54% complete response (CR) rate at 24-month landmark and meets primary endpoint of the phase 2 study
IRVINE, Calif., May 24, 2024 (GLOBE NEWSWIRE) -- CG Oncology, Inc. (NASDAQ: CGON), a late-stage clinical biopharmaceutical company focused on developing and commercializing a potential backbone bladder-sparing therapeutic for patients with bladder cancer, today announced final results from the Phase 2 CORE-001 clinical trial of its oncolytic immunotherapy candidate, cretostimogene, in combination with pembrolizumab for the treatment of BCG-Unresponsive, High-Risk Non-Muscle Invasive Bladder Cancer (HR-NMIBC) with Carcinoma in Situ (CIS). The data will be presented at the American Society of Clinical Oncology (ASCO) 2024 Annual Meeting from May 31-June 4, in Chicago, IL.
"There is a significant unmet need for new and innovative treatments for patients suffering with bladder cancer. We are encouraged by the final safety and efficacy data from our CORE-001 Phase 2 trial which showed a class-leading complete response (CR) and duration of response (DoR) compared to existing FDA-approved therapies and other investigational candidates," said Vijay Kasturi, MD, Chief Medical Officer, CG Oncology. "We look forward to sharing these data at ASCO, as they reinforce the potential use of cretostimogene as a bladder-sparing backbone therapy for NMIBC, which is generally well tolerated by patients, either as monotherapy or in combination. Additionally, we believe these results support further investigation of cretostimogene in combination with checkpoint inhibitors and we plan to incorporate these findings into our planned CORE-008 trial in high-risk NMIBC."
CORE-001 Final Results:
As of the data cutoff on February 5, 2024, the CR rate in the intention-to-treat (ITT) population at 12-months and any time, was 57% (20/35) [95% confidence interval (CI), 40-73%] and 83% (29/35) (95% CI, 70-95%), respectively. As of May 17, 2024, the CR rate in the ITT population at 24 months was 54% (19/35) (95% CI, 37-71%).
Of the patients in a CR at 12 months, 95% of patients (19/20) maintained a CR for another 12 months.
Median DoR has not been reached but exceeds 21 months.
Additionally, the Kaplan-Meier estimates for CR rate at 12 and 24 months were 77.3% (95% CI, 58.1-88.5%) and 69.6% (95% CI, 49.4-83.0%), respectively.
Progression-free survival (PFS) at 24 months is 100% with no patients progressing to muscle invasive cancer or metastatic disease; Cystectomy-free survival (CFS) at 24 months was 80%; for patients in CR, CFS at 24 months was 100%.
Treatment-related adverse events (TRAEs) were consistent with the individual agents and demonstrate no synergistic toxicity. Results to be presented are an update from previously reported data in the abstract.
Details of the ASCO poster are as follows:
Title: Final results of CORE-001 trial of Cretostimogene Grenadenorepvec in Combination with Pembrolizumab in Patients with BCG-Unresponsive, High-Risk, Non-Muscle Invasive Bladder Cancer with Carcinoma in Situ
Abstract Number: 4601
Session & Primary Track: Poster Session, Genitourinary Cancer - Kidney and Bladder
Presenter: Roger Li, M.D., lead study investigator and Urologic Oncologist at Moffitt Cancer Center
Presentation Date & Time: June 2, 2024, 9:00-10:00am Central Daylight Time
Location: McCormick Place Convention Center, Hall A
The Phase 2 CORE-001 trial was conducted in collaboration with Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA. The combination of cretostimogene and pembrolizumab received FDA Breakthrough Therapy Designation in May 2023.
Cretostimogene monotherapy received FDA Fast Track and Breakthrough Therapy Designations in BCG-Unresponsive, HR-NMIBC with CIS in December 2023. CG Oncology recently presented data from the Phase 3 BOND-003 trial at the 2024 American Urological Association Annual Meeting which showed sustained durable responses over 12 months and a 75.2% complete response rate. Topline data from BOND-003 is expected by the end of 2024, and the Company is on track for a regulatory approval submission. To learn more about the results from BOND-003 you may read the Company's press release issued on May 3, 2024.
About Cretostimogene Grenadenorepvec
Cretostimogene is an investigational, intravesically delivered oncolytic immunotherapy being evaluated in BOND-003, a Phase 3 clinical trial for the treatment of patients with high-risk Non-Muscle Invasive Bladder Cancer (NMIBC) who are unresponsive to Bacillus Calmette Guerin (BCG) therapy. Cretostimogene is also being evaluated in a Phase 3 monotherapy clinical trial (PIVOT-006) in intermediate-risk NMIBC patients. In addition, cretostimogene is being evaluated in an investigator-sponsored clinical trial in combination with nivolumab for the treatment of muscle invasive bladder cancer.
Cretostimogene is an investigational, intravesically delivered oncolytic immunotherapy candidate, and its safety and efficacy have not been established by the FDA or any other health authority.
About the CORE-001 Study
CORE-001 was a Phase 2 single-arm, open-label clinical trial of cretostimogene administered in 35 patients with high-risk, BCG-Unresponsive NMIBC that have carcinoma in situ-containing tumors, in combination with pembrolizumab, following disease resection. CORE-001 was conducted pursuant to a clinical collaboration and supply agreement with Merck (known as MSD outside the United States and Canada). More information about the study, CORE-001 (NCT04387461), along with other studies sponsored by CG Oncology.
