03/20/2018

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AstraZeneca's New FDA Approval

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US FDA approves IMFINZI® (durvalumab) for unresectable Stage III non-small cell lung cancer
February 16, 2018
 
IMFINZI is the only immunotherapy approved for patients with unresectable Stage III non-small cell lung cancer.

IMFINZI showed an 11.2 month improvement in median progression-free survival (16.8 months compared to 5.6 months on placebo).

AstraZeneca and MedImmune, its global biologics research and development arm, today announced that the US Food and Drug Administration (FDA) has approved IMFINZI® (durvalumab) for the treatment of patients with unresectable Stage III non-small cell lung cancer (NSCLC) whose disease has not progressed following concurrent platinum-based chemotherapy and radiation therapy (CRT).

Dave Fredrickson, Executive Vice President, Head of the Oncology Business Unit at AstraZeneca, said: "The approval of IMFINZI in this earlier stage of non-small cell lung cancer is a truly meaningful milestone for patients who, until now, had no FDA-approved treatment options following chemoradiation therapy. Globally, approximately 30% of patients with NSCLC present with Stage III disease and we are excited to launch the first immunotherapy into this setting.”

Scott J. Antonia, M.D., Ph.D., Chair of the Thoracic Oncology Department at the H. Lee Moffitt Cancer Center and Research Institute in Tampa, Florida and investigator in the PACIFIC trial, said: “Until now, treatment guidelines have recommended that patients with unresectable Stage III lung cancer undergo a period of active surveillance following chemoradiation therapy until disease progression. Given that up to 89% of patients will progress to metastatic disease, it is important that there is now a new option that can give patients more time without disease progression. The PACIFIC trial data supporting today’s approval of IMFINZI will change how we treat these patients.”

The approval of IMFINZI is based on the positive PFS data from the Phase III PACIFIC trial in which IMFINZI demonstrated an improvement in median PFS of 11.2 months compared to placebo, representing a 48% reduction in relative risk of progression or death vs placebo in all patients, regardless of PD-L1 status. The PACIFIC trial is ongoing to evaluate overall survival (OS) in unresectable Stage III NSCLC. Detailed interim results of the PACIFIC trial were published online in the New England Journal of Medicine.

Overall, the incidence and severity of adverse events were comparable for patients receiving Imfinzi and the patients receiving placebo. In patients receiving Imfinzi, the most common adverse reactions (greater than or equal to 20% of patients) were cough (40%), fatigue (34%), pneumonitis or radiation pneumonitis (34%), upper respiratory tract infections (26%), dyspnoea (25%), and rash (23%). Discontinuation after concurrent CRT due to adverse reactions, regardless of causality, occurred in 15% of patients receiving Imfinzi vs. 10% of patients receiving placebo.

On September 28, 2017, the National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology were updated to include Imfinzi for the treatment of patients with unresectable Stage III NSCLC with no disease progression after two or more cycles of concurrent CRT.

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