- 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 -
- 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 efficacy benefit of a long duration of response (12.7 months) and a median OS benefit of 4.6 months (retrospective analysis in the measurable lung lesion subset) over docetaxel, the standard of care, alone. Most importantly, in that study, adding Plinabulin to docetaxel reduced the frequency of patients who experienced Grade 4 neutropenia from 33.8 percent to less than 5 percent (p