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BeyondSpring Announces First Patient Dosed in a Triple Combination Study with Plinabulin, PD-1/PD-L1 Inhibitor and Radiotherapy for the Reversal of Resistance to PD-1/PD-L1 Inhibitors in Patients with Advanced Solid Tumors
Resistance to immunotherapy is a severe unmet medical need that plinabulin aims to address in combination with checkpoint inhibitors and radiotherapyFirst
About this update from Beyondspring, Inc.
[{"type":"text","content":"Resistance to immunotherapy is a severe unmet medical need that plinabulin aims to address in combination with checkpoint inhibitors and radiotherapyFirst patient who failed Keytruda and chemotherapy has been dosed with plinabulin, Keytruda and radiation combination in non-small cell lung cancer (NSCLC) NEW YORK, June 04, 2021 (GLOBE NEWSWIRE) -- BeyondSpring (the “Company” or “BeyondSpring”) (NASDAQ: BYSI), a global biopharmaceutical company focused on the development of innovative cancer therapies, today announced that the first patient had been dosed in the Phase 1b/2 investigator-initiated trial, studying the safety and tolerability of plinabulin, in triple combination therapy with both PD-1/PD-L1 antibody (mAb) and radiation therapy (RT). This triple combination is actively recruiting at The University of Texas MD Anderson Cancer Center, with Dr. Vivek Subbiah as principal investigator, in seven metastatic or locally advanced cancers, which include bladder cancer, melanoma, Merkel cell cancer, MSI-H cancers (of any histology), non-small cell lung cancer (NSCLC), renal cell cancer, and small cell lung cancer (SCLC). The study is titled “An Open-label, Single-center, Phase 1b/2 Study to Evaluate the Safety of Plinabulin in Combination with Radiation/Immunotherapy in Patients with Select Advanced Malignancies after progression on PD-1 or PD-L1 Targeted Antibodies.” Patients will receive a triple combo treatment of RT + plinabulin + anti-PD-1/PD-L1 mAb in Cycle 1, followed by anti-PD-1/PD-L1 mAb and plinabulin combo regimen in Cycle 2 and beyond until disease progression or development of unacceptable toxicity, withdrawal from study treatment, or discontinuation of this study.Plinabulin will be tested in combination with five different PD-1/PD-L1 immunotherapies (avelumab, durvalumab, nivolumab, atezolizumab and pembrolizumab) and the exact dosing and treatment schedule will be determined by treatment cycle for each immunotherapy agent.The first patient progressed on Keytruda and chemotherapy in first-line NSCLC, and has been dosed with RT, plinabulin (30 mg/m2) and Keytruda. Plinabulin, a selective immunomodulating microtubule-binding agent (SIMBA), induces maturation of dendritic cells (antigen-presenting cells or APCs) resulting in the activation of tumor antigen-specific T-cells to selectively target cancer cells. It has be...