AstraZeneca's Imfinzi Receives FDA Approval as First-Line Treatment for Extensive-Stage Small Cell Lung Cancer

From Jike Pharma News

On March 30, AstraZeneca announced that Imfinzi (durvalumab) was approved in the United States as a first-line treatment for adult patients with extensive-stage small cell lung cancer (ES-SCLC), to be used in combination with standard of care (SoC) chemotherapy consisting of etoposide plus carboplatin or cisplatin (platinum-etoposide). The FDA approval was based on positive results from the Phase 3 CASPIAN clinical trial, which demonstrated that Imfinzi combined with SoC platinum-etoposide provided a statistically significant and clinically meaningful improvement in overall survival (OS) compared to SoC chemotherapy alone.

In the open-label, randomized, global Phase 3 CASPIAN trial, patients with extensive-stage small cell lung cancer (ES-SCLC) received either Imfinzi-based combination therapy or standard-of-care (SoC) chemotherapy. The Imfinzi combination regimens included Imfinzi plus SoC, or Imfinzi plus tremelimumab (an anti-CTLA-4 antibody) plus SoC. In the CASPIAN trial, fixed-dose Imfinzi (1500 mg) was administered every three weeks for four cycles in combination with chemotherapy, followed by administration every four weeks until disease progression. In the Imfinzi plus SoC arm, the risk of death was reduced by 27% (hazard ratio [HR] 0.73; 95% CI 0.59–0.91; p=0.0047), with a median overall survival (OS) of 13.0 months compared to 10.3 months in the SoC-alone arm. Results also demonstrated an increased confirmed objective response rate (ORR) in the Imfinzi plus SoC group (68% vs. 58% in the SoC-alone group). The safety and tolerability profile of Imfinzi plus SoC was consistent with the known safety profiles of these agents. Data from the Phase 3 CASPIAN trial of Imfinzi plus SoC were published in The Lancet. The clinical trial for the experimental arm of Imfinzi plus tremelimumab (an anti-CTLA-4 antibody) plus SoC has recently been completed but did not meet its primary endpoint. Detailed results will be presented at upcoming medical conferences.

Lung cancer is the leading cause of cancer-related deaths in both men and women, accounting for approximately one-fifth of all cancer fatalities. About 15% of lung cancers are small cell lung cancer (SCLC), a highly aggressive and rapidly growing form of the disease that, despite an initial response to chemotherapy, typically recurs and progresses quickly. Approximately two-thirds of SCLC patients are diagnosed with extensive-stage SCLC (ES-SCLC), where the cancer has spread widely within the lungs or to other parts of the body. The prognosis is particularly poor; statistically, only 6% of patients with small cell lung cancer survive beyond five years. As part of an extensive development program, Imfinzi is also being evaluated in the Phase 3 ADRIATIC clinical trial in patients with limited-stage SCLC following concurrent chemoradiotherapy, with data expected in 2021.

Based on the Phase 3 CASPIAN clinical trial conducted in Singapore for patients with extensive-stage small cell lung cancer (ES-SCLC), Imfinzi received its initial approval in Singapore in February 2020 for this indication. Based on the Phase 3 CASPIAN trials conducted in the European Union and Japan, the supplemental Biologics License Application (sBLA) for Imfinzi in combination with etoposide and either carboplatin or cisplatin as first-line treatment for ES-SCLC is currently under regulatory review in the EU and Japan. Previously, on November 30, 2019, the sBLA for Imfinzi in the treatment of small cell lung cancer was granted Priority Review by the U.S. Food and Drug Administration (FDA). Dave Fredrickson, Executive Vice President of AstraZeneca’s Oncology Business Unit, stated: “The FDA approval of Imfinzi for the treatment of extensive-stage small cell lung cancer brings a new therapeutic option to patients in urgent need of novel treatments. Imfinzi is the only immunotherapy that has demonstrated both a significant survival benefit and improved response rates when combined with chemotherapy in these patients, marking an important step forward in the treatment of this devastating disease.”

Jonathan Goldman, MD, Associate Professor of Hematology and Oncology at the UCLA Medical Center in Santa Monica, California, and principal investigator of the Phase 3 CASPIAN trial, stated, “Patients with extensive-stage small cell lung cancer continue to face a poor prognosis, and identifying new agents to improve treatment outcomes in this setting remains a significant challenge. The CASPIAN trial enables clinicians to select durvalumab in combination with etoposide and either carboplatin or cisplatin, establishing it as an important new first-line treatment option for patients who require effective and well-tolerated therapy.”

References:

[1] Imfinzi approved in the US for extensive-stage small cell lung cancer. Retrieved 2020-03-30, from https://www.astrazeneca.com/media-centre/press-releases/2020/imfinzi-approved-in-the-us-for-extensive-stage-small-cell-lung-cancer.html

Original Title: Imfinzi Approved by the U.S. FDA for First-Line Treatment of Small Cell Lung Cancer

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