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Today, AstraZeneca announced that its development of the PD-L1 monoclonal antibody Imfinzi (durvalumab) significantly improved the total survival of patients in Phase 3 clinical trials for the first-line treatment of widespread small cell lung cancer (ES-SCLC), reaching the main end of the trial. This cancer immunotherapy is expected to become the second PD-L1 inhibitor to be approved for first-line treatment of SCLC, after Roche's PD-L1 inhibitor Tecentriq.Lung cancer is the leading cause of cancer death, accounting for one-fifth of all cancer deaths. Lung cancer can be divided into non-small cell lung cancer (NSCLC) and SCLC, of which SCLC accounts for 15% of the total number of lung cancer. Nearly two-thirds of SCLC patients are already in a wide range of stages at the time of diagnosis, when the cancer has spread to the lungs or transferred to other parts of the body. SCLC is a highly aggressive, rapidly proliferating cancer that, although it may have an initial response to platinum-based chemotherapy, relapses and worsens rapidly. SCLC patients had a particularly poor prognostic period, with a survival rate of only 6% in the five years after diagnosis.
Developed by AstraZeneta, Imfinzi is a humanized anti-PD-L1 monoclonal antibody that relieves immunosuppression and enhances the body's immune system's ability to fight cancer by preventing PD-L1 from binding to PD-1 and CD80 receptors. It has been approved for the treatment of patients with advanced bladder cancer, and for patients with NSCLC who cannot be removed by stage 3.In an open-label, randomized global Phase 3 clinical trial called CASPIAN, a wide range of SCLC patients were treated with combination therapy based on Imfinzi or standard chemotherapy. Imfinzi combination therapies include: Imfinzi plus etoposide plus platinum-based chemotherapy options (cisplatin or carptin), or Imfinzi plus tremelimumab (anti-CTL4 antibody) plus chemotherapy.
In a preset interim analysis, the Independent Data Monitoring Board (IDMC) concluded that the trial had reached its main endpoint. Compared with standard chemotherapy, imfinzi-eposide-platinum-based chemotherapy has brought statistically significant and clinically significant improvements to the total survival of patients.
"The results of the CASPIAN Phase 3 clinical trial offer new hope for SCLC patients," said Dr. Jose Baselga, Executive Vice President of Oncology Research and Development at AstraZeneta. They face a catastrophic disease and urgently need innovative treatments. This clinical study provides the first flexibility to combine cancer immunotherapy with different platinum-based chemotherapy treatment options, broadening patients' treatment options. " (Drug Mingkang)