An Open-Label, Single-Arm, Phase II Study of Pembrolizumab, Plinabulin Plus Etoposide and Platinum as First-Line Therapy for Extensive-Stage Small-Cell Lung Cancer

Monoclonal antibodies against programmed death 1 (PD-1) and its ligand PD-L1 have shown efficacy in patients with ES-SCLC in the monotherapy and combination therapy settings. Up to now, Atezolizumab and Durvalumab has been approved for first line treatment for ES-SCLC in China combined with EP or EC. Besides, KEYNOTE-604 study revealed that adding pembrolizumab to standard first-line EP significantly improves PFS in patients with ES-SCLC and is associated with durable responses in a subset of patients. 12-m PFS rate were 13.6% with pembrolizumab plus EP and 3.1% with placebo plus EP. The statistical threshold for declaring significant prolongation of OS was narrowly missed. Considering sicker pts was enrolled and the interim analysis was quite often, even though the investigators narrowly missed the OS endpoint, longer numerical OS data was observed. The latest version of NCCN SCLC guidelines still recommended pembrolizumab as an option for ES-SCLC patients.
Plinabulin received breakthrough designation from both US and China FDA for CIN (Chemotherapy Induced Neutropenia) prevention indication. As a "pipeline in a drug," plinabulin is being broadly studied in combination with various immuno-oncology agents that could boost the effects of the PD-1/PD-L1 antibodies and re-sensitize PD-1/PD-L1 antibody resistant patients. In a poster released at 2021 ASCO conference, a phase I trial of Plinabulin in combination with nivolumab and ipilimumab in patients with relapsed small cell lung cancer: Big Ten Center Research Consortium (BTCRC-LUN17-127) study. Plinabulin in combination with nivolumab and ipilimumab was safe and well tolerated with promising efficacy signal of 46% ORR.
From above, Pembrolizumab, Plinabulin plus Etoposide and Platinum as First-Line Therapy for ES-SCLC should be a promising combination therapy, as the investigators expect increased efficacy and reduced toxicity with the addition of Plinabulin. In this proof of concept phase II study, the investigators will investigate that the efficacy and safety of Pembrolizumab, Plinabulin plus Etoposide and Platinum as First-Line Therapy for ES-SCLC.

Start Date01 Nov 2023

Sponsor / Collaborator

Wuhan Union Hospital

NCT05599789 / RecruitingPhase 2IIT

A Phase 2 Study of Pembrolizumab in Combination With Plinabulin and Docetaxel in Previously Treated Patients With Metastatic Non-Small Cell Lung Cancer and Progressive Disease (PD) After Immunotherapy (Anti-PD-1/PD-L1 Inhibitor) Alone or in Combination With Platinum-doublet Chemotherapy (KeyPemls-004)

A Phase 2 Study of Pembrolizumab in Combination with Plinabulin and Docetaxel in previously treated Patients with Metastatic Non-Small Cell Lung Cancer and progressive disease (PD) after immunotherapy (Anti-PD-1/PD-L1 inhibitor) alone or in combination with Platinum-doublet Chemotherapy.

Start Date01 Feb 2023

Sponsor / Collaborator

Peking Union Medical College Hospital

[+2]

NCT05130827 / Active, not recruitingPhase 2IIT

Pilot Trial of Plinabulin and Pegfilgrastim to Reduce the Duration of Absolute Neutropenia After Autologous Hematopoietic Cell Transplantation for Patients With Multiple Myeloma

This study will see how long it takes for white blood cell counts to return to normal in people with multiple myeloma (MM) who receive plinabulin and pegfilgrastim after undergoing an autologous hematopoietic stem cell transplant (AHCT).

Start Date21 Dec 2021

Sponsor / Collaborator

Memorial Sloan Kettering Cancer Center

[+1]

100 Clinical Results associated with Plinabulin

100 Translational Medicine associated with Plinabulin

100 Patents (Medical) associated with Plinabulin

Literatures (Medical) associated with Plinabulin

01 Oct 2024·The Lancet Respiratory Medicine

Plinabulin plus docetaxel versus docetaxel in patients with non-small-cell lung cancer after disease progression on platinum-based regimen (DUBLIN-3): a phase 3, international, multicentre, single-blind, parallel group, randomised controlled trial

