this survival trend will continue as we move towards the five-year landmark in this curative-intent setting.”

Results build on the primary two-year OS analysis that was published in The New England Journal of Medicine in September 2018 and demonstrated a significant OS benefit for treatment with IMFINZI vs. placebo after CRT, regardless of PD-L1 expression. The primary analysis showed IMFINZI reduced the risk of death by 32% (HR 0.68, 99.73% CI 0.47-0.997; p=0.0025).

With the additional year of follow up, the latest results for IMFINZI showed consistent efficacy, maintaining a 31% reduction in the risk of death vs. placebo after CRT (HR 0.69, [95% CI 0.55-0.86]).

Jhanelle Gray, MD, Director of Clinical Research in the Thoracic Oncology Department at Moffitt Cancer Center in Tampa, Florida, and an investigator in the PACIFIC trial, said: “In the past, patients with unresectable, Stage III non-small cell lung cancer faced five-year survival rates of only 15 to 30%. It is remarkable to see more than half of the patients treated with the PACIFIC regimen alive after three years, an important milestone in this curative-intent setting.”

IMFINZI can cause serious, potentially fatal adverse events (AEs). In the previous two-year OS analysis, the most common adverse reactions (greater than or equal to 20% of patients) for patients receiving IMFINZI versus placebo were cough (35.2% vs. 25.2%), fatigue (24.0% vs. 20.5%), dyspnea (22.3% vs. 23.9%) and radiation pneumonitis (20.2% vs. 15.8%). 30.5% of patients experienced a grade 3 or 4 AE with IMFINZI vs. 26.1% with placebo, and 15.4% of patients discontinued treatment due to AEs with IMFINZI vs. 9.8% of patients on placebo.

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