Business
BeyondSpring Announces Data & Safety Monitoring Board Recommendation for Plinabulin to Continue NSCLC Phase 3 Dublin-3 Study Without Modification
- DSMB Reviewed Over 500 Patients’ Data in Second Interim Analysis to Assess Overall Benefit / Risk with Plinabulin in Second- and Third-Line, EGFR Wild-Type
About this update from Beyondspring, Inc.
[{"type":"text","content":"- DSMB Reviewed Over 500 Patients’ Data in Second Interim Analysis to Assess Overall Benefit / Risk with Plinabulin in Second- and Third-Line, EGFR Wild-Type NSCLC -\n - Data Continue to Support Plinabulin’s Immune Mechanism-Targeted Patient Selection - NEW YORK, June 03, 2020 (GLOBE NEWSWIRE) -- BeyondSpring (the “Company” or “BeyondSpring”) (NASDAQ: BYSI), a global biopharmaceutical company focused on the development of innovative immuno-oncology cancer therapies, today announced that the Company has reached the second interim analysis for its Phase 3 Dublin-3 (Study 103) in the treatment of non-small cell lung cancer (NSCLC) with lead asset, Plinabulin. Upon reviewing the safety and efficacy data of over 500 patients and approximately 300 pre-specified death events, the Data & Safety Monitoring Board (DSMB) has advised BeyondSpring to continue the study without any modifications. Study 103 evaluates the anti-cancer effects of Plinabulin in combination with docetaxel, compared to docetaxel alone, in second- / third-line Epidermal Growth Factor Receptor (EGFR) wild-type NSCLC patients, with a primary endpoint of overall survival (OS). EGFR wild-type NSCLC patients make up 85 percent of the NSCLC population; second- / third- line NSCLC with EGFR wild-type represents one of the most significant clinical challenges with limited treatment options. Currently approved I/O therapies and the chemotherapy pemetrexed have advanced to first-line treatment, leaving a therapeutic void for patients whose cancer progresses. The remaining approved two chemotherapy options, docetaxel and the docetaxel-ramucirumab combination, have significant limitations. These limitations force second- / third-line patients to choose between minimal gains in OS (less than 1.5 months for docetaxel-ramucirumab) over docetaxel alone with extremely high severe (Grades 3 and 4) neutropenia rates at over 40 percent with both options. The onslaught of COVID-19 is causing oncologists to reconsider the impact of neutropenia on cancer care. Recent studies indicate that the death rate for NSCLC patients afflicted with COVID-19 are as high as 55 percent1 in the New York healthcare system, making the avoidance of neutropenia, as well as OS extension, the key priorities in cancer care. In a Phase 2 clinical trial, the Plinabulin-docetaxel combination demonstrated the effica...