Article

Author: Cheng, Ying ; Luo, Feng ; Han, Baohui ; Jie, Zhijun ; Shi, Jianhua ; Guo, Qi-Sen ; Nagrial, Adnan ; Wang, Huaqing ; Huang, Lan ; Feng, Jifeng ; Guo, Qi-sen ; Kloecker, Goetz ; Ye, Feng ; Bazhenova, Lyudmila ; Zhao, Jun ; Oliff, Ira A ; Yao, Yu ; Li, Helen ; Oliff, Ira ; Hu, Chunhong ; Kiberu, Andrew ; Mowat, Rex B ; Liu, Chunling ; Du, Lihua ; Zhang, Yiping ; Wang, Zhongkun ; Cheng, Gongyan ; Pan, Hongming ; Jennens, Ross ; Jain, Vikram ; Liu, Zhihua ; Wu, Huijuan ; Lu, Junguo ; Hrom, John S ; Karim, Nagla A ; Wu, Yanping ; Huang, Chao Hui ; Lloyd, Ken ; Ruiz, Jimmy ; Jiang, Da ; Shi, Yuankai ; Zhang, Liangming ; Cao, Lejie ; Liu, Bin ; Sun, Yan ; Chen, Gongyan ; Sujith, Kalmadi R ; Zhou, Jian-ying ; Kalmadi, R Sujith ; Mao, Weidong ; Wong, Matthew ; Feinstein, Trevor ; Kloecker, Goetz H ; Li, Xiaoling ; Shunyakov, Leonid V ; Thara, Eddie

BACKGROUNDThere is an unmet need for second-line and third-line treatments that are effective and tolerable for advanced or metastatic non-small-cell lung cancer (NSCLC) with no driver mutations.METHODSIn this phase 3, international, multicentre, single-blind, parallel group, randomised controlled trial, we enrolled patients from 58 medical centres in Australia, China, and the USA. Eligible patients were adults with epidermal growth factor receptor (EGFR) wild-type NSCLC who had progressed after first-line platinum-based therapy. Patients were randomly assigned (1:1) using an independent stratified randomisation schedule with a block size of four to receive intravenous docetaxel 75 mg/m² on day 1 and either plinabulin (30 mg/m²) or placebo on days 1 and 8 in 21-day cycles until progression, unacceptable toxic effects, withdrawal, or death. The primary endpoint was overall survival (OS) in the intention-to-treat (ITT) population. Safety was analysed in all patients who had received at least one dose of study drug or placebo. This trial is registered with ClinicalTrials.gov (NCT02504489) and is now closed.FINDINGSBetween Nov 30, 2015, and Jan 6, 2021, 919 patients were screened for inclusion. 360 patients were excluded, and 559 were enrolled and randomly assigned to receive either docetaxel and plinabulin (n=278) or docetaxel and placebo (n=281). 406 (73%) of 559 patients were male, 153 (27%) were female, and 488 (87%) were Asian. Median OS was 10·5 months (95% CI 9·34-11·87) in the plinabulin group compared with 9·4 months (8·38-10·68) in the control group (stratified HR 0·82, 95% CI 0·68-0·99; p=0·0399). Mean OS was 15·08 months (13·42-16·74) in the plinabulin group compared with 12·77 months (11·45-14·10) in the placebo group using restricted mean survival time analysis (difference 2·31 months, 95% CI 0·18-4·44; p=0·0332). Treatment-emergent adverse events occurred in 273 (>99%) of 274 patients in the plinabulin group and 276 (99%) of 278 patients in the control group. Grade 3 or 4 gastrointestinal disorders occurred more frequently in the plinabulin group than in the placebo group, with the most frequent being diarrhoea (24 [9%] of 274 patients vs three [1%] of 278) and vomiting (six [2%] vs one [<1%]), as did transient grade 3 hypertension (50 [18%] vs eight [3%]). Treatment-emergent death was reported in 12 patients (4%) in the plinabulin group and ten patients (4%) in the placebo group.INTERPRETATIONPlinabulin plus docetaxel significantly improved OS as second-line and third-line treatment in patients with advanced or metastatic EGFR wild-type NSCLC and could be considered as a new treatment option in this population.FUNDINGBeyondSpring Pharmaceuticals.

01 Oct 2024·The Lancet Respiratory Medicine

Plinabulin, a microtubule destabilising agent, in non-small-cell lung cancer: lessons from the DUBLIN-3 trial

Article

Author: Molina-Vila, Miguel Angel ; González-Cao, María ; Rosell, Rafael

01 Sep 2024·Biomaterials

Co-delivery of Plinabulin and Tirapazamine boosts anti-tumor efficacy by simultaneously destroying tumor blood vessels and killing tumor cells

Article

Author: Yu, Haiyang ; Sakurai, Kazuo ; Lv, Jianlin ; Xu, Yajun ; Liu, Ya ; Tang, Zhaohui

