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BeyondSpring Presents Updated Efficacy Results From a Phase 2 IIT Study of Triple IO Combo of Pembrolizumab Plus Plinabulin/Docetaxel in Metastatic NSCLC After Progressing on Prior Immune Checkpoint Inhibitors at the 39th SITC Annual Meeting

BeyondSpring Presents Updated Efficacy Results From a Phase 2 IIT Study of Triple IO Combo of Pembrolizumab Plus Plinabulin/Docetaxel in Metastatic NSCLC After Progressing on Prior Immune Checkpoint Inhibitors at the 39th SITC Annual Meeting

萬春醫藥在第39屆海豐國際年會上發佈了來自於一項II期研究的最新療效結果,研究關於轉移性非小細胞肺癌在之前免疫檢查點抑制劑治療失效後接受Pembrolizumab加Plinabulin/Docetaxel三聯療法。
GlobeNewswire ·  11/11 21:00

In 30 metastatic NSCLC patients who progressed on PD-1/PD-L1 inhibitors, the triple IO combo regimen at median follow-up time of 11.5 months achieved a DCR of 89.3% and Median PFS of 8.6 months

在30名PD-1/PD-L1抑制劑進展的轉移性非小細胞肺癌患者中,三聯免疫治療方案在中位隨訪時間爲11.5個月時,實現了89.3%的疾病控制率(DCR)和8.6個月的中位無進展生存期(PFS)

FLORHAM PARK, N.J., Nov. 11, 2024 (GLOBE NEWSWIRE) -- BeyondSpring Inc. (NASDAQ: BYSI) ("BeyondSpring" or the "Company"), a clinical-stage global biopharmaceutical company developing innovative cancer therapies, today announced that phase 2 IIT (Investigator-initiated) data on the first 30 patients dosed with plinabulin in the 303 Study of patients with non-small cell lung cancer (NSCLC) after disease progression on PD-1/PD-L1 inhibitors with and without chemotherapy were presented at the 39th Society for Immunotherapy of Cancer's (SITC) Annual Meeting on November 8th, 2024 in Houston, Texas.

新澤西州FLORHAM PARK,2024年11月11日(全球新聞社)—BeyondSpring Inc.(納斯達克股票代碼:BYSI)(「BeyondSpring」或「公司」),一家開發創新癌症療法的臨床階段全球生物製藥公司,今天宣佈,研發了癌症創新療法的臨床階段全球生物製藥公司的第2階段IIt(由調查員發起)數據,在納斯達克股票代碼爲BYSI的303研究中向30名接受小基站-5gPD-1/PD-L1抑制劑並伴有或不伴有化療的NSCLC患者首次使用鉑金達安全治療的情況在2024年11月8日於德克薩斯州休斯頓舉行的第39屆免疫治療學會(SITC)年會上宣佈。

Docetaxel remains the standard of care for patients with 2L/3L NSCLC without targetable alterations who progress on immune checkpoint inhibitors (ICI) with and without standard chemotherapy. In the recent TROPION Lung-01 phase 3 studies, a similar patient population had an overall response rate (ORR) of 12.8% and median PFS (mPFS) of 3.7 months. 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.

多西紫杉醇仍然是對於PD-1/L1抑制劑後疾病進展的無法靶向改變的2L/3L NSCLC患者的標準治療。在最近的TROPION Lung-01第3期研究中,類似的患者群體的總體有效率(ORR)爲12.8%,中位無進展生存期(mPFS)爲3.7個月。對於先前對PD-1/L1治療產生抗藥性的轉移性NSCLC患者,PD-L1和CTLA-4抑制療法單獨或與低劑量分次放療結合對患者產生了約11.5%的總體有效率。

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 updated results from 30 patients.

