FDA Approves Imfinzi for Patients with Extensive-Stage Small Cell Lung Cancer

The Food and Drug Administration (FDA) on Monday approved Imfinzi (durvalumab) as part of a combination treatment for extensive-stage small cell lung cancer (ES-SCLC).

Imfinzi was approved in combination with etoposide plus either carboplatin or cisplatin, all considered standard-of-care chemotherapies, as a first-line treatment option for adults with ES-SCLC. Imfinzi, a human monoclonal antibody, counters the tumor's immune-evading tactics and releases the inhibition of immune responses.

Approximately two-thirds of patients diagnosed with small cell lung cancer (SCLC) are diagnosed with ES-SCLC, which means the cancer has spread throughout the lung or to other parts of the body. Prognosis is rather poor, as 6% of all patients with SCLC will be alive five years after diagnosis.

“Patients with extensive-stage small cell lung cancer continue to face a poor prognosis and finding new medicines to improve outcomes in this setting has been a formidable challenge,” lead study author Dr. Jonathan Goldman, an associate professor of hematology and oncology at UCLA Medical Center, said in a press release. “The CASPIAN trial enables clinicians to choose durvalumab in combination with etoposide and either carboplatin or cisplatin, making this an important new first-line treatment option for patients that is both effective and well-tolerated.”

The FDA approved Imfinzi based on the results of a clinical trial involving 805 patients with ES-SCLC. Patients received either Imfinzi in combination with etoposide and either carboplatin or cisplatin chemotherapy, or Imfinzi and chemotherapy with the addition of tremelimumab (an immune checkpoint blocker), versus chemotherapy alone.

The primary outcome of the trial, known as the phase 3 CASPIAN trial, was overall survival. Patients who received Imfinzi plus standard-of-care chemotherapy had a 27% lower risk of death and had a median overall survival of 13 months versus 10.3 months for patients who received standard-of-care chemotherapies alone.

Check back later for what you need to know about this approval.