It is imperative to optimize chemotherapy for heightened anti-tumor therapeutic efficacy. Unrestrained tumor cell proliferation and sustained angiogenesis are pivotal for cancer progression. Plinabulin, a vascular disrupting agent, selectively destroys tumor blood vessels. Tirapazamine (TPZ), a hypoxia-activated prodrug, intensifies cytotoxicity in diminishing oxygen levels within tumor cells. Despite completing Phase III clinical trials, both agents exhibited modest treatment efficiency due to dose-limiting toxicity. In this study, we employed methoxy poly(ethylene glycol)-b-poly(_D,_L-lactide) (mPEG-b-PDLLA) to co-deliver Plinabulin and TPZ to the tumor site, concurrently disrupting blood vessels and eliminating tumor cells, addressing both symptoms and the root cause of tumor progression. Plinabulin was converted into a prodrug with esterase response (PSM), and TPZ was synthesized into a hexyl chain-containing derivative (TPZHex) for effective co-delivery. PSM and TPZHex were co-encapsulated with mPEG-b-PDLLA, forming nanodrugs (PT-NPs). At the tumor site, PT-NPs responded to esterase overexpression, releasing Plinabulin, disrupting blood vessels, and causing nutritional and oxygen deficiency. TPZHex was activated in response to increased hypoxia, killing tumor cells. In treating 4T1 tumors, PT-NPs demonstrated enhanced therapeutic efficacy, achieving a 92.9 % tumor suppression rate and a 20 % cure rate. This research presented an innovative strategy to enhance synergistic efficacy and reduce toxicity in combination chemotherapy.

News (Medical) associated with Plinabulin

16 Sep 2024

·www.globenewswire.com

BeyondSpring Presents Efficacy/Safety Results from a Phase 2 Study of Pembrolizumab plus Plinabulin/Docetaxel in Metastatic NSCLC after Progressing on First-Line Immune Checkpoint Inhibitors at ESMO Congress 2024

