FDA Approves New First-Line Treatment for Metastasized Small Cell Lung Cancer
Small cell lung cancer is highly aggressive and fast-growing, typically recurring and progressing rapidly despite the initial response to chemotherapy.
The FDA has approved durvalumab (Imfinzi, AstraZeneca), in combination with etoposide and either carboplatin or cisplatin, as a new first-line treatment for patients with extensive-stage small cell lung cancer (ES-SCLC).1
SCLC is highly aggressive and fast-growing, typically recurring and progressing rapidly despite the initial response to chemotherapy.1 In total, lung cancer accounts for approximately 20% of all cancer-related deaths, and approximately 15% of those with lung cancer are diagnosed with SCLC. Approximately two-thirds of those patients are later diagnosed with ES-SCLC, in which the cancer has spread widely throughout the lung or to other parts of the body. Only approximately 6% of all patients with SCLC will be alive 5 years after diagnosis.1
Durvalumab is a human monoclonal antibody that binds to programmed death-ligand 1 (PD-L1) and counters the tumor’s immune-evading tactics. It was previously approved in the curative-intent setting for unresectable non-small cell lung cancer (NSCLC) after chemoradiation therapy. It is also being tested alone and in combination with tremelimumab as a treatment for patients with NSCLC, SCLC, bladder cancer, head and neck cancer, liver cancer, biliary tract cancer, cervical cancer, and other solid tumors.1
The FDA approval was based on the phase 3 CASPIAN trial, which showed a statistically significant and clinically meaningful improvement in overall survival among patients receiving durvalumab in combination with standard-of-care platinum etoposide.1
The trial enrolled 805 patients diagnosed with ES-SCLC. Researchers compared durvalumab in combination with etoposide and either carboplatin or cisplatin chemotherapy, durvalumab and chemotherapy with tremelimumab, or chemotherapy alone.1
The median overall survival was 13 months in the durvalumab plus chemotherapy arm of the trial, compared with 10.3 months in patients receiving chemotherapy alone.1
The most common adverse reactions included nausea, fatigue/asthenia, and alopecia.1
For patients with ES-SCLC, durvalumab is approved to be administered prior to chemotherapy on the same day. When administered with etoposide and either carboplatin or cisplatin, the recommended dose is 1500 mg every 3 weeks prior to chemotherapy, followed by every 4 weeks as a single agent.2
For this new indication, the application was granted priority review and orphan drug status.2
- Imfinzi approved in the US for extensive-stage small cell lung cancer [news release]. AstraZeneca; March 30, 2020. https://www.astrazeneca.com/media-centre/press-releases/2020/imfinzi-approved-in-the-us-for-extensive-stage-small-cell-lung-cancer.html. Accessed March 30, 2020.
- FDA approves durvalumab for extensive-stage small cell lung cancer [news release]. FDA; March 30, 2020. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-durvalumab-extensive-stage-small-cell-lung-cancer. Accessed March 30, 2020.