FDA Approves Durvalumab for Extensive-Stage Small Cell Lung Cancer

March 31, 2020

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.

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.