Median PFS at 8.63 months and Disease Control Rate of 89.5% in Previously Treated NSCLC Patients after Progression on PD-1/L1 Monotherapy or in Combination with Platinum Doublet ChemotherapyFLORHAM PARK, N.J., Sept. 16, 2024 (GLOBE NEWSWIRE) -- BeyondSpring Inc. (NASDAQ: BYSI) (“BeyondSpring” or the “Company”), a clinical-stage global biopharmaceutical company developing innovative cancer therapies, today presented interim phase 2 data on the 303 Study, a study in 2L/3L non-small cell lung cancer (NSCLC) after disease progression on 1L PD-1/L1 inhibitors with and without chemotherapy, with financial support from Merck & Co., Inc’s (NYSE: MRK, known as MSD outside of the United States and Canada) Investigator Studies Program and provision of study drug, at the European Society for Medical Oncology (ESMO) Congress 2024, on September 14, 2024 in Barcelona, Spain. Docetaxel remains the standard of care for patients with 2L/3L NSCLC without targetable alterations who progress on 1L immune checkpoint inhibitors (ICI) with and without standard chemotherapy, with an overall response rate (ORR) of 12.8% and median PFS (mPFS) of 3.7 months in TROPION Lung-01 phase 3 studies. In metastatic NSCLC resistant to previous PD-1/L1 therapy1, PD-L1 and CTLA-4 inhibition alone or in combination with hypofractionated radiotherapy produced limited clinical benefits with ~11.5% ORR. This investigator-initiated, single-arm, open-label, phase 2 study (KeyPelms-004 or 303 Study) evaluates the efficacy and safety of a triple combination regimen of pembrolizumab plus plinabulin/docetaxel (NCT05599789). The study intends to enroll a total of 47 patients and is ongoing at Peking Union Medical College Hospital, Beijing, China with the principal investigator Dr. Mengzhao Wang, Chief of the Department of Respiratory and Critical Care Medicine. Here, we report on a planned formal interim analysis of 19 patients. At the database lock on 29 April 2024, 29 patients were enrolled and 19 were evaluable for stage 1 data analysis. All patients experienced disease progression after initial clinical benefit with ICI. Of the 19 evaluable patients (median age at 66.4 years; ranged 50-76 years), 68.4% were male and 31.6% were female; 57.9% were current or former smokers. Histology included 57.9% patients with non-squamous cell carcinoma and 42.1% with squamous cell carcinoma. The median follow-up was 8.67 months. Below is an efficacy summary table. Primary Endpoint Plinabulin + Pembrolizumab + Docetaxel (n=19)Confirmed ORR (RECIST 1.1)21.1% Secondary Endpoints Median PFS (RECIST 1.1)8.63 M(6 M PFS rate: 67.1%;12 M PFS rate: 49.2%)Median OS (Overall Survival)Not reachedMedian DoR (Duration of Response)11.40 MDisease Control Rate(PR + SD > 4 months)89.5% The combination was well tolerated. 52.6% of patients experienced grade 3 or higher treatment-related adverse effects. There were no treatment-related deaths. “Plinabulin is a potent inducer of dendritic cell or DC maturation that leads to T cell activation. DC is the most potent antigen presenting cell (APC). This unique mechanism of action reinforces anti-tumor immune response with the potential to overcome acquired ICI resistance, which may derive from APC pathway mutation or T cell exhaustion. Compared to historical controls of 3-4 months of median PFS2, this study’s early efficacy data doubled median PFS to 8.6 months, with an impressive disease control rate of almost 90%, which is encouraging and clinically meaningful for this severe unmet need,” said Dr. Mengzhao Wang, principal investigator at Peking Union Medical College Hospital. ESMO Congress 2024 (1330P): Phase 2 Study of Pembrolizumab plus Plinabulin and Docetaxel for Patients (pts) with Metastatic NSCLC after Failure on First-line Immune Checkpoint Inhibitor Alone or Combination Therapy: Initial Efficacy and Safety Results on Immune Re-sensitization Presenter: Dr. Yan Xu, Peking Union Medical College Hospital, Beijing, ChinaPoster Session: NSCLC, metastatic References: Schoenfeld et al. 2022, Lancet Oncology 23:279-291TROPION Lung-01: https://doi.org/10.1200/JCO-24-01544 About PlinabulinPlinabulin is a novel first-in-class dendritic cell maturation therapeutic with durable anti-cancer benefit observed across multiple clinical studies. As a reversible binder at a distinct tubulin pocket, plinabulin does not change tubulin dynamics or antagonize tubulin stabilizing agents, such as docetaxel, which contributes to its differentiated activity and tolerability compared to other tubulin binders. In addition, plinabulin significantly reduces chemotherapy induced neutropenia and could thereby increase docetaxel tolerability. Over 700 patients have been treated with plinabulin with good tolerability. About KeyPelms-004 or 303 Study303 Study is an open-label, single-arm Phase 2 Study of Plinabulin plus docetaxel and pembrolizumab for previously treated patients with metastatic NSCLC and progressive disease after anti-PD-(L)1 inhibitor alone or in combination with platinum-doublet chemotherapy. This study evaluates the efficacy and safety of this triple combination and is being conducted at Peking Union Medical College Hospital, Beijing, China. The regimen includes Pembrolizumab 200 mg IV every 3 weeks (Q3W) on Day 1, Docetaxel 75 mg/m2 IV Q3W on Day 1 and Plinabulin 30mg/m2 IV Q3W on Day 1 in a 21-day cycle. The primary endpoint is investigator-based ORR (RECIST 1.1). The secondary endpoints include PFS, OS, DoR, and safety. The study intends to enroll 47 patients with a formal interim analysis of 19 patients enrolled. The study is funded by Merck’s Investigator Studies Program with provision of study drug and financial support.About BeyondSpringBeyondSpring is a global clinical-stage biopharmaceutical company developing innovative therapies to improve clinical outcomes for patients with high unmet medical needs. The Company is advancing its first-in-class lead asset, Plinabulin, a potent inducer of dendritic cell maturation, in late-stage clinical development as a direct anti-cancer agent in NSCLC and a variety of cancer indications. BeyondSpring’s pipeline also includes three preclinical immuno-oncology assets. Additionally, BeyondSpring is an equity owner of SEED Therapeutics, Inc which is a pioneer in Target Protein Degradation technology and its application in innovative drug development. Learn more by visiting https://beyondspringpharma.com. Investor Contact:IR@beyondspringpharma.com Media Contact:PR@beyondspringpharma.com

Clinical ResultPhase 2ImmunotherapyPhase 3

16 Sep 2024

·www.globenewswire.com

BeyondSpring Presents Final Data Analysis of DUBLIN-3 Phase 3 Study in 2L/3L EGFR Wild-type NSCLC at ESMO Congress 2024

