Durvalumab Immunotherapy Receives FDA Approval for First-Line Treatment of Small-Cell Lung Cancer

For the first-line treatment of advanced small-cell lung cancer, durvalumab (Imfinzi), an immunotherapy drug, received approval on March 27, 2020 for use with etoposide and either carboplatin or cisplatin chemotherapy from the FDA.

Small-cell lung cancer (SCLC) is a neuroendocrine tumor that accounts for approximately 15% of all lung cancers, almost all cases of which are caused by smoking. Compared with lung cancer cells that are not small-cell, its cells grow and divide more quickly and metastasize earlier.

At the time of diagnosis, small-cell lung cancer is most often at stage 4, and fewer types and numbers of drugs are available to treat this cancer than other lung cancers. Indeed, first-line (initial) treatment for advanced small-cell lung cancer had not changed for 40 years until atezolizumab (Tecentriq) received FDA approval on March 18, 2019, and median overall survival for this group of patients was around 10 months. In addition, although SCLC responds well to both chemotherapy and radiotherapy, the cancer recurs within months despite treatment.

FDA Approval of Durvalumab for Small-Cell Lung Cancer Based on the CASPIAN Study

On October 4, 2019, The Lancet published the CASPIAN study, which brought another new option to the first-line treatment of advanced small-cell lung cancer: the anti-PD-L1 immunotherapy durvalumab (Imfinzi).

The CASPIAN study enrolled more than 500 patients with advanced disease who had not previously received chemotherapy. Adding durvalumab to the standard platinum+etoposide doublet significantly prolonged survival compared with platinum + etoposide alone: 13 months versus 10.3 months. The survival and side-effect results in this study were similar to the results that had previously led to atezolizumab receiving FDA approval for first-line treatment of small-cell lung cancer in the IMpower133 study.

The most common (≥20%) side effects with the durvalumab plus etoposide-platinum triple regimen are nausea, fatigue and hair loss.

Recommended dose: For advanced small-cell lung cancer, durvalumab is to be administered before chemotherapy on the same day. When given with etoposide and either carboplatin or cisplatin, the recommended durvalumab dose is 1500 mg before chemotherapy every 3 weeks, followed by administration as a single agent every 4 weeks.

Note: This is durvalumab's 3rd FDA approval. It had previously received approval for second-line treatment of advanced bladder cancer in May 2017 and FDA approval in February 2018 for maintenance treatment of unresectable stage III non-small-cell lung cancer. This immunotherapy has not yet entered use in Türkiye.