The phase 3 PROTECTIVE-2 (Study 106) trial met its primary and secondary end points in preventing chemotherapy-induced neutropenia following treatment with plinabulin in combination with pegfilgrastim.
The combination use of plinabulin with pegfilgrastim (Neulasta), compared with pegfilgrastim alone, significantly improved the rate of grade 4 chemotherapy-induced neutropenia (CIN) prevention, according to a pre-specified interim analysis of the phase 3 PROTECTIVE-2 (Study 106) trial.
“We are extremely excited about the topline results from the interim analysis of PROTECTIVE-2 phase 3. With these breakthrough data, coupled with the consistent data generated across our 6 independent clinical trials on over 1,200 patients, we aim to cover new ground in developing a treatment that prevents severe neutropenia, instead of just merely reducing it, as with the current standard of care,” Lan Huang, PhD, CEO and co-Founder of BeyondSpring – the agent’s manufacturer – said in a press release.
The double-blind, active controlled, global phase 3 PROTECTIVE-2 study – which accrued approximately 120 patients in the pre-specified interim analysis – met its primary end point of improving the rate of severe CIN prevention in the first chemotherapy cycle (P < .01) with plinabulin in combination with pegfilgrastim, compared with the current standard of care alone.
Moreover, the trial met its key secondary end points of the duration of severe CIN during cycle 1 of chemotherapy (P < .05), and duration of severe CIN in the first 8 days of cycle 1 (P < .05), “supporting plinabulin’s mechanism of action in providing early protection against severe neutropenia, as Neulasta alone is known to protect against severe neutropenia typically from day 9 onward,” a BeyondSpring stated in the release. “Therefore, the complementary mechanism would potentially give full protection in cycle 1.”
Douglas Blayney, MD, professor of medicine at Stanford Medical School and global principal investigator of plinabulin’s CIN studies, noted that the combination logically provides significantly better protection.
“Since most infections, hospitalizations and other complications of CIN occur in the first week after chemotherapy, it is particularly gratifying to see the combination’s clinical benefit demonstrated. These results could help to confirm the patient benefit of Plinabulin’s different mechanism of action from the G-CSF-based agents, such as Neulasta,” he said in the press release. “…We are well on our way to confirming that the combination offers protection throughout the chemotherapy cycle, which is an unmet medical need.”
The company noted that procedures are in place to prevent potential bias after the planned interim analysis.
“This interim result shows Plinabulin-Neulasta combination’s potential for the first superior therapy and significant enhancement to G-CSF in preventing neutropenia in the last 30 years,” Huang said. “Today’s announcement marks the results of years of hard work and a significant step in fulfilling our mission. In the COVID-19 pandemic, the ability to reduce severe neutropenia, which is directly linked to both infections and hospitalizations, has become increasingly important for immune-compromised cancer patients. We have a unique opportunity to potentially bring this innovative therapy to the patients with unmet medical needs.”
BeyondSpring. BeyondSpring Announces Positive Topline Interim Results from PROTECTIVE-2 (Study 106) Phase 3 Trial Evaluating Superiority of Plinabulin in Combination with Neulasta for Chemotherapy-Induced Neutropenia Prevention. Published June 15, 2020. https://www.beyondspringpharma.com/pressreleases/info.aspx?itemid=3224. Accessed June 15, 2020.