澳大利亚生物技术公司Amplia Therapeutics与全球制药巨头礼来公司达成合作协议，将联合开展一项临床试验，评估两款候选药物的组合疗法用于治疗晚期非小细胞肺癌[1]。这项Phase 1b/2b试验将结合Amplia开发的FAK抑制剂narmafotinib与礼来的KRAS G12C抑制剂olomorasib，计划于2026年晚期启动，试验地点覆盖澳大利亚和美国[1]。
该试验针对携带KRAS G12C突变的患者，这种突变发生在约13%的非小细胞肺癌患者中[1]。试验将评估这一新型组合疗法作为晚期患者二线治疗的安全性和有效性[1]。礼来将为试验提供olomorasib药物，无需付费[1]。
Amplia首席执行官Chris Burns表示："FAK和KRAS抑制的结合可以带来改善的治疗效果"[1]。根据Amplia此前的ACCENT研究数据，narmafotinib与化疗联合的缓解率为36%，中位总生存期为11.1个月，完全缓解率为7.8%[1]。此外，美国FDA已授予narmafotinib针对胰腺癌和特发性肺纤维化的孤儿药指定，以及胰腺癌的快速通道资格[1]。
全球非小细胞肺癌市场目前价值约31亿美元，预计到2033年将增长至超过60亿美元[1]。
Australian biotechnology company Amplia Therapeutics has entered into a clinical trial collaboration with pharmaceutical giant Eli Lilly to evaluate a novel combination therapy for advanced non-small cell lung cancer [1]. The trial will combine Amplia's FAK inhibitor narmafotinib with Lilly's KRAS G12C inhibitor olomorasib, targeting patients with KRAS G12C mutations, which occur in approximately 13% of non-small cell lung cancer patients [1]. The Phase 1b/2b study is designed to assess the safety and efficacy of this dual-inhibitor approach as a second-line treatment and is scheduled to launch in late 2026 [1].
The global non-small cell lung cancer market is currently valued at approximately US$31 billion (A$44 billion) and is projected to exceed US$60 billion (A$86 billion) by 2033 [1]. Eli Lilly will supply olomorasib for the trial at no cost [1]. The trial will be conducted across multiple sites in Australia and the United States [1]. Amplia Chief Executive Chris Burns stated that "the combination of FAK and KRAS inhibition has the potential to deliver improved therapeutic benefit" [1]. Prior research from Amplia's ACCENT study demonstrated that narmafotinib combined with chemotherapy achieved a response rate of 36%, a median overall survival of 11.1 months, and a complete response rate of 7.8% [1]. The FDA has previously granted narmafotinib orphan drug designations for pancreatic cancer and idiopathic pulmonary fibrosis, as well as fast-track status for pancreatic cancer [1].