Plinabulin/Docetaxel Combination Demonstrated Favorable Benefit/Risk Ratio over Docetaxel Alone: Significant Improvement in Overall Survival, Progression Free Survival, and Objective Response, with additional Significant Reduction of Grade 4 Neutropenia (>80% relative reduction), and Improved Patients’ Quality of LifeFLORHAM PARK, N.J., Sept. 16, 2024 (GLOBE NEWSWIRE) -- BeyondSpring Inc. (NASDAQ: BYSI) (“BeyondSpring” or the “Company”), a clinical-stage global biopharmaceutical company developing innovative cancer therapies, presented final data on Dublin-3 study (2L/3L EGFR wild-type NSCLC) focusing on safety outcomes on September 14, 2024 at European Society for Medical Oncology (ESMO) Congress 2024 in Barcelona, Spain. Full data on Dublin-3 study was published on September 9, 2024 in the Lancet Respiratory Medicine (https://doi.org/10.1016/S2213-2600(24)00178-4). Docetaxel remains the standard of care for patients with 2L/3L NSCLC without targetable alterations despite severe neutropenia (>40%) that greatly impair patients’ quality of life. Six recent phase 3 studies in patients with EGFR wild-type NSCLC who were previously treated with immune checkpoint inhibitors failed to show overall survival (OS) benefit compared with docetaxel (SAPPHIRE, LEAP-008, CONTACT01, EVOKE-01, CARMEN-LC03, and CANOPY-2). Two phase 3 studies (LUNAR and TROPION-Lung01) showed positive but mixed outcomes compared with docetaxel. The DUBLIN-3 study was a multicenter, single-blinded, randomized controlled trial that enrolled patients from 58 medical centers across Australia, China, and the USA. 559 patients with epidermal growth factor receptor (EGFR) wild-type NSCLC were randomly assigned (1:1) to receive either docetaxel and plinabulin (n=278) or docetaxel and placebo (n=281). The plinabulin/docetaxel combination significantly improved overall survival (OS), progression-free survival (PFS), and objective response rate (ORR) compared to docetaxel alone. (Click here for related press release.) This poster presentation focused on plinabulin and docetaxel combination safety vs. docetaxel alone, as shown below: The combination is well tolerated: Similar percentages of patients experienced ≥1TEAE (treatment emergent adverse events); 99.6% in the combination arm and 99.3% in the docetaxel arm. There was less grade 4 TEAE in the combination arm (19.0%) vs. 42.8% in the docetaxel arm.The combination had >80% relative reduction in Grade 4 neutropenia (p<0.001): The combination arm had a 5.3 % Grade 4 neutropenia in Cycle 1 Day 8 compared to 27.8% in docetaxel alone (81% reduction, p<0.0001). The combination arm had a 5.1 % Grade 4 neutropenia in all cycles Day 8 compared to 33.6% in docetaxel alone (85% reduction, p<0.0001). In addition, hospital admission due to febrile neutropenia was lower in the combination arm (7 [2.6%] patients) vs. docetaxel arm (14 [5.0%] patients).The combination had reduced use of granulocyte-colony stimulating factor (G-CSF) in all cycles: Post-hoc analysis showed reduced G-CSF use in the combination arm (152 [56%] patients) vs. docetaxel arm (182 [66%] patients) and at cycles 1 to 4.The combination had improved quality-of-life (QoL) based on Q-TWiST data: Exploratory analysis showed better QoL based on Q-TWiST in the combination arm, with a clinically meaningful relative gain to the docetaxel arm of 18.5%(p=0.0393).The combination had a significant reduction in cycle-adjusted serious adverse events (SAE): Patients randomized to the combination received more cycles of treatment. When cycles were adjusted for SAEs, plinabulin significantly decreased Grade 3/4 SAEs (p=0.0235) and Grade 4 SAEs (p<0.0001).The combination had manageable side effects: Plinabulin induced mostly asymptomatic transient hypertension, which mostly resolved within 4-6 hours after infusion without medication. In addition, plinabulin induced GI side