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BeyondSpring Presents Promising Data for Lead Asset Plinabulin at 2018 ASCO-SITC Clinical Immuno-Oncology Symposium
Plinabulin and Neulasta have Very Similar Grade 4 Neutropenia Incidence and Duration of Severe Neutropenia (DSN) in the Phase 2 Portion of Phase 2/3 Trial Study 105 with Docetaxel-Induced Neutropenia
Initial Phase 1 Results in Investigator-Initiated Trials Highlight Plinabulin’s Safety in Combination with Immuno-Oncology Agent Nivolumab
Study 105: Plinabulin-Docetaxel CIN Treatment
Patient enrollment in the Phase 2 portion has been completed. A total of N=55 patients with advanced or metastatic NSCLC were enrolled. Patients were randomly assigned to the following arms (with the respective sample sizes):
Arm 1: Docetaxel (Day 1, 75 mg/m2) + pegfilgrastim (Day 2, 6 mg) (N=14)
The topline data from the Phase 2 portion of Study 105 is summarized below. For grade 4 neutropenia and DSN, there is an apparent dose-response, favoring the 20 mg/m2 Plinabulin dose.
“This data is extremely promising for
Plinabulin is a non-G-CSF agent that prevents CIN through a mechanism different from G-CSF by sustaining neutrophil levels within the normal range via reversal of the block of neutrophil formation in the bone marrow induced by docetaxel. Plinabulin had been shown to prevent neutropenia caused by a number of chemotherapeutics with different anti-tumor mechanisms in preclinical studies.
Triple Immuno-Oncology Strategy
Plinabulin appears to be a PDE4-inhibitor at clinically relevant doses. PDE4-inhibitors are potent anti-inflammatory agents that are approved to date to treat inflammatory disorders like eczema, psoriasis and chronic obstructive pulmonary disease (COPD), with resemblance to immune-related adverse events (IR-AEs) as observed with checkpoint inhibitors.
In the two Phase 1 studies with NSCLC patients, a total of 10 patients have been enrolled to date and received Nivolumab (240 mg or 3 mg/kg) in combination with Plinabulin at 13.5 mg/m2 (N=3), 20 mg/m2 (N=5) or ~30 mg/m2 (N=2). The data shows that no grade 3/4 IR-AEs were observed. Two patients had developed either grade 1 or 2 IR-AEs without the need for steroid treatment.
The Company also presents non-clinical and preliminary clinical data to demonstrate Plinabulin’s immune-enhancing effects, resulting in improved anticancer efficacy compared to checkpoint inhibitors or chemotherapy alone. Plinabulin exerts immune-enhancing effects through the activation of dendritic cells and the antigen-specific proliferation of T-cells.
Plinabulin in combination with docetaxel significantly (P<0.05) prolonged the DoR in NSCLC patients, compared to docetaxel alone in a Phase 2 study (Study 101).
In the immune-competent MC38 animal model, the triple combination of Plinabulin and PD-1 and CTLA-4 antibodies showed around four times more tumor inhibition compared to PD-1 antibodies alone, while the combination of Plinabulin and PD-1 antibodies showed around two times more tumor inhibition compared to PD-1 antibodies alone.
“Preliminary clinical data suggests that the addition of Plinabulin to checkpoint inhibitor therapy would prevent IR-AEs,” added Dr.
“We are highly encouraged with the steady flow of data that is being generated with Plinabulin, which provides strong justification for advancing Plinabulin as a platform drug toward commercialization in multiple indications,” concluded Dr.
As previously communicated,
A live webcast of the call will also be available online, which can be accessed through the Investor Relations section of BeyondSpring’s website: http://ir.beyondspringpharma.com. Please allow extra time prior to the call to visit the site and download any necessary software to listen to the live broadcast.
For interested individuals who are unable to join the conference call, a replay of the call will be available through
Cautionary Note Regarding Forward-Looking Statements