FDA Approves New First-Line Treatment for Metastasized Small Cell Lung Cancer

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

REFERENCES

• 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.