Encorafenib

一、新药快讯 1、美国FDA加速批准康奈非尼治疗肠癌，61%的患者病灶缩小 2024年12月20日，美国食品药品监督管理局FDA加速批准了康奈非尼上市，具体适应症为存在BRAF基因V600E突变的转移性结直肠癌，具体用药方案为康奈非尼联合西妥昔单抗和标准化疗方案。在之前的临床试验中，这种组合用药取得了61%的客观缓解率，也就是61%的患者肿瘤病灶缩小超过了30%，平均缓解持续时间为13.9个月，这个方案也是目前唯一获批用于BRAF基因肠癌的治疗方案。 2、维迪西妥单抗联合拉帕替尼、卡培他滨治疗HER2阳性乳腺癌 2024年第47届圣安东尼奥乳腺癌研讨会上，中国医学科学院肿瘤医院王佳玉教授团队报道了维迪西妥单抗与拉帕替尼加卡培他滨在HER2阳性晚期乳腺癌伴肝转移患者中的疗效的研究。这是全球第一个证实HER2抗体偶联药在肝转移乳腺癌的临床研究。结果表明联合用药改善了患者的无进展生存期，疾病进展或死亡风险降低了44%，中位总生存期数据还没成熟。 3、HER2抗体偶联药ARX788治疗晚期乳腺癌研究数据公布 2024年第47届圣安东尼奥乳腺癌研讨会上，复旦大学附属肿瘤医院胡夕春教授进行了一项口头报道，对于一项关于HER2抗体偶联药ARX788的三期临床试验数据进行了分析。研究纳入了441名患者，这些患者都是之前使用曲妥珠单抗和紫衫烷治疗失败的晚期HER2阳性乳腺癌，中期的分析表明研究达到了预期的结果，且安全性分析也发现ARX788引起的不良反应可控。更为详细的研究结果将会在后续肿瘤学大会进一步公布。 二、新药快讯 1、晚期肝癌患者免疫治疗耐药后，使用仑伐替尼仍然有效 2024年欧洲肿瘤内科学会亚洲大会上，研究者公布了一项关于仑伐替尼的临床研究，如果晚期肝细胞癌患者一线治疗失败之后，再次使用多靶点抗血管生成靶向药仑伐替尼治疗，患者仍然可以控制肿瘤，84%的患者用药后肿瘤病灶停止进展，12%的患者达到临床部分缓解，平均控制肿瘤稳定的时间为5.4个月，同时副作用较为可控。

Pfizer’s Braftovi (encorafenib) regimen has been granted accelerated approval by the US Food and Drug Administration (FDA) to treat metastatic colorectal cancer (mCRC). The drug has been authorised for use in combination with Erbitux (cetuximab) and mFOLFOX6 (fluorouracil, leucovorin and oxaliplatin) to treat mCRC in patients with a BRAF V600E mutation. Until now, there were no approved biomarker-driven therapies specifically indicated for patients with previously untreated BRAF V600E-mutant mCRC. Colorectal cancer is the third most common type of cancer globally, with approximately 1.8 million new cases of the disease diagnosed in 2022. BRAF mutations are estimated to occur in up to 10% of patients with metastatic cases of the disease and are associated with a poor prognosis. Braftovi is an oral small molecule kinase inhibitor designed to target the most common BRAF mutation, BRAF V600E. Pfizer has exclusive rights to the drug in the US, Canada, Latin America, the Middle East and Africa, while licences are also held by Ono Pharmaceutical, Medison and Pierre Fabre. The FDA’s decision was supported by phase 3 results from the ongoing BREAKWATER trial in previously untreated mCRC patients with a BRAF V600E mutation. The Braftovi regimen was associated with a statistically significant improvement over standard of care in one of the dual primary endpoints of confirmed overall response rate (ORR), with an ORR of 61% for Braftovi in combination with Erbitux and mFOLFOX6 versus 40% for chemotherapy, with or without bevacizumab. The median duration of response was 13.9 months for the Braftovi combination regimen versus 11.1 months for chemotherapy, and the safety profile of the regimen was consistent with the known safety profile of each respective agent. Chris Boshoff, chief oncology officer, executive vice president at Pfizer, said: “With [this] accelerated approval of the Braftovi regimen, patients with mCRC with a BRAF V600E mutation now have a first-line treatment option, which contains a targeted therapy specifically for a mutation that is driving their cancer.” In line with the FDA’s accelerated approvals pathway, continued approval is contingent upon the verification of clinical benefit. The BREAKWATER data is also being discussed with other regulatory authorities globally to support potential future applications for the Braftovi combination regimen in this indication.