Today, AstraZeneca voluntarily withdrew the indication of durvalumab (Imfinzi®, AstraZeneca) for patients with previously treated locally advanced or metastatic urothelial carcinoma based on results of the phase 3 DANUBE trial (NCT02516241), which did not meet its primary end points. The withdrawal does not affect durvalumab's indications for non-small cell lung cancer or for extensive stage small-cell lung cancer. Durvalumab, a human monoclonal antibody that binds to programmed death ligand 1 (...

 The FDA recently approved new doses of durvalumab (Imfinzi®, AstraZeneca) for the treatment of patients with previously treated advanced urothelial carcinoma and unresectable stage III non-small cell lung cancer. "Durvalumab, a selective, high-affinity, engineered human IgG1 mAb that blocks PD-L1 binding to PD-1 and CD80, is approved in the US, Japan, and several other countries for the treatment of patients with unresectable, stage III NSCLC whose disease has not progressed following conc...

In this interview, Jonathan Goldman, MD, speaks with i3 Health about the recent FDA approval of durvalumab (Imfinzi®, AstraZeneca) in combination with platinum/etoposide for patients with extensive-stage small-cell lung cancer (ES-SCLC). The approval was based on CASPIAN, a phase 3 trial in which durvalumab/platinum/etoposide significantly increased median overall survival and produced a higher overall response rate compared with platinum/etoposide alone. Dr. Goldman, Associate Professor of Hema...

The FDA has approved durvalumab (Imfinzi®, AstraZeneca) in combination with either carboplatin/etoposide or cisplatin/etoposide for patients with previously untreated extensive-stage small-cell lung cancer (ES-SCLC). The approval was based on CASPIAN (NCT03043872), a phase 3 trial that enrolled 537 patients with untreated ES-SCLC. Patients were randomized in a 1:1:1 ratio to receive durvalumab/platinum/etoposide, durvalumab/tremelimumab/platinum/etoposide, or platinum/etoposide alone. Platinum-b...

Because most patients with small-cell lung cancer (SCLC) present with extensive-stage disease—in which the cancer has spread to both lungs or throughout the body—survival rates are poor, and there is a need to develop alternative treatments to improve outcomes. In their study now published in The Lancet, Luis Paz-Ares, MD, and colleagues found that in patients with extensive-stage SCLC (ES-SCLC), the addition of the immunotherapy drug durvalumab to a chemotherapy regimen of platinum/etoposide si...