在24個月的里程碑時完全緩解（CR）率爲54％，符合2期研究的主要終點
加利福尼亞州爾灣，2024年5月24日（GLOBE NEWSWIRE）——專注於爲膀胱癌患者開發和商業化一種潛在的骨幹膀膀胱保護療法的後期臨床生物製藥公司CG Oncologene公司（納斯達克股票代碼：CGON）今天公佈了其溶瘤免疫療法候選藥物cretostimogene與pembrozugene聯合進行的二期 CORE-001 臨床試驗的最終結果 mab 用於治療 BCG 無反應、高風險的非肌肉浸潤性膀胱癌 (HR-NMIBC) 伴原位癌 (CIS)。這些數據將在5月31日至6月4日在伊利諾伊州芝加哥舉行的美國臨床腫瘤學會（ASCO）2024年年會上公佈。
“膀胱癌患者對新的創新療法的需求仍有大量未得到滿足。CG Oncology首席醫學官Vijay Kasturi醫學博士說，我們的 CORE-001 2期試驗的最終安全性和有效性數據令我們感到鼓舞，該試驗顯示出與美國食品藥品管理局批准的現有療法和其他候選藥物相比，完全反應（CR）和緩解持續時間（DoR）處於同類領先地位。“我們期待在ASCO分享這些數據，因爲它們強化了cretostimogene作爲NMIBC的膀胱保護主幹療法的潛在用途，無論是單一療法還是聯合療法，患者對NMIBC的耐受性通常都很好。此外，我們認爲這些結果支持對cretostimogene聯合檢查點抑制劑的進一步研究，我們計劃將這些發現納入我們計劃在高風險NMIBC中進行的 CORE-008 試驗中。”
CORE-001 最終成績：
截至2024年2月5日的數據截止日期，12個月及任何時候的意向治療（ITT）人群的CR率分別爲57％（20/35）[95％置信區間（CI），40-73％] 和83％（29/35）（95％置信區間，70-95％）。截至2024年5月17日，24個月時ITT人群的CR率爲54％（19/35）（95％置信區間，37-71％）。
在12個月時接受CR的患者中，95％的患者（19/20）將CR再維持12個月。
尚未達到 DoR 中位數，但已超過 21 個月。
此外，卡普蘭-邁爾對12個月和24個月時CR率的估計分別爲77.3％（95％置信區間，58.1-88.5％）和69.6％（95％置信區間，49.4-83.0％）。
24個月的無進展存活率（PFS）爲100％，沒有患者進展爲肌肉浸潤性癌症或轉移性疾病；24個月時的無囊腫切除術存活率（CFS）爲80％；對於CR患者，24個月的CFS爲100％。
與治療相關的不良事件（TRAE）與個別藥物一致，沒有顯示出協同毒性。將提供的結果是對先前摘要中報告的數據的更新。
ASCO 海報的詳細信息如下：
標題：Cretostimogene Grenadenorepvec 與 Pembrolizumab 聯合用於 BCG 無反應、高風險、非肌肉浸潤性膀胱癌原位癌患者的 CORE-001 試驗的最終結果
摘要編號：4601
會議和主要專題：海報會議，泌尿生殖系統癌——腎臟和膀胱
主持人：羅傑·李，醫學博士，莫菲特癌症中心首席研究員兼泌尿外科腫瘤學家
演講日期和時間：2024 年 6 月 2 日中部夏令時間上午 9:00-10:00
地點：味好美廣場會議中心，A廳
CORE-001 第二階段試驗是與位於美國新澤西州拉威的默沙東公司的子公司默沙東夏普和多姆有限責任公司合作進行的。cretostimogene 和 pembrolizumab 的組合於 2023 年 5 月獲得 FDA 突破性療法稱號。
Cretostimogene單一療法於2023年12月在BCG無反應、HR-NMIBC和CIS中獲得美國食品藥品管理局的快速通道和突破性療法認定。CG Oncology 最近在 2024 年美國泌尿外科學會年會上公佈了 3 期 BOND-003 試驗的數據，該數據顯示在 12 個月內持續出現持續的持續反應，完全緩解率爲 75.2%。BOND-003 的頭條數據預計將於 2024 年底公佈，該公司有望提交監管部門的批准。要了解有關 BOND-003 結果的更多信息，您可以閱讀該公司於 2024 年 5 月 3 日發佈的新聞稿。
關於 Cretostimogene Grenadenorepvec
Cretostimogene是一項正在研究的、經靜脈注射的溶瘤免疫療法，正在 BOND-003 中進行評估。是一項三期臨床試驗，旨在治療對卡氏桿菌（BCG）療法無反應的高危非肌肉浸潤性膀胱癌（NMIBC）患者。一項針對中等風險NMIBC患者的3期單一療法臨床試驗（PIVOT-006）也在對Cretostimogene進行評估。此外，一項由研究人員贊助的與nivolumab聯合治療肌肉浸潤性膀胱癌的臨床試驗正在對cretostimogene進行評估。
Cretostimogene是一種正在研究的、經靜脈注射的溶瘤免疫療法候選藥物，其安全性和有效性尚未由美國食品藥品管理局或任何其他衛生機構確定。
關於 CORE-001 研究
CORE-001 是一項 cretostimogene 的 2 期單臂、開放標籤臨床試驗，用於 35 名患有原位腫瘤的高風險、BCG 無反應的 NMIBC 患者，在疾病切除後與派姆羅利珠單抗聯合使用。CORE-001 是根據與默沙東（在美國和加拿大以外稱爲默沙東）的臨床合作和供應協議進行的。有關這項研究 CORE-001（NCT04387461）以及由CG Oncology贊助的其他研究的更多信息。
