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New Durvalumab Dosing Schedule Approved for Urothelial Carcinoma and Non-Small Cell Lung Cancer

Durvalumab.

 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 concurrent chemoradiotherapy cCRT," write the authors of PACIFIC, one of the trials on which the new dosing was based, led by Jeffrey D. Bradley, Executive Vice Chair of the Department of Radiation Oncology at Emory University School of Medicine. Durvalumab is also approved for the treatment of patients with unresectable, locally advanced or metastatic urothelial carcinoma. Previously approved for a dose of 10 mg/kg every two weeks for patients weighing at least 30 kg, durvalumab is now also approved for a fixed dose of 1,500 mg every four weeks, until disease progression or unacceptable toxicity.

The new dosing schedule was based on the results of two randomized phase 3 trials. The PACIFIC trial enrolled 713 patients with unresectable, stage III NSCLC who were randomized to receive intravenous durvalumab or placebo. At a median follow-up of 33.3 months, patients receiving durvalumab experienced significantly improved median overall survival versus placebo (not reached vs 29.1 months), as well as a higher 36-month overall response rate (57% vs 43.5%).

In DANUBE, another open-label phase 3 trial published in The Lancet Oncology, 1,032 patients with metastatic urothelial carcinoma were enrolled in a 1:1:1 ratio to receive durvalumab 1,500 mg every four weeks, durvalumab plus tremelimumab, or standard-of-care chemotherapy. At a median follow-up of 41.2 months, overall survival was 14.4 months in the durvalumab monotherapy group versus 12.1 months in the chemotherapy group. In the intention-to-treat population, median overall survival was 15.1 months in the durvalumab/tremelimumab group and 12.1 months in the chemotherapy group. Grade 3 or 4 treatment-related adverse events occurred in 14% of patients in the durvalumab group, 27% of patients in the durvalumab/tremelimumab group, and 60% of patients in the chemotherapy group.

For patients with previously treated advanced urothelial carcinoma or stage III unresectable NSCLC, the new approved dosage of durvalumab is 1,500 mg every four weeks, as an alternative to the prior approved dosage of 10 mg/kg every two weeks for patients who weigh 30 kg or more.

For More Information

Powles T, van der Heijden MS, Galsky MD et al (2020). Durvalumab alone and durvalumab plus tremelimumab versus chemotherapy in previously untreated patients with unresectable, locally advanced or metastatic urothelial carcinoma (DANUBE): a randomized, open-label, multicentre, phase 3 trial, The Lancet Oncol, [Epub ahead of print] DOI:10.1016/S1470-2045(20)30541-6

Gray JE, Villegas AE, Daniel DB, et al (2019). Three-year overall survival update from the PACIFIC trial. J Clin Oncol. (ASCO Annual Meeting Abstracts), 37(suppl_15). Abstract 8536. DOI:10.1200/JCO.2019.37.15_suppl.8536

Gray JE, Villegas AE, Daniel DB, et al (2019). Three-year overall survival update from the PACIFIC trial. J Clin Oncol. (ASCO Annual Meeting Abstracts), 37(suppl_15). Abstract 8536. DOI:10.1200/JCO.2019.37.15_suppl.8536

Imfinzi® (durvalumab) prescribing information (2020). AstraZeneca. Available at: https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761069s023s024s025lbl.pdf


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