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PO.CT01.02 · 临床试验

Preliminary results from the first-in-human study of MK-2010, a PD-1×VEGF bispecific antibody

海报缩略图：Preliminary results from the first-in-human study of MK-2010, a PD-1×VEGF bispecific antibody
编号 CT057 展板 17 时间 4/20 09:00–12:00 区域 Section 50 主讲 Jennifer Pawlowski
分会场 First-in-Human Phase I Clinical Trials
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作者与单位

Jin Li1, Weizheng Kou2, Longhua Sun3, Yanqiu Zhao4, Rusen Zhao5, Baozhong Wang6, Shaozhang Zhou7, Juan Li8, Xuewen Liu9, Jun Zhao10, Dongqing Lv11, Gaofeng Li12, Junli Xue13, Yong Fang14, Daren Lin15, Jianhua Shi16, Yi Gong17, Xia Qin18, Yi Zuo19, Erik H. Knelson20, Weijuan Zhang19, Caicun Zhou13

1Shanghai GoBroad Cancer Hospital, China Pharmaceutical University, Shanghai, China,2The First Affiliated Hospital of Xinxiang Medical University, Xixiang, China,3The First Affiliated Hospital of Nanchang University, Nanchang, China,4The Affiliated Cancer Hospital of Zhengzhou University & Henan Cancer Hospital, Zhengzhou, China,5Zibo Municipal Hospital, Zibo, Shandong, China,6Liaocheng People's Hospital, Liaocheng, China,7Guangxi Medical University Cancer Hospital, Nanning, China,8Sichuan Cancer Hospital, Sichuan, China,9The Third Xiangya Hospital of Central South University, Changsha, China,10Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education/Beijing), Department I of Thoracic Oncology, Peking University Cancer Hospital and Institute, Beijing, China,11Taizhou Hospital of Zhejiang Province, Taizhou, China,12Yunnan Cancer Hospital, Kunming, China,13Shanghai East Hospital, Tongji University School of Medicine, Shanghai, China,14Sir Run Run Shaw Hospital, Hangzhou, China,15Jiangmen Central Hospital, Jiangmen, China,16Linyi Cancer Hospital, Linyi, China,17Chongqing University Cancer Hospital, Chongqing, China,18LaNova Medicines, Shanghai, China,19MSD China, Shanghai, China,20Merck & Co., Inc., Rahway, NJ

摘要 Abstract

Background: MK-2010 (LM-299) is a novel PD-1×VEGF bispecific antibody. We report initial safety and efficacy from the phase 1/2 MK-2010-001/LM299-01-102 study (NCT06650566). Methods: In the dose escalation cohort, participants (pts) with advanced solid tumors received MK-2010 Q2W (0.3-30 mg/kg) or Q3W (0.3-40 mg/kg). In the NSCLC randomization cohort (backfill), pts with advanced NSCLC with PD-L1 TPS ≥1% and no actionable genetic mutations were randomized to MK-2010 20 mg/kg or 30 mg/kg Q3W. Primary endpoints were dose-limiting toxicities (DLTs), AEs, and serious AEs. Secondary endpoints included PK and ORR per RECIST v1.1 by investigator review. ORR was assessed in pts first treated ≥6 wk before data cutoff (Dec 25, 2025). Results: 112 pts were treated; 40 pts in dose escalation and 72 pts in the NSCLC backfill (35 at 20 mg/kg and 37 at 30 mg/kg). In the backfill, 68% of pts received prior therapy; 60% with any anti-PD-(L)1 and 26% with any anti-VEGF therapy. Median follow-up was 7.9 mo (0-14.4) for the dose escalation cohort and 3.3 mo (range 0.6-5.5) for the backfill; median duration of therapy was 2.6 mo (range 0.03-9.8) and 2.1 mo (range 0.03-4.5), respectively. Two DLTs occurred overall (gr 3 hemoptysis in the dose escalation cohort at 3 mg/kg Q3W and gr 3 proteinuria in the 30 mg/kg backfill). Treatment-emergent AEs occurred in 95% of pts in the dose escalation cohort, 94% in the 20 mg/kg backfill, and 92% in the 30 mg/kg backfill; AEs were gr ≥3 in 53%, 23%, and 49%, respectively, and serious in 30%, 14%, and 32%, respectively. Treatment-related AEs (TRAEs) occurred in 95% of pts in the dose escalation cohort, 80% in the 20 mg/kg backfill, and 89% in the 30 mg/kg backfill; TRAEs were gr ≥3 in 40%, 17%, and 27%, respectively, and serious in 20%, 6%, and 8%, respectively. No grade 5 TRAEs were reported. One TRAE led to discontinuation (in the dose escalation cohort at 3 mg/kg Q3W). VEGF class-related AEs occurred in 51% of pts at 20 mg/kg and 49% at 30 mg/kg; gr ≥3 VEGF class-related AEs included hypertension (9% and 8%, respectively), bleeding events (0% and 5%), and proteinuria (0% and 5%). In the dose escalation cohort, unconfirmed responses were seen in 24% (4/17) of pts at ≥10 mg/kg Q3W and 22% (2/9) at ≥10 mg/kg Q2W. Unconfirmed ORR (n/N; 95% CI) for pts in the 20 mg/kg and the 30 mg/kg backfill arms was 30% (10/33; 16-49) and 28% (9/32; 14-47) overall, 55% (6/11; 23-83) and 44% (4/9; 14-79) in the 1L setting, and 18% (4/22; 5-40) and 22% (5/23; 7-44) in the 2L+ setting. The mean estimated half-life for MK-2010 at steady state was ~9 days. Conclusions: MK-2010 showed manageable safety across the tested dose levels and promising anti-tumor activity, including in both treatment-naïve and IO-refractory NSCLC. Enrollment is ongoing to further characterize the safety and efficacy of MK-2010.
利益披露 Disclosure
J. Li, Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA ). LaNova Medicines, Shanghai, China ). W. Kou, Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA ). LaNova Medicines, Shanghai, China ). L. Sun, Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA ). LaNova Medicines, Shanghai, China ). Y. Zhao, Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA ). LaNova Medicines, Shanghai, China ). R. Zhao, Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA ). LaNova Medicines, Shanghai, China ). B. Wang, Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA ). LaNova Medicines, Shanghai, China ). S. Zhou, Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA ). LaNova Medicines, Shanghai, China ). J. Li, Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA ). LaNova Medicines, Shanghai, China ). X. Liu, Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA ). LaNova Medicines, Shanghai, China ). J. Zhao, Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA ). LaNova Medicines, Shanghai, China ). D. Lv, Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA ). LaNova Medicines, Shanghai, China ). G. Li, Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA ). LaNova Medicines, Shanghai, China ). J. Xue, Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA ). LaNova Medicines, Shanghai, China ). Y. Fang, Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA ). LaNova Medicines, Shanghai, China ). D. Lin, Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA ). LaNova Medicines, Shanghai, China ). J. Shi, Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA ). LaNova Medicines, Shanghai, China ). Y. Gong, Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA ). LaNova Medicines, Shanghai, China ). X. Qin, LaNova Medicines, Shanghai, China Employment. Y. Zuo, Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA Employment, Stock Option. E. H. Knelson, Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA Employment, Stock Option. W. Zhang, Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA Employment, Stock Option. C. Zhou, Lily ). Sanofi ). BI ). LaNova Medicines, Shanghai, China ). Roche ). Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA ). Qilu ). Hengrui ). Innovent Biologics ). C-Stone ). LUYE Pharma ). Top Alliance Biosciences ). Amoy Diagnostics ).

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