For the First Time, an Immunotherapy (Durvalumab) Received FDA Approval for Stage 3 Lung Cancer

The immunotherapy drug durvalumab (brand name Imfinzi), for patients with unresectable stage 3 non-small cell lung cancer whose disease has not worsened after concurrent chemotherapy and radiotherapy, received approval on 16 February 2018 from the FDA .

Unresectable stage 3 non-small cell lung cancer has been a difficult treatment area for years, prompting the search for new options. Standard treatment is chemotherapy with radiotherapy (chemoradiotherapy). Despite combining our two most important treatments, only 15% of patients live five years or longer. Durvalumab became the first treatment approved to reduce lung cancer progression risk at this stage. All previous immunotherapy approvals in lung cancer had been for advanced (stage 4 = metastatic) disease .

Imfinzi, containing durvalumab, is an immunotherapy drug that blocks PDL-1, a protein that makes our defense cells blind to cancer, helping them recognize and destroy cancer cells. Previous FDA approvals for durvalumab were for locally advanced or metastatic bladder cancer.

The randomized phase 3 PACIFIC trial involved 26 countries and 235 cancer centers. It enrolled 713 patients with stage 3 non-small cell lung cancer in a 2-to-1 ratio. All received chemoradiotherapy, after which 2/3 received durvalumab at 10 mg/kg every two weeks for 12 months, while the other group received placebo (a drug containing no active ingredient).

Median time until disease progression was 16.8 months in immunotherapy recipients versus 5.6 months in those receiving chemoradiotherapy alone.

Durvalumab reduced lung cancer progression by 48%. Objective response was significantly higher in the immunotherapy arm, at 28% with durvalumab versus 16% with placebo.

Although side effects were more frequent with durvalumab, they were manageable.

- Related topic: How are side effects of immunotherapies, the most popular cancer treatments of recent years, treated?

In stage 3 lung cancer, many drugs previously tested to reduce worsening after chemoradiotherapy had failed, making this an important advance. This approval changes the treatment strategy for stage 3 non-small cell lung cancer.