Aakash Desai, Associate Professor at UAB O’Neal Cancer Center, shared on LinkedIn:
“After osimertinib, EGFR-mutant NSCLC has gone from ‘platinum-pemetrexed’ to three positive phase 3 trials against it. All three won on PFS. None has a significant OS win yet.
HARMONi
Lancet Oncology, global:
- ivonescimab + chemotherapy,
- mPFS 6.8 vs 4.4 mo (HR 0.52),
- OS 16.8 vs 14.0 mo (HR 0.79, 95% CI 0.62–1.01).
Title: Ivonescimab plus chemotherapy versus placebo plus chemotherapy in patients with advanced EGFR-mutated non-small-cell lung cancer after disease progression on EGFR tyrosine kinase inhibitor therapy (HARMONi): a multicentre, randomised, double-blind, phase 3 trial
Authors: Xiuning Le, Antonio Passaro, Yuanyuan Zhao, Yan Huang, Janessa Laskin, Delvys Rodriguez-Abreu, Antonio Calles, Lyudmila Bazhenova, Giuseppe Lo Russo, Natasha B Leighl, Federico Cappuzzo, Nicolas Girard, Sanjay Popat, Wenfeng Fang, Yongzhong Luo, Wenting Li, Zhiyong He, Hui Zhao, Mingjun Li, Qibin Song, Hongyun Zhao, Haidar El Darsa, Isabelle Monnet, Manuel Cobo Dols, Rosario García Campelo, Robert Jotte, David Berz, Alexander Spira, Maurice Pérol, Misako Nagasaka, Howard West, Lori Styles, Jianling Li, Fong Clow, Jonathan Goldman, Li Zhang.
Read the full article.
PANKU-Lung01
Lancet, China:
- iza-bren (EGFR×HER3 bispecific ADC),
- mPFS 11.1 vs 5.7 mo (HR 0.40),
- G≥3 TRAEs 79 vs 62%.
Title: Izalontamab brengitecan versus platinum-based chemotherapy in EGFR-mutated advanced non-squamous non-small-cell lung cancer after progression on third-generation EGFR tyrosine kinase inhibitors (PANKU-Lung01): a multicentre, randomised, open-label, phase 3 trial in China
Authors: Shaodong Hong, Ting Zhou, Xue Hou, Xiangjiao Meng, Zhihuang Hu, Wei Zheng, Jiuwei Cui, Yongzhong Luo, Lin Wu, Meijuan Huang, Haipeng Xu, Jie Hu, Yanqiu Zhao, Wenxiu Yao, Yonggui Hong, Jun Cai, Yu Zhang, Chunxia Su, Conghua Xie, Ruoyu Wang, Xiang Li, Qiong He, Liang Zhanga, Ruiling Ning, Daren Lin, Tongmei Zhang, Tienan Yi, Liqiang Zhong, Siyuan Huang, Hui Zhao, Jian Fang, Qing Bu, Bihui Li, Zhiye Zhang, Meiqi Shi, Jianhua Shi, Zhiping Deng, Yi Zhu, Hai Zhu, Sa Xiao, Lei Yang, Ni Song, Wenfeng Fang, Li Zhang, Yunpeng Yang.
Read the full article.
HERON-Lung01
Lancet, China, interim:
- HER3 ADC ruzaltatug rezetecan,
- mPFS 8.3 vs 5.4 mo (HR 0.47).
Title: Ruzaltatug rezetecan versus chemotherapy for EGFR-mutated advanced non-small-cell lung cancer progressing after EGFR tyrosine kinase inhibitor therapy (HERON-Lung01): interim analysis of a randomised, open-label, phase 3 trial in China
Authors: Chong-Rui Xu, Yan Zhang, Guinan Lin, Haiyong Wang, Qiming Wang, Dingzhi Huang, Yan Yu, Jin Zhou, Hua Zhong, Lin Wu, Lingxiang Liu, Jianchun Duan, Zhiyi He, Yongzhong Luo, Hongxu Liu, Bi Chen, Xinmin Yu, Feng Xue, Qian Chu, Sanxing Guo, Runxiang Yang, Jia Zhong, Haifeng Liu, Longhua Sun, Xiaorong Dong, Haichuan Su, Peng Zhang, Bin Yang, Sisi He, Yuanyuan Ji, Lixin Wan, Xinghua Han, Jingyu Zhang, Fei Qiu, Lulu Yang, Wei Shi, Yi-Long Wu.
Read the full article.
The FDA decision on ivonescimab is due Nov 14. Bispecific, bispecific ADC, or HER3 ADC: how should we sequence them, and is PFS alone enough? Of course, as these therapies get approved and enter the clinic, the experience may weigh on selection too!”
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