AstraZeneca's PD-L1 Therapy Imfinzi Combination Meets Primary Endpoint in Phase 3 Trial for First-Line Extensive-Stage Small Cell Lung Cancer

Today, AstraZeneca announced that Imfinzi (durvalumab), its PD-L1 monoclonal antibody, significantly improved overall survival in patients and met the primary endpoint of a Phase 3 clinical trial for first-line treatment of extensive-stage small cell lung cancer (ES-SCLC). This cancer immunotherapy is poised to become the second PD-L1 inhibitor approved for first-line treatment of SCLC, following Roche’s PD-L1 inhibitor Tecentriq.

Lung cancer is the leading cause of cancer-related deaths, accounting for one-fifth of all cancer fatalities. Lung cancer can be categorized into two major types: non-small cell lung cancer (NSCLC) and small cell lung cancer (SCLC), with SCLC comprising 15% of all lung cancer cases. Nearly two-thirds of patients with SCLC are diagnosed at the extensive stage, by which time the cancer has already spread within the lungs or metastasized to other parts of the body. SCLC is a highly aggressive and rapidly proliferating malignancy; although it may initially respond to platinum-based chemotherapy, it often relapses and progresses rapidly. The prognosis for patients with SCLC is particularly poor, with a 5-year survival rate of only 6% following diagnosis.

Imfinzi, developed by AstraZeneca, is a humanized anti-PD-L1 monoclonal antibody that relieves immunosuppression and enhances the body’s immune system to fight cancer by preventing PD-L1 from binding to the PD-1 and CD80 receptors. It has been approved for the treatment of patients with previously treated advanced bladder cancer and patients with previously treated stage 3 unresectable non-small cell lung cancer (NSCLC).

In the open-label, randomized, global Phase 3 CASPIAN trial, patients with extensive-stage small cell lung cancer (SCLC) received either Imfinzi-based combination therapy or standard chemotherapy. The Imfinzi combination regimens included: Imfinzi plus etoposide and platinum-based chemotherapy (cisplatin or carboplatin), or Imfinzi plus tremelimumab (an anti-CTLA-4 antibody) and chemotherapy.

In the prespecified interim analysis, the Independent Data Monitoring Committee (IDMC) determined that the trial had met its primary endpoint. Imfinzi plus etoposide and platinum-based chemotherapy demonstrated a statistically significant and clinically meaningful improvement in overall survival compared with standard chemotherapy.

Dr. José Baselga, Executive Vice President of Oncology R&D at AstraZeneca, said, “The results of the Phase III CASPIAN clinical trial bring new hope to patients with small cell lung cancer (SCLC). They face a devastating disease and are in urgent need of innovative therapies. This clinical study provides, for the first time, the flexibility to combine cancer immunotherapy with different platinum-based chemotherapy regimens, thereby broadening treatment options for patients.”

References:

[1] Imfinzi improves overall survival at interim analysis in the Phase III CASPIAN trial in 1st-line extensive-stage small cell lung cancer. Retrieved June 27, 2019, from https://www.astrazeneca.com/media-centre/press-releases/2019/imfinzi-improves-overall-survival-at-interim-analysis-in-the-phase-iii-caspian-trial-in-1st-line-extensive-stage-small-cell-lung-cancer-27062019.html

Flash Update | First-Line Therapy Improves Overall Survival in Small Cell Lung Cancer; AstraZeneca’s PD-L1 Inhibitor Combination Meets Phase 3 Clinical Trial Endpoints

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