The phase 3 BEACON CRC study demonstrated the survival benefits of encorafenib and cetuximab, with or without binimetinib (the BEACON triplet or doublet regimen), for -mutant metastatic colorectal cancer (mCRC). This expanded access program (EAP) and subsequent follow-up study assessed the efficacy and safety of the BEACON triplet regimen in Japanese patients with -mutant mCRC. The EAP was an open-label, single-arm study including Japanese patients with -mutant mCRC whose disease progressed after 1 to 2 prior regimens. The patients received the BEACON triplet regimen with 28-day cycles. The subsequent follow-up study assessed the survival outcomes following EAP completion. Safety was assessed only during the EAP. Among the 86 enrolled patients, 81 received the BEACON triplet regimen. The objective response rate and median progression-free survival were 27.6% (95% confidence interval [CI], 18.0%-39.1%) and 5.26 (95% CI, 4.14-5.52) months, respectively. Grade 3 to 4 adverse events and treatment-related adverse events occurred in 43.2% and 28.4% of patients, respectively. No new safety signals were observed during the EAP. Among 58 patients with confirmed survival at EAP completion, 57 were included in the follow-up study. With a median observation period of 9.17 months through the EAP and follow-up study, the median overall survival was 10.38 (95% CI, 9.00-16.16) months. The efficacy and safety of the BEACON triplet regimen in Japanese patients with -mutant mCRC were consistent with those reported in the BEACON CRC trial, supporting its use as a standard treatment for pretreated patients with -mutant mCRC.

中文翻译：

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Encorafenib、Binimetinib 和 Cetuximab 治疗 BRAFV600E 突变型转移性结直肠癌的安全性和有效性：日本扩大使用计划的结果

3 期 BEACON CRC 研究证明了 encorafenib 和西妥昔单抗联合或不联合 binimetinib（BEACON 三联或双联方案）对于突变型转移性结直肠癌 (mCRC) 的生存益处。这项扩大准入计划 (EAP) 和随后的后续研究评估了 BEACON 三联方案在日本 β 突变 mCRC 患者中的有效性和安全性。 EAP 是一项开放标签、单组研究，纳入的日本突变型 mCRC 患者在接受 1 至 2 种既往治疗后病情出现进展。患者接受 BEACON 三联疗法，周期为 28 天。随后的后续研究评估了 EAP 完成后的生存结果。仅在 EAP 期间评估安全性。在 86 名入组患者中，81 名接受了 BEACON 三联疗法。客观缓解率和中位无进展生存期分别为 27.6%（95% 置信区间 [CI]，18.0%-39.1%）和 5.26（95% CI，4.14-5.52）个月。 3至4级不良事件和治疗相关不良事件分别发生在43.2%和28.4%的患者中。 EAP 期间没有观察到新的安全信号。在 58 名 EAP 完成时确认存活的患者中，有 57 名被纳入随访研究。通过EAP和随访研究，中位观察期为9.17个月，中位总生存期为10.38（95% CI，9.00-16.16）个月。 BEACON 三联疗法在日本 β-突变型 mCRC 患者中的疗效和安全性与 BEACON CRC 试验中报告的结果一致，支持其用作经治疗的 β-突变型 mCRC 患者的标准治疗。