Immunocore Presents KIMMTRAK Clinical Data Demonstrating That Patients With Stable Disease and Confirmed Tumor Reduction Have Similar Clinical Outcomes to Patients With Partial Response
Immunocore Presents KIMMTRAK Clinical Data Demonstrating That Patients With Stable Disease and Confirmed Tumor Reduction Have Similar Clinical Outcomes to Patients With Partial Response
Immunocore presents KIMMTRAK clinical data demonstrating that patients with stable disease and confirmed tumor reduction have similar clinical outcomes to patients with partial response
Immunocore提供的KIMMTRAK臨床數據表明,病情穩定且經證實腫瘤減少的患者與部分緩解患者的臨床結果相似
Data were presented at ASCO 2024, where Immunocore also presented Phase 1 data from its PRAME trial with brenetafusp (IMC-F106C) in advanced cutaneous melanoma
數據已在 ASCO 2024 上公佈,Immunocore 還展示了其在晚期皮膚黑色素瘤中使用 brenetafusp (IMC-F106C) 進行的 PRAME 試驗的 1 期數據
(OXFORDSHIRE, England & CONSHOHOCKEN, PA & ROCKVILLE, MD, US, June 1, 2024) Immunocore Holdings plc (Nasdaq: IMCR) ("Immunocore" or the "Company"), a commercial-stage biotechnology company pioneering and delivering transformative immunomodulating medicines to radically improve outcomes for patients with cancer, infectious diseases and autoimmune diseases, today presented three posters about KIMMTRAK (tebentafusp-tebn) for the treatment of patients with unresectable or metastatic uveal melanoma (mUM) at the 2024 ASCO (American Society for Clinical Oncology) Annual Meeting. These data showed that treatment benefit for patients with stable disease and any confirmed tumor reduction was similar to patients with partial response.
(英格蘭牛津郡、賓夕法尼亞州康舍霍肯和美國馬里蘭州羅克維爾,2024年6月1日)Immunocore Holdings plc(納斯達克股票代碼:IMCR)(“Immunocore” 或 “公司”)是一家處於商業階段的生物技術公司,開創並提供變革性免疫調節藥物,以從根本上改善癌症、傳染病和自身免疫性疾病患者的預後,今天展示了三張關於KIMMTRAK的海報(tebentafusp-tebn) 用於在 2024 年 ASCO(美國臨床腫瘤學會)年會上治療不可切除或轉移性葡萄膜黑色素瘤(MuM)患者會議。這些數據表明,病情穩定且任何已證實腫瘤減少的患者的治療益處與部分緩解患者的治療益處相似。
"In both Phase 2 and Phase 3 KIMMTRAK trials, patients with stable disease and durable tumor reduction, regardless of depth, had similar benefit as patients with RECIST partial response," said Mohammed Dar, Senior Vice President, Clinical Development, and Chief Medical Officer, Immunocore. "The data presented at ASCO builds upon the mounting evidence confirming that disease control is the best early radiographic measure of clinical benefit across our ImmTAC platform."
Immunocore臨床開發高級副總裁兼首席醫學官穆罕默德·達爾表示:“在KIMMTRAK的2期和3期試驗中,無論深度如何,病情穩定且腫瘤持續減少的患者都與RECIST部分反應的患者具有相似的益處。”“ASCO提供的數據建立在越來越多的證據基礎上,這些證據證實疾病控制是我們ImmTac平台上衡量臨床益處的最佳早期放射照相測量方法。”
"KIMMTRAK is now the standard of care, in launched countries, for HLA-A*02:01-positive patients with metastatic or unresectable uveal melanoma," said Ralph Torbay, Immunocore's Chief Commercial Officer. "Physicians can now leverage these data, presented at ASCO today, to positively inform their conversations with patients who have stable disease and minor reductions in tumor size."
