AstraZeneca announced Monday that the FDA expanded approval of Imfinzi (durvalumab) to include 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. The company noted that the PD-L1 inhibitor is the only immunotherapy cleared for this indication.
Dave Fredrickson, head of AstraZeneca's oncology business unit, said "globally, approximately 30 percent of patients with NSCLC present with Stage III disease and we are excited to launch the first immunotherapy into this setting." Imfinzi was granted FDA accelerated approval last year for the treatment of certain patients with locally-advanced or metastatic urothelial carcinoma.
According to AstraZeneca, the latest approval for Imfinzi is based on positive progression-free survival (PFS) data from the Phase III PACIFIC trial, which the company announced last year met its main goal. Results presented at the European Society of Medical Oncology (ESMO) congress showed that in the study, Imfinzi demonstrated an improvement in median PFS of 11.2 months compared to placebo, representing a 48 percent reduction in relative risk of progression or death in all patients, regardless of PD-L1 status.
At the time the results were reported, AstraZeneca indicated that overall survival (OS) remains under analysis in the trial. The FDA noted that as part of post-marketing commitments, the company will provide the agency additional information regarding OS in the study.
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Deutsche Bank analyst Richard Parkes said that the FDA approval of Imfinzi in lung cancer came around one month earlier than expected, with analysts predicting that the opportunity for the product in the stage III setting could be worth around $2 billion.
In September last year, the US 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 chemotherapy and radiation therapy. AstraZeneca is also studying the drug for the adjuvant treatment of patients with NSCLC, as well as in trials as monotherapy or in combination with other drugs for the first-line treatment of the condition.
For related analysis, see ViewPoints: AstraZeneca, Roche hang onto Merck's coattails in lung cancer race.
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