AstraZeneca's Imfinzi clears another FDA hurdle

AstraZeneca and MedImmune, its global biologics research and development arm, announced on Monday that the US Food and Drug Administration has approved Imfinzi 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).

The FTSE 100 drugmaker said the approval of Imfinzi was based on the positive progression-free survival data from the Phase III PACIFIC trial, in which the therapy demonstrated an improvement in median progression-free survival of 11.2 months compared to placebo, representing a 48% reduction in relative risk of progression or death when compared to placebo in all patients, regardless of PD-L1 status.

It said the PACIFIC trial was ongoing to evaluate overall survival in unresectable Stage III NSCLC.

Detailed interim results of the PACIFIC trial were published online in the New England Journal of Medicine.

Overall, it said 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 were cough, fatigue, pneumonitis or radiation pneumonitis, upper respiratory tract infections, dyspnoea, and rash.

Discontinuation after concurrent chemoradiation therapy due to adverse reactions, regardless of causality, occurred in 15% of patients receiving Imfinzi compared to 10% of patients receiving placebo.

On 28 September last year, the National Comprehensive Cancer Network’s 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 chemoradiation therapy.

“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,” said Dave Fredrickson, executive vice-president and head of the AstraZeneca oncology business unit.

“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 Antonia, chair of the thoracic oncology department at the H. Lee Moffitt Cancer Center and Research Institute in Tampa and investigator in the PACIFIC trial, said that until now, treatment guidelines 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.”