BeyondSpring Pharmaceuticals, Inc., a clinical stage biopharmaceutical company focused on the development of innovative cancer therapies, today announced that it plans to initiate a Phase 3 pivotal trial of lead product candidate, Plinabulin, in patients with non-small cell lung cancer (NSCLC) in the first quarter of 2015. The planned initiation of the Phase 3 trial follows the presentation of positive data from a Phase 2 clinical trial evaluating Plinabulin at the 50th American Society of Clinical Oncology (ASCO) Annual Meeting, held on May 30 -June 3, 2014 in Chicago, Illinois.
Plinabulin is an anti-cancer agent with a unique mechanism of action. It has multi-faceted activities that have been shown to exhibit anti-tumor activity through anti-angiogenesis, obliteration of existing tumor vasculature and induction of tumor cell apoptosis via the JNK pathway.
The completed Phase 1b/2, open-label trial (NCT00630110) in patients with advanced (Stage 3b/4) NSCLC compared the efficacy and safety of the combination of Plinabulin and docetaxel to docetaxel alone. Results of the trial were presented in a poster titled “Randomized phase 2 trial of plinabulin (NPI-2358) plus docetaxel in patients with advanced non-small cell lung cancer (NSCLC),” (Abstract #8054) during a general poster session on “Lung Cancer – Non-Small Cell Metastatic”
Dr. Lan Huang, Ph.D., Chief Executive Officer of BeyondSpring Pharmaceuticals, commented, “The data from our Phase 2 study validated Plinabulin’s unique mechanism of action and allowed us to tailor our next trial using a unique biomarker-driven approach to patients who will be most likely to benefit from treatment with Plinabulin, such as those with large lung cancer lesions, and thus more dependent on the abundant tumor vasculature. Our Phase 2 study demonstrated a longer median overall survival for this particular subset of patients – 11.5 months for combination Plinabulin plus docetaxel compared to just 7.8 months for patients receiving docetaxel alone. This is a substantial improvement compared to approved lung cancer drugs which, in pivotal trials, demonstrated overall survival of approximately 8 months. Furthermore, over the last 15 years, few drugs have received FDA approval specifically for second-line NSCLC with EGFR and ALK wild type patients, who typically have much shorter survival time than EGFR and ALK mutant patients. Given this, there is a critical unmet medical need for NSCLC patients without EGFR or ALK mutations. Our data have shown that Plinabulin activities are independent of EGFR, ALK mutations. We believe Plinabulin would be an important addition to the armamentarium for this difficult to treat disease.”
In the Phase 2 portion of this study, a total of 172 patients with NSCLC who had progressed after at least one chemotherapy regimen for advanced disease were randomized 1:1 to receive docetaxel alone (75 mg/m2) or docetaxel (75 mg/m2) in combination with either Plinabulin at 30 mg/m2 (30 Cohort) or 20 mg/m2 (20 Cohort). A total of 163 patients were treated. The primary endpoint was overall survival (OS), with secondary endpoints including progression-free survival (PFS), objective response rate (ORR), duration of response (DOR) and safety. The study also aimed to identify, on an exploratory basis, a subset of patients that responds better to combination therapy of Plinabulin and docetaxel.