effects, including nausea, vomiting, and diarrhea, which were effectively managed following a protocol adjustment to add the prophylactic use of antiemetics and increase time of infusion. “NSCLC patients without targetable alterations whose disease has progressed on previous platinum-based therapy have a poor prognosis. Docetaxel is the current standard of care with >40% severe neutropenia and poor quality of life. In second or third-line NSCLC patients with EGFR wild-type, the phase 3 data suggest that adding plinabulin to docetaxel has a favorable benefit/risk ratio compared to docetaxel alone in significantly improving anti-cancer efficacy, and significantly reducing severe neutropenia and improving quality of life. This combination could be considered as a new option for second or third-line NSCLC patients without driver mutation, which is a severe unmet medical need,” said Dr. Feinstein, one of the lead principal investigators of Dublin-3 study at Piedmont Cancer Center, Atlanta. ESMO Congress 2024 Presentation (1358P): Plinabulin/Docetaxel Versus Docetaxel in Survival Benefits of 2L/3L EGFR Wild-Type NSCLC after Platinum Regimens (DUBLIN-3): a Randomized Phase 3 Trial Presenter: Dr. Trevor M. FeinsteinPoster Session: NSCLC, metastatic Citation:Han B., et al. Plinabulin plus docetaxel versus docetaxel in patients with non-small-cell lung cancer after disease progression on platinum-based regimen (DUBLIN-3): a phase 3, international, multicentre, single-blind, parallel group, randomised controlled trial. Lancet Respir Med. 2024 Sep 09: S2213-2600(24)00178-4. About PlinabulinPlinabulin is a novel first-in-class dendritic cell (DC) maturation therapeutic with durable anti-cancer benefit observed across multiple clinical studies. As a reversible binder at a distinct tubulin pocket, plinabulin does not change tubulin dynamics or antagonize tubulin stabilizing agents, such as docetaxel, which contributes to its differentiated activity and tolerability compared to other tubulin binders. Importantly, clinical data suggests that plinabulin enhances the cancer immunity cycle when used sequentially with chemotherapy/radiation and a checkpoint inhibitor. In addition, plinabulin significantly reduces chemotherapy induced neutropenia and could thereby increase docetaxel tolerability. Over 700 patients have been treated with plinabulin with good tolerability. About Dublin-3 StudyDublin-3 NSCLC was a global phase 3 randomized, controlled clinical trial comparing the combination of plinabulin and docetaxel to an active control arm of docetaxel alone (1:1 randomization) in second- and third-line NSCLC patients who had failed platinum doublet therapies, and who were epidermal growth factor receptor (EGFR) wild-type. Docetaxel was given on Day 1 in both arms at 75 mg/m2 in each 21-day cycle. Plinabulin was given on Day 1, one hour after docetaxel, and on Day 8, both at 30 mg/m2 in each cycle. The primary endpoint for the study was OS, and secondary endpoints were PFS, ORR, Duration of Response (DoR), Grade 4 neutropenia and Quality of Life. About BeyondSpringBeyondSpring is a global clinical-stage biopharmaceutical company developing innovative therapies to improve clinical outcomes for patients with high unmet medical needs. The Company is advancing its first-in-class lead asset, plinabulin, a potent inducer of dendritic cell maturation, in late-stage clinical development as a direct anti-cancer agent in NSCLC and a variety of cancer indications. BeyondSpring’s pipeline also includes three preclinical immuno-oncology assets. Additionally, BeyondSpring is an equity owner of SEED Therapeutics, Inc which is a pioneer in Target Protein Degradation technology and its application in innovative drug development. Learn more by visiting https://beyondspringpharma.com. Investor Contact:IR@beyondspringpharma.com Media Contact:PR@beyondspringpharma.com

