FDA Approves Durvalumab for Extensive-Stage Small Cell Lung Cancer

News
Article

Officials with the FDA have approved durvalumab (Imfinzi) for the first-line treatment of extensive-stage small cell lung cancer (ES-SCLC), in combination with standard-of-care (SoC) chemotherapies, in adult patients.

Lung Cancer

Officials with the FDA have approved durvalumab (Imfinzi) for the first-line treatment of extensive-stage small cell lung cancer (ES-SCLC), in combination with standard-of-care (SoC) chemotherapies, in adult patients, according to a press release.

Durvalumab is also indicated for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma, as well as unresectable stage 3 non-small cell lung cancer.

The approval is based on data from the phase 3 CASPIAN trial showing durvalumab plus sOc platinum-etoposide demonstrated a statistically significant and clinically meaningful improvement in overall survival (OS) compared with sOc alone.

For the study, the 2 primary endpoints compared experimental arms with SoC. Patients were enrolled to either the durvalumab plus platinum-etoposide group or the platinum-etoposide group. In the experimental arms of the trial, patients were treated with 4 cycles of chemotherapy. In the comparison arm, a fixed dose of durvalumab 1500 mg was administered every 3 weeks for 4 cycles while in combination with chemotherapy and then every 4 weeks until disease progression as a single medicine.

Overall, durvalumab plus SoC was associated with a 27% reduction in the risk of death (equal to a hazard ratio of 0.73; 95% CI 0.59-0.91; p=0.0047), with a median overall survival (OS) of 13 months versus 10.3 months for SoC alone. Thirty-four percent versus 25% of patients, respectively, were alive at 18 months, according to the study.

Additionally, the data showed an increased confirmed objective response rate in the durvalumab plus SoC arm (68% versus 58% for SoC alone).

The safety profile for durvalumab plus SoC was consistent with the known safety profiles of these medicines. The most common adverse effects were nausea, fatigue/asthenia, and alopecia.

“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 investigator Jonathan Goldman, MD, associate professor of Hematology & Oncology, UCLA Medical Center, said in a statement. “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.”

 

References:

1. IMFINZI (durvalumab) approved in the US for extensive-stage small cell lung cancer [news release]. AstraZeneca’s website. https://www.astrazeneca-us.com/content/az-us/media/press-releases/2020/imfinzi-durvalumab-approved-in-the-us%20for-extensive-stage-small-cell-lung-cancer-03302020.html#!. Accessed March 31, 2020.

 

Newsletter

Pharmacy practice is always changing. Stay ahead of the curve with the Drug Topics newsletter and get the latest drug information, industry trends, and patient care tips.

Recent Videos
Related Content
© 2025 MJH Life Sciences

All rights reserved.