Immunocore首席商務官拉爾夫·託貝表示:“在啓動的國家,KIMMTRAK現在是HLA-A* 02:01 陽性轉移性或不可切除葡萄膜黑色素瘤患者的護理標準。”“醫生現在可以利用今天在ASCO上提供的這些數據,爲他們與病情穩定且腫瘤大小略減小的患者的對話提供積極信息。”
Of the 127 patients treated with KIMMTRAK in the Phase 2 trial (IMCgp100-102), 25% (32/127) had any tumor reduction that was confirmed in at least one subsequent scan, including 6 partial responses (PR), an overall response rate of 5%, and 20% (26/127) stable disease (SD). The clinical outcomes in the 26 patients with SD were similar to the 6 PR patients, including durable duration of tumor reduction or response, ctDNA molecular response, and overall survival. In the Phase 3 trial (IMCgp100-202), KIMMTRAK-treated patients with SD who had any confirmed tumor reduction had durability of tumor reduction of 11 months, which was the same as the durability of response for patients with RECIST PR or CR.
在2期試驗(imcGP100-102)中接受KIMMTRAK治療的127名患者中,有25%(32/127)的腫瘤減少在隨後的至少一次掃描中得到證實,包括6種部分反應(PR),總緩解率爲5%,以及20%(26/127)的穩定疾病(SD)。26名SD患者的臨床結果與6名PR患者相似,包括腫瘤減少或反應的持續時間、ctDNA分子反應和總存活率。在3期試驗(imcGP100-202)中,接受KimmTrak治療的SD患者如果已確認腫瘤減退,其腫瘤減少的持續時間爲11個月,這與RECIST PR或CR患者的反應持續時間相同。
Full poster details:
完整海報詳情:
Stable disease with confirmed tumor reduction has a similar clinical outcome as RECIST partial response for tebentafusp in metastatic uveal melanoma
Presenting author: Alexandra Ikeguchi
經證實腫瘤減少的穩定疾病的臨床結果與轉移性葡萄膜黑色素瘤中tebentafusp的RECIST部分反應相似
主講作者:亞歷山德拉·池口
Association between clinical and disease characteristics and detectable or undetectable baseline ctDNA in patients with metastatic uveal melanoma
Presenting author: Paul Nathan
轉移性葡萄膜黑色素瘤患者的臨床和疾病特徵以及可檢測到或無法檢測到的基線 ctDNA 之間的關係
主講作者:保羅·內森
Baseline and serial ctDNA dynamics predicts outcomes in patients treated with first-line tebentafusp including those who were and were not treated beyond progression
Presenting author: Ryan Sullivan
基線和序列ctDNA動態預測接受一線tebentafusp治療的患者的預後,包括那些在進展之後接受過和未接受過治療的患者
主講作者:瑞安·沙利文
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About Immunocore
關於 Immunocore
Immunocore is a commercial-stage biotechnology company pioneering the development of a novel class of TCR bispecific immunotherapies called ImmTAX – Immune mobilizing monoclonal TCRs Against X disease – designed to treat a broad range of diseases, including cancer, autoimmune, and infectious disease. Leveraging its proprietary, flexible, off-the-shelf ImmTAX platform, Immunocore is developing a deep pipeline in multiple therapeutic areas, including nine active clinical and pre-clinical programs in oncology, infectious diseases, and autoimmune diseases. The Company's most advanced oncology TCR therapeutic, KIMMTRAK has been approved for the treatment of HLA-A*02:01-positive adult patients with unresectable or metastatic uveal melanoma in the United States, European Union, Canada, Australia, and the United Kingdom.
Immunocore是一家處於商業階段的生物技術公司,率先開發了一種名爲ImmTax的新型TCR雙特異性免疫療法,即針對X病的免疫調動單克隆TCR,旨在治療各種疾病,包括癌症、自身免疫和傳染病。利用其專有、靈活的現成ImmTax平台,Immunocore正在多個治療領域開發深度產品線,包括腫瘤學、傳染病和自身免疫性疾病方面的九個活躍臨床和臨床前項目。KIMMTRAK是該公司最先進的腫瘤學TCR療法,已獲准在美國、歐盟、加拿大、澳大利亞和英國用於治療HLA-A* 02:01 陽性的不可切除或轉移性葡萄膜黑色素瘤的成年患者。
About KIMMTRAK
關於 KIMMTRAK
KIMMTRAK is a novel bispecific protein comprised of a soluble T cell receptor fused to an anti-CD3 immune-effector function. KIMMTRAK specifically targets gp100, a lineage antigen expressed in melanocytes and melanoma. This is the first molecule developed using Immunocore's ImmTAC technology platform designed to redirect and activate T cells to recognize and kill tumor cells. KIMMTRAK has been approved for the treatment of HLA-A*02:01-positive adult patients with unresectable or metastatic uveal melanoma in the United States, European Union, Canada, Australia, and the United Kingdom.
