In a press release on November 20, 2020, the manufacturer of human monoclonal antibody Imfinzi  (durvalumab) announced that the FDA approved an additional dosing option, a 1,500-mg fixed-dose every 4 weeks in the approved indications of unresectable stage III non-small cell lung cancer (NSCLC) after chemoradiation therapy (CRT) and previously treated advanced bladder cancer.

This new option is consistent with the approved Imfinzi dosing in extensive-stage small cell lung cancer (ES-SCLC) and will be available to patients weighing more than 30 kg as an alternative to the approved weight-based dosing of 10 mg/kg every 2 weeks. Durvalumab is approved in the U.S. in combination with etoposide and carboplatin or cisplatin as first-line treatment of patients with ES-SCLC based on the results of the phase lll CASPIAN trial. The FDA recommended that durvalumab be administered prior to chemotherapy at 1,500 mg every 3 weeks and then after the four cycles of chemotherapy, given every 4 weeks at 1,500 mg as single-agent maintenance.

In the CASPIAN trial, durvalumab was administered at 1,500 mg plus four cycles of platinum-etoposide chemotherapy at 80 to 100 mg/m2 of etoposide administered on Days 1 to 3 and investigator’s choice of carboplatin at area under the curve 5 to 6 mg/mL per min or 75 to 80 mg/m2 of cisplatin administered on Day 1 of each cycle. A maintenance dose of durvalumab was then administered at 1,500 mg every 4 weeks. The trial met its primary endpoint of enhanced overall survival (OS) with the addition of durvalumab compared with platinum-etoposide alone for six cycles with an average OS of 13.0 versus 10.3 months (HR, 0.73; 95% CI, 0.59-0.91; P = .0047). At 18 months, 34% of patients in the durvalumab arm were still living compared with 25% in the chemotherapy-alone arm.

In the press release, Victoria M. Villaflor, MD, clinical professor in the Department of Medical Oncology and Therapeutics Research at City of Hope Cancer Center, Los Angeles, California, stated, “This new four-week dosing option gives doctors the choice to cut the number of visits for critical cancer treatment in half and offers a regimen that is more convenient for patients. Additionally, it limits potential exposure to infection in the healthcare environment for a population that is especially vulnerable to complications from COVID-19.”

The manufacturer indicates that the new regimen is also consistent with the approved dosing of durvalumab for the first-line treatment of adult patients with extensive-stage small cell lung cancer, in combination with etoposide and either carboplatin or cisplatin. The most adverse effects associated with the use of Imfinzi for patients with (≥20% of patients with unresectable, stage III NSCLC) were cough, fatigue, pneumonitis/radiation pneumonitis, upper respiratory tract infections, dyspnea, and rash. The most common adverse reactions (≥ 20% of patients with extensive-stage SCLC) were nausea, fatigue/asthenia, and alopecia.
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