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Spectrum cancer drug fails in study; blood disorder therapy up for FDA review

Spectrum Pharmaceuticals Inc.'s experimental drug poziotinib failed to meet the main goal of reducing the extent of a type of lung cancer in certain patients taking part in a mid-stage study.

Together, Spectrum's blood disorder drug Rolontis — the biologics license application for which has been accepted by the U.S. Food and Drug Administration — and poziotinib make up the late-stage assets the company planned to focus on after India-based Aurobindo acquired seven of its cancer drugs in March.

The Zenith20 trial evaluated poziotinib in 115 heavily pretreated patients with non-small cell lung cancer, or NSCLC, having EGFR exon 20 insertion mutations.

According to results from the study, 17 of the patients responded to the medicine, while 62 patients' disease remained stable. Only 14.8% of the patients saw a reduction in their lung cancer.

The patients make up the first of seven total groups to be evaluated in the study. While the company is disappointed in the medicine's effectiveness in the first group, "positive signals observed" in the study make the company hopeful for the therapy in the next two groups of patients, President and CEO Joe Turgeon said, adding that results for these groups are expected in 2020.

Spectrum is seeking FDA approval for Rolontis, or eflapegrastim, to treat chemotherapy-induced neutropenia, an abnormally low concentration of white blood cells called neutrophils, due to chemotherapy.

The FDA expects to take action on the Rolontis application by Oct. 24, 2020.

Spectrum said the application for Rolontis is supported by results from two phase 3 studies dubbed Advance and Recover, which showed that Rolontis and Amgen Inc.'s Neulasta, or pegfilgrastim, had no meaningful differences.