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FDA Approves Durvalumab for Extensive-Stage Small Cell Lung Cancer

Evidence for efficacy is based on findings from the CASPIAN study
03 Apr 2020
Cancer Immunology and Immunotherapy;  Lung and other thoracic tumours

On 27 March 2020, the US Food and Drug Administration (FDA) approved durvalumab (IMFINZI, AstraZeneca) in combination with etoposide and either carboplatin or cisplatin as first-line treatment of patients with extensive-stage small cell lung cancer (ES SCLC).

Efficacy of this combination in patients with previously untreated ES SCLC was investigated in CASPIAN, a randomised, multicentre, active-controlled, open-label, trial (NCT03043872). The evaluation was based on the comparison of patients randomised to durvalumab plus chemotherapy vs. chemotherapy alone. The major efficacy outcome measure was overall survival (OS). Additional efficacy outcome measures were investigator-assessed progression-free survival (PFS) and objective response rate (ORR), per RECIST v1.1. 

Median OS was 13.0 months (95% confidence interval [CI] 11.5, 14.8) in the durvalumab plus chemotherapy arm compared with 10.3 months (95% CI 9.3, 11.2) in the chemotherapy alone arm (hazard ratio [HR] 0.73; 95% CI 0.59, 0.91; p = 0.0047).

Investigator-assessed PFS (96% of total planned events) showed a HR of 0.78 (95% CI 0.65, 0.94), with median PFS of 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.

The 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.

The most common adverse reactions (≥20%) in patients with ES SCLC were nausea, fatigue/asthenia, and alopecia.

For ES SCLC, durvalumab is to be administered prior to chemotherapy on the same day. The recommended durvalumab dose when administered with etoposide and either carboplatin or cisplatin is 1500 mg every 3 weeks prior to chemotherapy and then every 4 weeks as a single agent.

Full prescribing information for IMFINZI is available here.

This review used the Assessment Aid, a voluntary submission from the applicant to facilitate the FDA’s assessment.

FDA granted this application priority review and granted durvalumab orphan drug designation for this indication.

Healthcare professionals should report all serious adverse events suspected to be associated with the use of any medicine and device to FDA’s MedWatch Reporting System.

For assistance with single-patient INDs for investigational oncology products, healthcare professionals may contact the FDAs’ Oncology Center of Excellence Project Facilitate.

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