“We are pleased to see the sustained and meaningful survival benefit of Imfinzi for patients with small cell lung cancer after more than two years median follow up,” said Jose Baselga, Astra Zeneca’s executive vice president, Oncology R&D.
AstraZeneca reported that high-level data analysis from its Phase III CASPIAN trial demonstrated that Imfinzi (durvalumab) in combination with standard-of-care (SoC) chemotherapies confirmed a clinically meaningful and sustained overall survival (OS) benefit in patients with extensive-stage small cell lung cancer (ES-SCLC) treated in the first-line setting.
Back in June 2019, the CASPIAN trial hit one primary endpoint, showing a statistically significant and clinically meaningful improvement in OS compared to SoC alone during a planned interim analysis. A second experimental arm evaluated tremelimumab, an anti-CTLA4 monoclonal antibody with Imfinzi and SoC, however, failed to meet the primary endpoint of statistically significant improvement in OS.
Imfinzi is a checkpoint inhibitor. It is approved in the curative-intent setting of Stage III NSCLC after chemoradiation that is unresectable and has been approved for first-line therapy of ES-SCLC in combination with SoC in Singapore. It has also been approved for previously treated patients with advanced bladder cancer in the U.S. and a few other countries.
Tremelimumab, as mentioned above, is an experimental drug that targets cytotoxic T-lymphocyte-associated protein 4 (TCLA-4). It blocks the activity of CTLA-4, helping with T-cell activation, which primes the immune system to respond to cancer. It is being studied in combination with Imfinzi in NSCLC, SCLC, bladder cancer, head and neck cancer and liver cancer.
“We are pleased to see the sustained and meaningful survival benefit of Imfinzi for patients with small cell lung cancer after more than two years median follow up,” said Jose Baselga, Astra Zeneca’s executive vice president, Oncology R&D. “We have already received the first global regulatory approval for Imfinzi with etoposide plus either carboplatin or cisplatin and remain on track for more approvals soon as we provide patients an important new first-line treatment option.”
The CASPIAN Phase III trial evaluated first-line treatment of 805 patients with ES-SCLC, comparing Imfinzi in combination with episode and either carboplatin or cisplatin chemotherapy, or Imfinzi and chemotherapy with another immunotherapy, tremelimumab, versus chemotherapy alone. It was conducted in more than 200 sites in 23 countries, including the U.S., Europe, South America, Asia and the Middle East.
Lung cancer is the leading cause of death from cancer in both men and women and makes up about 20% of all cancer deaths. It is broadly divided into non-small cell lung cancer (NSCLC) and SCLC, with about 15% classified as SCLC. SCLC is very aggressive and fast-growing that usually recurs and progresses quickly despite early response to chemotherapy. About two thirds of SCLC patients are eventually diagnosed with extensive-stage diseases, where the cancer has widely metastasized through the lung and to other parts of the body. Prognosis is poor, with only 6% of SCLC patients alive five years after initial diagnosis.
On March 6, the company reported on the Phase III DANUBE trial of Imfinzi and Imfinzi plus tremelimumab in unresectable, Stage IV bladder cancer. It did not meet the primary endpoints of improving overall survival (OS) compared to SoC chemotherapy for Imfinzi alone in tumors that express high levels of PD-L1 or for Imfinzi plus tremelimumab in patients regardless of the PD-L1 expression.