這項由調查員發起的單臂、開放標籤、第2階段研究(KeyPelms-004或303研究)評估了pembrolizumab加鉑金達/多西紫杉醇(NCT05599789)三聯治療方案的療效和安全性。該研究旨在招募共47名患者,並正在北京大學醫學院附屬醫院進行,主要研究員是呼吸與危重病醫學科主任王夢昭博士。在這裏,我們報道了30名患者的更新結果。

At the database lock on 29 August 2024, 36 patients were enrolled, 30 exposed to the plinabulin regimen. Prior to entry, all patients had experienced disease progression after initial clinical benefit with ICI. Of the 30 treated patients (median age at 68.0 years; ranged 50-77 years), 73.3% were male and 26.7% were female; 60% were current or former smokers. Histology included 57% patients (n=17) with non-squamous cell carcinoma and 43% (n=13) with squamous cell carcinoma. The median follow-up was 11.5 months. Below is an efficacy summary table:

在2024年8月29日的數據庫鎖定時,共有36名患者入組,其中30名接受了鉑金達方案。在入組前,所有患者在接受免疫檢查點抑制劑後均經歷了疾病進展。在30名接受治療的患者中(中位年齡爲68.0歲;範圍爲50-77歲),73.3%爲男性,26.7%爲女性;60%爲吸菸者或曾吸菸者。組織學包括57%的非鱗狀細胞癌患者(n=17)和43%的鱗狀細胞癌患者(n=13)。中位隨訪時間爲11.5個月。下表爲療效摘要:

Primary Endpoint Plinabulin + Pembrolizumab + Docetaxel (n=30)
Confirmed ORR (RECIST 1.1) 21.1%
Secondary Endpoints
Median PFS (RECIST 1.1) 8.6 M
Median OS
(Overall Survival)
Not reached
Median DoR
(Duration of Response)
11.4 M
Disease Control Rate
(PR + SD > 4 months)
89.3%
(25/28 – 2 patients withdrew after first dose)
一級終點 Plinabulin + 無礙 + 多西立醇(n=30)
經核實的總體有效率 (RECISt 1.1) 21.1%
二級終點
中位無進展生存期 (RECISt 1.1) 8.6百萬
中位總生存期
(總體生存期)
未達到
中位持續反應時間
(回應持續時間)
11.4百萬
疾病控制率
(PR + SD > 4個月)
89.3%
(25/28 - 2名患者在第一劑後退出)
  • The combination was generally well tolerated. 46.7% of patients experienced grade 3 or higher treatment-related adverse effects. Most common AE is myelosuppression (13.3%), GI side effect (13.3%), and transient hypertension (6.7%). There were no treatment-related deaths.
  • Results are consistent with the data reported on the first 19 patients in Study 303 at ESMO in September.
  • 這種組合通常耐受良好。46.7%的患者出現了3級或更高級別的與治療相關的不良反應。最常見的不良事件是骨髓抑制(13.3%),胃腸道副作用(13.3%),以及暫時性高血壓(6.7%)。沒有與治療相關的死亡。
  • 結果與在九月的ESMO 303研究中對頭19名患者報告的數據一致。

"Plinabulin is a potent inducer of dendritic cell or DC maturation that leads to T cell activation. DCs are 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 alteration or T cell exhaustion. Compared to historical controls of 3-4 months of median PFS2, the efficacy data with 30 patients maintained a doubled median PFS at 8.6 months, coupled with an impressive disease control rate of almost 90%, which continues to be encouraging and clinically meaningful for this severe unmet need," said Dr. Mengzhao Wang, principal investigator at Peking Union Medical College Hospital.

「Plinabulin是一種強效的樹突狀細胞或DC成熟的誘導劑,導致t細胞激活。DCs是最強效的抗原提呈細胞(APC)。這種獨特的作用機制強化了抗腫瘤免疫應答,有潛力克服由於APC通路改變或t細胞耗竭而產生的獲得性ICI抵抗。與歷史對照組的3-4個月的中位PFS2相比,30名患者的有效數據保持在8.6個月的中位PFS,伴隨着將近90%的令人印象深刻的疾病控制率,繼續對這種嚴重未滿足需求的鼓舞和臨床意義。」北京協和醫院的王夢照博士說,王博士是主要研究員。