KIMMTRAK是一種新型雙特異蛋白,由融合了抗CD3免疫效應器功能的可溶性T細胞受體組成。KIMMTRAK專門靶向gp100,這是一種在黑色素細胞和黑色素瘤中表達的譜系抗原。這是第一個使用Immunocore的immTac技術平台開發的分子,該平台旨在重定向和激活T細胞以識別和殺死腫瘤細胞。在美國、歐盟、加拿大、澳大利亞和英國,KIMMTRAK已獲准用於治療HLA-A* 02:01 陽性的不可切除或轉移性葡萄膜黑色素瘤的成年患者。
About Phase 2 IMCgp100-102 Trial
關於第二階段 imcGP100-102 試驗
IMCgp100-102 (NCT02570308) was an open-label, multi-center, single-arm trial of the safety and efficacy of tebentafusp in patients with previously treated mUM. The trial included 127 HLA-A*02:01+ 2L+ mUM patients, treated with tebentafusp at the recommended Phase 2 dose of 68mcg following intra-patient dose escalation of 20 mcg (week 1) and 30 mcg (week 2). The primary endpoint was objective response rate by blinded independent central review, with secondary objectives being overall survival (OS) and safety in 127 patients who had enrolled after progressing on one or more prior therapies.
imcGP100-102(NCT02570308)是一項開放標籤、多中心、單臂試驗,旨在研究tebentafusp對先前接受過治療的mUm患者的安全性和有效性。該試驗包括127名HLA-A* 02:01 + 2L+ mUm患者,在患者內劑量增加20 mcg(第1周)和30 mcg(第2周)之後,使用tebentafusp進行治療,推薦的2期劑量爲68mcg。主要終點是盲目獨立中心審查的客觀緩解率,次要目標是先前一種或多種療法進展後入組的127名患者的總存活率(OS)和安全性。
About Phase 3 IMCgp100-202 Trial
關於第三階段 imcGP100-202 試驗
IMCgp100-202 (NCT03070392) is a randomized pivotal trial that evaluated overall survival (OS) of KIMMTRAK compared to investigator's choice (either pembrolizumab, ipilimumab, or dacarbazine) in HLA-A*02:01-positive adult patients with previously untreated mUM. KIMMTRAK demonstrated an unprecedented OS benefit with a Hazard Ratio (HR) in the intent-to-treat population favoring KIMMTRAK, HR=0.51 (95% CI: 0.37, 0.71); p< 0.0001, over investigator's choice (82% pembrolizumab; 13% ipilimumab; 6% dacarbazine).
imcGP100-202(NCT03070392)是一項隨機關鍵試驗,評估了KIMMTRAK的總存活率(OS)與研究者的選擇(pembrolizumab、ipilimumab或達卡巴嗪)對照HLA-A* 02:01 陽性且以前未接受過治療的成年患者。KIMMTRAK顯示出前所未有的操作系統益處,在意向治療人群中,危害率(HR)偏向KIMMTRAK,HR=0.51(95% 置信區間:0.37,0.71);p
IMPORTANT SAFETY INFORMATION
重要的安全信息
Cytokine Release Syndrome (CRS), which may be serious or life-threatening, occurred in patients receiving KIMMTRAK. Monitor for at least 16 hours following first three infusions and then as clinically indicated. Manifestations of CRS may include fever, hypotension, hypoxia, chills, nausea, vomiting, rash, elevated transaminases, fatigue, and headache. CRS occurred in 89% of patients who received KIMMTRAK with 0.8% being grade 3 or 4. Ensure immediate access to medications and resuscitative equipment to manage CRS. Ensure patients are euvolemic prior to initiating the infusions. Closely monitor patients for signs or symptoms of CRS following infusions of KIMMTRAK. Monitor fluid status, vital signs, and oxygenation level and provide appropriate therapy. Withhold or discontinue KIMMTRAK depending on persistence and severity of CRS.