Clinical ResultPhase 3Immunotherapy

03 Sep 2024

·www.globenewswire.com

BeyondSpring Announces Oral Presentation at the 2024 World Conference on Lung Cancer and Two Poster Presentations During ESMO Congress 2024 Showcasing its Lead Anti-Cancer Asset, Plinabulin

FLORHAM PARK, N.J., Sept. 03, 2024 (GLOBE NEWSWIRE) -- BeyondSpring Inc. (NASDAQ: BYSI) (“BeyondSpring” or the “Company”), a clinical-stage global biopharmaceutical company focused on developing innovative cancer therapies, today announces that it will have an oral presentation on the final efficacy data of Plinabulin and docetaxel combination vs. docetaxel from Dublin-3 phase 3 study in EGFR wild-type 2L/3L non-small cell lung cancer (NSCLC) at the 2024 World Conference on Lung Cancer, on September 9, 2024 in San Diego, CA, and two poster presentations on Dublin-3 study safety outcome and 303 Study, the investigator-initiated study supported by Merck (known as MSD outside of the United States and Canada) in 2L/3L NSCLC who failed PD-1/PD-L1 inhibitors at European Society for Medical Oncology (ESMO) Congress 2024, on September 14, 2024 in Barcelona, Spain. Presentation details are as follows: 2024 World Conference on Lung CancerOral (OA08.04): Plinabulin/Docetaxel vs. Docetaxel in 2L/3L NSCLC after Platinum Regimens (DUBLIN-3): A Phase 3 Randomized Controlled Trial Presenter: Dr. Trevor M. Feinstein, Principal investigator for Dublin-3 study, Piedmont Cancer Institute, Atlanta, GA, USAPresentation Time: Monday, September 9, 2024, at 10:57AM to 11:07AM PDTSession: OA08. The New Generation of Cytotoxics ESMO Congress 2024Poster (1358P): Plinabulin/Docetaxel Versus Docetaxel in Survival Benefits of 2L/3L EGFR Wild-Type NSCLC after Platinum Regimens (DUBLIN-3): a Randomized Phase 3 Trial Presenter: Dr. Trevor M. FeinsteinPresentation Time: Saturday, September 14, 2024, at 9AM to 6:30PM CESTLocation: Hall 3, Av. Joan Carles I, 64 08908 L’hospitalet de Llobregat Barcelona, Spain Session: NSCLC, metastatic Poster (1330P): Phase 2 Study of Pembrolizumab (Pemb) plus Plinabulin (Plin) and Docetaxel (Doc) for Patients (pts) with Metastatic NSCLC after Failure on First-line Immune Checkpoint Inhibitor Alone or Combination Therapy: Initial Efficacy and Safety Results on Immune Re-sensitization Presenter: Dr. Yan Xu, Investigator, Peking Union Medical College Hospital, Beijing, ChinaPresentation Time: Saturday, September 14, 2024, at 9AM to 6:30PM CESTLocation: Hall 3, Av. Joan Carles I, 64 08908 L’hospitalet de Llobregat Barcelona, Spain Session: NSCLC, metastatic About BeyondSpringBeyondSpring is a global clinical-stage biopharmaceutical company focused on developing innovative therapies to improve clinical outcomes for patients with high unmet medical needs. The Company is advancing its first-in-class lead asset, Plinabulin, a potent inducer of dendritic cell maturation, in late-stage clinical development as a direct anti-cancer agent in NSCLC and a variety of cancer indications. BeyondSpring’s pipeline also includes three preclinical immuno-oncology assets. Additionally, BeyondSpring is an equity owner of SEED Therapeutics, Inc which is a pioneer in Target Protein Degradation technology and its application in innovative drug development. Learn more by visiting https://beyondspringpharma.com. About Dublin-3 StudyDublin-3 NSCLC was a global Phase 3 randomized, controlled clinical trial comparing the combination of Plinabulin and docetaxel to an active control arm of docetaxel alone (1:1 randomization) in second- and third-line NSCLC patients who had failed platinum doublet therapies, and who were Epidermal Growth Factor Receptor (EGFR) wild-type. Docetaxel was given on Day 1 in both arms at 75 mg/m2 in each 21-day cycle. Plinabulin was given on Day 1, one hour after docetaxel, and on Day 8, both at 30 mg/m2 in each cycle. The primary endpoint for the study was overall survival, and secondary endpoints were Progression Free Survival (PFS), Overall Response Rate (ORR), Duration of Response (DoR), Grade 4 neutropenia and Quality of Life. About 303 StudyStudy 303 is an open-label, single-arm Phase 2 Study of Plinabulin plus docetaxel and pembrolizumab for previously treated patients with metastatic NSCLC and progressive disease after anti-PD-(L)1 inhibitor alone or in combination with platinum-doublet chemotherapy. This study evaluates the efficacy and safety of this triple combination and is being conducted at Peking Union Medical College Hospital, Beijing, China with Dr. Mengzhao Wang, Chief of the Department of Respiratory and Critical Care Medicine, as the principal investigator and with Merck. Patients enrolled are receiving the following interventional treatments. The primary endpoint is investigator-based ORR (RECIST 1.1). The secondary endpoints include PFS, OS, DoR, and safety. The study intends to enroll 47 patients with a formal interim analysis of 19 patients enrolled. The regimen includes Pembrolizumab 200 mg IV every 3 weeks (Q3W) on Day 1, Docetaxel 75 mg/m2 IV Q3W on Day 1 and Plinabulin 30mg/m2 IV Q3W on Day 1 in a 21-day cycle. The study is funded by Merck’s Investigator Studies Program with provision of study drug and financial support. Investor Contact:IR@beyondspringpharma.com Media Contact:PR@beyondspringpharma.com

Phase 3Phase 2Clinical ResultImmunotherapy

100 Deals associated with Plinabulin

External Link

KEGG	Wiki	ATC	Drug Bank
D09655	Plinabulin	-	DB05992

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Neutropenia	Preclinical	CN	Pharmaceutics International, Inc.	17 Aug 2021
Neutropenia	Preclinical	CN	BeyondSpring Pharmaceuticals, Inc.	17 Aug 2021
Neutropenia	Preclinical	CN	Dalian Wanchun Biotechnology Co. Ltd.Startup	17 Aug 2021
Advanced Lung Non-Small Cell Carcinoma	Preclinical	CN	BeyondSpring Pharmaceuticals, Inc.	01 Dec 2015
Advanced Lung Non-Small Cell Carcinoma	Preclinical	US	BeyondSpring Pharmaceuticals, Inc.	01 Dec 2015
Advanced Lung Non-Small Cell Carcinoma	Preclinical	AU	BeyondSpring Pharmaceuticals, Inc.	01 Dec 2015
Non-Small Cell Lung Cancer	Preclinical	AU	Dalian Wanchun Biotechnology Co., Ltd.	30 Nov 2015
Non-Small Cell Lung Cancer	Preclinical	US	Pharmaceutics International, Inc.	30 Nov 2015
Non-Small Cell Lung Cancer	Preclinical	US	Dalian Wanchun Biotechnology Co., Ltd.	30 Nov 2015
Non-Small Cell Lung Cancer	Preclinical	AU	Pharmaceutics International, Inc.	30 Nov 2015