SITC 2024 Abstract Title: Phase 2 Study of Pembrolizumab (pemb) plus Plinabulin (plin) and Docetaxel (doc) for Metastatic NSCLC after Failure on First-line Immune Checkpoint Inhibitor Alone or Combination Therapy: Updated Efficacy and Safety Results on Immune Re-sensitization

海豐國際2024年摘要標題:Pembrolizumab(pemb)聯合Plinabulin(plin)和Docetaxel(doc)用於一線免疫檢查點抑制劑或聯合療法失敗後轉移性非小細胞肺癌的2期研究:免疫再敏感性更新的療效和安全性結果

  • Presenting Author: Dr. Yan Xu, Peking Union Medical College Hospital
  • Abstract Number: 1491
  • 報告作者:北京協和醫院徐巖博士
  • 摘要編號:1491

References:

參考文獻:

  1. Schoenfeld et al. 2022, Lancet Oncology 23:279-291
  2. Ahn et al. 2024, TROPION Lung-01 Study, Journal of Clinical Oncology,
  1. Schoenfeld等人,2022年,全球性醫學期刊《腫瘤學報》,23:279-291
  2. Ahn等人2024年,《臨床腫瘤學雜誌》,TROPION Lung-01研究

About Plinabulin
Plinabulin 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. Around 800 patients have been treated with plinabulin with good tolerability.

關於Plinabulin
Plinabulin是一種新型的首創性樹突狀細胞成熟療法,經多項臨床研究觀察到持久的抗癌效益。作爲一種可逆結合在不同微管口袋上的結合劑,Plinabulin不改變微管動力學,也不對抗微管穩定劑,比如紫杉醇,這有助於與其他微管結合劑相比具有不同的活性和耐受性。此外,Plinabulin可以顯著減少化療引起的中性粒細胞減少,並可能增加對紫杉醇的耐受性。約有800名患者接受了Plinabulin治療,耐受性良好。

About 303 Study
303 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. The study is funded by Merck's Investigator Studies Program with provision of study drug and financial support.

關於303研究
303研究是一項開放標籤的、單臂的第2期研究,評估了Plinabulin聯合紫杉醇和帕博利珠單抗治療之前接受過PD-(L)1抑制劑單獨或聯合白金雙藥化療的轉移性NSCLC患者,並在抗PD-(L)1單藥或組合治療後出現疾病進展。該研究評估了這種三聯療法的療效和安全性,並在中國北京的北京協和醫院進行。療程包括帕博利珠單抗每3周靜脈注射200毫克(Q3W)第1天,紫杉醇每3周IV 75毫克/m2第1天和Plinabulin每3周IV 30毫克/m2第1天,每21天爲一個週期。主要終點是調查者評估的ORR(RECISt 1.1)。次要終點包括PFS、OS、DoR和安全性。該研究計劃招募47名患者。該研究由默沙東的調查員研究計劃資助,提供研究藥物和財務支持。

About BeyondSpring
BeyondSpring 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 .

關於萬春醫藥
萬春醫藥是一家全球臨床階段的生物製藥公司,致力於開發創新療法,改善對臨床需求高但尚未滿足的患者的臨床結果。該公司正在推進其首個一類新藥鉑林,作爲一種直接的抗癌劑,在非小細胞肺癌和多種癌症適應症中作爲強效的樹突狀細胞成熟誘導劑的後期臨床開發。萬春醫藥的創新藥物管線還包括三個臨床前的免疫腫瘤學資產。此外,萬春醫藥是SEED Therapeutics, Inc 的股權擁有者, SEED Therapeutics是目標蛋白降解技術和其在創新藥物開發中的應用方面的先驅者。了解更多信息,請訪問。

Investor Contact:
IR@beyondspringpharma.com

投資者聯繫人:
IR@beyondspringpharma.com

Media Contact:
PR@beyondspringpharma.com

媒體聯繫:
PR@beyondspringpharma.com


譯文內容由第三人軟體翻譯。


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