接受KIMMTRAK治療的患者會出現可能嚴重或危及生命的細胞因子釋放綜合徵(CRS)。在前三次輸液後監測至少 16 小時,然後按照臨床指示進行監測。CRS 的表現可能包括髮燒、低血壓、缺氧、寒戰、噁心、嘔吐、皮疹、轉氨酶升高、疲勞和頭痛。在接受KIMMTRAK治療的患者中,有89%出現CRS,其中0.8%爲3級或4級。確保立即獲得藥物和復甦設備以管理 CRS。在開始輸液之前,確保患者血容量適中。密切監測患者在輸注KIMMTRAK後是否有CRS的體徵或症狀。監測體液狀態、生命體徵和氧合水平,並提供適當的治療。根據CRS的持續性和嚴重程度,暫停或停止KIMMTRAK。
Skin Reactions
皮膚反應
Skin reactions, including rash, pruritus, and cutaneous edema occurred in 91% of patients treated with KIMMTRAK. Monitor patients for skin reactions. If skin reactions occur, treat with antihistamine and topical or systemic steroids based on persistence and severity of symptoms. Withhold or permanently discontinue KIMMTRAK depending on the severity of skin reactions.
在接受KIMMTRAK治療的患者中,有91%出現皮膚反應,包括皮疹、瘙癢和皮膚水腫。監測患者的皮膚反應。如果出現皮膚反應,根據症狀的持續性和嚴重程度使用抗組胺藥和局部或全身性類固醇進行治療。根據皮膚反應的嚴重程度暫停或永久停用 KIMMTRAK。
Elevated Liver Enzymes
肝酶升高
Elevations in liver enzymes occurred in 65% of patients treated with KIMMTRAK. Monitor alanine aminotransferase (ALT), aspartate aminotransferase (AST), and total blood bilirubin prior to the start of and during treatment with KIMMTRAK. Withhold KIMMTRAK according to severity.
在接受KIMMTRAK治療的患者中,有65%的肝酶升高。在開始使用KIMMTRAK治療之前和治療期間,監測丙氨酸氨基轉移酶(ALT)、天冬氨酸氨基轉移酶(AST)和血液總膽紅素。根據嚴重程度扣留 KIMMTRAK。
Embryo-Fetal Toxicity
胚胎-胎兒毒性
KIMMTRAK may cause fetal harm. Advise pregnant patients of potential risk to the fetus and patients of reproductive potential to use effective contraception during treatment with KIMMTRAK and 1 week after the last dose.
KIMMTRAK 可能會對胎兒造成傷害。建議對胎兒有潛在風險的孕婦和具有生殖潛力的患者在使用KIMMTRAK治療期間和最後一次服藥後1周使用有效的避孕措施。
The most common adverse reactions (≥30%) in patients who received KIMMTRAK were cytokine release syndrome, rash, pyrexia, pruritus, fatigue, nausea, chills, abdominal pain, edema, hypotension, dry skin, headache, and vomiting. The most common (≥50%) laboratory abnormalities were decreased lymphocyte count, increased creatinine, increased glucose, increased AST, increased ALT, decreased hemoglobin, and decreased phosphate.
接受KIMMTRAK治療的患者中最常見的不良反應(≥ 30%)是細胞因子釋放綜合徵、皮疹、發熱、瘙癢、疲勞、噁心、寒戰、腹痛、水腫、低血壓、皮膚乾燥、頭痛和嘔吐。最常見(≥ 50%)的實驗室異常是淋巴細胞數量減少、肌酐升高、血糖升高、AST升高、ALT升高、血紅蛋白減少和磷酸鹽減少。