The Food and Drug Administration (FDA) has approved Imfinzi (durvalumab; AstraZeneca), a programmed death-ligand 1 (PD-L1) blocking antibody, for the first-line treatment of adult patients with extensive-stage small cell lung cancer (SCLC), in combination with etoposide and either carboplatin or cisplatin.
The approval was based on data from the CASPIAN study, an active-controlled, open-label trial that investigated the combination of durvalumab plus chemotherapy vs chemotherapy alone in previously untreated patients with extensive-stage SCLC (median age: 63 years; 70% male). Among the study population, 90% had Stage IV disease and 10% had brain metastasis at baseline. A total of 25% of patients received cisplatin and 74% received carboplatin. In the chemotherapy alone arm, 57% of patients received 6 cycles of chemotherapy, and 8% received prophylactic cranial irradiation. The primary end point was overall survival (OS); additional efficacy measures included investigator-assessed progression free survival (PFS) and objective response rate (ORR).
Results showed a median OS of 13.0 months in the durvalumab plus chemotherapy arm compared with 10.3 months in the chemotherapy alone arm (hazard ratio [HR] 0.73 [95% CI, 0.59-0.91]; P =.0047). In exploratory subgroup analyses of OS based on the platinum chemotherapy received at cycle 1, HR was 0.70 (95% CI, 0.55-0.89) in patients who received carboplatin and 0.88 (95% CI, 0.55-1.41) in those who received cisplatin.
Additionally, median PFS was observed to be 5.1 months (95% CI, 4.7-6.2) in the durvalumab plus chemotherapy arm and 5.4 months (95% CI, 4.8-6.2) in the chemotherapy alone arm (HR 0.78 [95% CI, 0.65-0.94]. Investigator-assessed confirmed ORR was 68% (95% CI, 62%-73%) in the durvalumab plus chemotherapy arm and 58% (95% CI, 52%-63%) in the chemotherapy alone arm.
With regard to safety, the most common adverse reactions reported in study patients included nausea, fatigue/asthenia, and alopecia.
Commenting on the approval, Dave Fredrickson, Executive Vice President, Oncology Business Unit, said: “Imfinzi is the only immunotherapy to show both a significant survival benefit and improved response rate in combination with chemotherapy for these patients, an important step forward in treating this devastating disease.”
Imfinzi is also indicated for the treatment of locally advanced or metastatic urothelial carcinoma and for unresectable Stage III non-small cell lung cancer.
For more information visit astrazeneca-us.com.
This article originally appeared on MPR