Clinical Result

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05599789 (ESMO2024) Manual	Phase 2	metastatic non-small cell lung cancer Second line	19	Pembrolizumab+plinabulin+docetaxel	(tyhzyovzon) = xqhyunosef qtpjfwxnzz (mgbqdayigc ) View more	Positive	14 Sep 2024
NCT02504489 (DUBLIN-3, ESMO2024) Manual	Phase 3	Non-Small Cell Lung Cancer Second line \| Third line EGFR wild-type	559	Plinabulin+Docetaxel	(gyhnyozkdf) = loatmwmorf dlnqnwwebe (mpqyfkjuic ) View more	Positive	14 Sep 2024
				Placebo+Docetaxel	(gyhnyozkdf) = utrywqhnvg dlnqnwwebe (mpqyfkjuic ) View more
NCT03102606 (PROTECTIVE-1 \| Study 105 \| BPI-2358-105, CTgov)	Phase 3	Chemotherapy-Induced Febrile Neutropenia \| Solid tumor	105	D5W Placebo (Docetaxel (75 mg/m2) + Pegfilgrastim (6 mg) + Placebo Matching Plinabulin)	smhkhhfldm(stsrlehhqa) = qbujveuxrb ixjqyiaurq (jxdhwemjri, koatbmsjai - kcyssngaqf) View more	-	29 Aug 2024
				Saline Placebo+Plinabulin (Docetaxel (75 mg/m2) + Plinabulin (40 mg) + Placebo Matching Pegfilgrastim)	smhkhhfldm(stsrlehhqa) = ibxsxdzknq ixjqyiaurq (jxdhwemjri, mhpibjyxpr - epnjkvfjdj) View more
NCT04345900 (CTgov)	Phase 2	Chemotherapy-Induced Febrile Neutropenia \| Solid tumor	55	Pegfilgrastim+Docetaxel (Arm 1)	eqpsadkkww(tsmlcttpsl) = gtzpklbdci qfaficydgu (cbthtjeufj, xqxglvxihl - ryeirwfuxp) View more	-	16 May 2024
				Plinabulin+Docetaxel (Arm 2)	eqpsadkkww(tsmlcttpsl) = oqxdxmecdv qfaficydgu (cbthtjeufj, rlvltkszgt - fdmrxzgwvz) View more
EHA2024	Not Applicable	-	-	Plinabulin	ylxbrdjvrn(jftnvloppy) = aenkcgyjph vxkypahfwm (dqewcokyqv )	Positive	14 May 2024
				Selumetinib	ylxbrdjvrn(jftnvloppy) = dbfkcbqhzm vxkypahfwm (dqewcokyqv )
IMS2023	Not Applicable	Multiple Myeloma	15	Plinabulin + pegfilgrastim	xdczbiuiov(pulhxhaekz) = rqccqslptr jqxwxjkecu (vujmbbvyke ) View more	-	26 Sep 2023
NCT02504489 (ASCO2023) Manual	Phase 2/3	Non-Small Cell Lung Cancer	-	Plinabulin+Docetaxel	(unyhjbdpdm) = With Plin, AE frequency of diarrhea was slightly higher (5.2% vs 1%; 1 Gr4 case with Plin), but was manageable, and so was hypertension (11.2% vs 1.7%; all Gr3 cases) vs Plac. Hypertension occurred around the time of infusion and was short-lasting (~2-4 hours) and typically self-limiting. Plin had less AEs of neutropenia (16.4% vs 50.3%) and leukopenia (15.5% vs 38.5%) vs Plac. othopvxvan (cgxryatqmu )	Positive	31 May 2023
				Placebo+Docetaxel
NCT03102606 (PROTECTIVE-1, ESMO_ASIA2022)	Phase 2/3	Non-Small Cell Lung Cancer	30	Plinabulin	xlzpyrmbym(uznuzbtkbz) = nvfiwlhpuz atweylehil (xhccrjhkai )	Positive	03 Dec 2022
NCT03294577 (PROTECTIVE-2, Corporate Publications) Manual	Phase 3	Neutropenia	115	Pegfilgrastim+Plinabulin	(idgwxwhccp) = lsjfzxaegu oiuupcuguv (ksxgvqngiu )	Positive	21 Oct 2022
				Pegfilgrastim	(idgwxwhccp) = mxkvyahrzw oiuupcuguv (ksxgvqngiu )
NCT03102606 \| NCT03294577 (PROTECTIVE-2, ESMO2022) Manual	Phase 2/3	Uterine Cervical Dysplasia	496	Plinabulin 20 mg/m2 / 40 mg	duwtzqarie(ahyhuyxsis) = epkkghtwuo eqduxeyhse (druiloxvpr ) View more	Positive	10 Sep 2022
				Docetaxel 75 mg/m2 or Doxorubicin 50 mg/m2	duwtzqarie(ahyhuyxsis) = cdgkmebpfn eqduxeyhse (druiloxvpr ) View more

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