A less-frequent, fixed dose regimen of Imfinzi (durvalumab) has been approved in the European Union and U.K. to treat adults with locally advanced, inoperable non-small cell lung cancer (NSCLC), announced the therapy’s developer, AstraZeneca.
This new dosing option, which will reduce the need for medical appointments, will be available to NSCLC patients weighing more than 30 kg (about 66 pounds), whose disease has not progressed following platinum-based chemoradiation therapy, and whose tumors have at least 1% of cells producing the PD-L1 protein.
Imfinzi’s new dosing regimen, which had also been approved in Europe and other regions to treat those with extensive-stage small cell lung cancer (ES-SCLC), will allow the medication to be given at a fixed dose of 1,500 mg every four weeks to treat NSCLC patients.
This will be available as an alternative to therapy’s original weight-based dosing of 10 mg/kg every two weeks that had previously been approved for the same indication.
“We are pleased to offer a four-week dosing option to lung cancer patients in Europe to meet an urgent need and help enable continuity of care during the pandemic,” Dave Fredrickson, executive vice president of AstraZeneca’s oncology business unit, said in a press release. “Cancer won’t wait, and it is our job to provide patients with treatment options that address the challenges the pandemic poses to their care.”
The European Commission’s decision to approve Imfinzi’s new dosing regimen was announced a month after the Committee for Medicinal Products for Human Use, a branch of the European Medicines Agency, recommended its approval. This recommendation and subsequent approval also applied to the U.K.
Last year, the U.S. Food and Drug Administration also approved the same regimen of Imfinzi to treat patients with locally advanced, inoperable NSCLC, as well as those with advanced bladder cancer.
The approvals of the new regimen were supported by data from several trials, including the CASPIAN Phase 3 trial (NCT03043872), in which the regimen was given to ES-SCLC patients, and the PACIFIC Phase 3 trial (NCT02125461), where the therapy’s original two-week regimen was used to treat those with advanced NSCLC.
“Less-frequent dosing is important for cancer patients, and may be particularly relevant right now for those suffering from lung cancer, who are especially vulnerable to complications from COVID-19,” said Luis Paz-Ares, MD, PhD, principal investigator in the CASPIAN trial.
“Doctors can now offer them a more convenient dosing option that could reduce medical visits by half and help avoid unnecessary risk of exposure to infection in the healthcare setting,” added Paz-Ares, who is also chair of the medical oncology department at the Hospital Universitario Doce de Octubre in Spain.
Imfinzi is an immune checkpoint inhibitor that works by blocking PD-L1, a protein produced by cancer cells to avoid being targeted and eliminated by immune cells. By inhibiting PD-L1, Imfinzi is expected to increase the immune system’s effectiveness at recognizing and destroying malignant cancer cells.
In addition to lung cancer, Imfinzi is being investigated as a potential treatment for other cancers, including liver, esophageal, gastric, cervical, and ovarian cancer, when given alone or in combination with other therapies.
