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Topline results from the phase 3 PROTECTIVE-2 study demonstrated that plinabulin in combination with Neulasta (pegfilgrastim) significantly improved the prevention of chemotherapy-induced neutropenia, compared to the standard of care alone.
In topline findings from the phase 3 PROTECTIVE-2 trial announced on Monday by BeyondSpring, plinabulin in combination with the current standard of care, Neulasta (pegfilgrastim), significantly improved the prevention of chemotherapy-induced neutropenia (CIN), compared with Neulasta alone.
“We are pleased to have received breakthrough therapy designation from both the U.S. (Food and Drug Administration) and China NMPA for the plinabulin combination in CIN, underscoring the unmet medical need and potential benefit of the combination,” said BeyondSpring’s chief medical officer and executive vice president of research and development Dr. Ramon Mohanlal in a press release. “We are working with regulatory agencies on the (new drug application) submission, which is expected in (the first quarter of) 2021 and have also begun preparation for commercialization.”
The double-blind, active controlled, global phase 3 trial comprised 221 patients, 111 of which received the combination. Patients who received the combination achieved a prevention rate of grade 4 neutropenia of 31.5% versus 13.6% in those who received Neulasta alone.
Moreover, patients who received the combination were less likely (58.6%) to report grade 4 side effects than those who received Neulasta alone (80%).
“These data clearly demonstrate the potential for this combination to offer superior therapy compared to standard of care in the prevention of (chemotherapy-induced neutropenia),” said Dr. Douglas Blayney, professor of medicine at Stanford Medical School and global principal investigator of plinabulin’s chemotherapy-induced neutropenia studies, in the release.
He thanked the patients who participated in the trial for their help in developing a treatment that could help prevent chemotherapy-induced neutropenia.
“With current therapy, grade 4 neutropenia still occurs in more than 80% of patients after chemotherapy, primarily in week 1 after chemotherapy, which increases emergency room visits and hospitalizations due to infection and febrile neutropenia,” Blayney said. “Grade 4 neutropenia is also associated with increased mortality and reduced long-term survival due to reduction, delay, or interruption of chemotherapy.”
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