达沙替尼+曲美替尼治疗BRAF突变的晚期肺癌:有效率63.2%,生存期明显延长
  • BRF113928研究初始评价Dabrafenib (D)单药治疗(78例)或D + Trametinib (T)联合治疗(57例)的疗效和安全性;
  • 初步分析显示ORR:D=33.3%、D+T=63.2%,D+T组的DOR为9个月;
  • BRF113928研究数据更新:中期随访时间为16.2个月,代表10个月后续随访时间;
  • D组中期OS为12.7个月(57例死亡),D+T组中期OS为18.2个月(33例死亡);
  • 更新数据表明,针对BRAFV600E突变的NSCLC患者,D+T联合治疗疗效持久并可延长患者生存。
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Updated survival of patients (pts) with previously treated BRAF V600E–mutant advanced non-small cell lung cancer (NSCLC) who received dabrafenib (D) or D + trametinib (T) in the phase II BRF113928 study

一个BRF113928二期临床实验:Dabrafenib (D)单药治疗或D + Trametinib (T)联合治疗BRAF V600E突变的晚期非小细胞肺癌(NSCLC)的患者生存期更新

2017-06-03

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Background: BRAF V600E mutations occur in 1% to 2% of lung adenocarcinomas and act as oncogenic drivers. Initial cohorts of the BRF113928 (NCT01336634) trial evaluated efficacy and safety of D monotherapy (cohort A; n = 78) or D + T (cohort B; n = 57) in pts with previously treated BRAFV600E–mutant metastatic NSCLC. At primary analysis, overall response rates (ORRs) were 33.3% and 63.2% in pts who received D or D + T, respectively. Furthermore, durable response (median duration of response [DOR], 9.0 mo) was observed in D + T pts. Here, we present an updated survival analysis based on additional follow-up
Methods: In this phase 2 trial, 2 cohorts (A and B) of pts with previously treated metastatic BRAFV600E–mutant NSCLC were enrolled sequentially. The primary endpoint was investigator-assessed ORR. Secondary efficacy endpoints included progression-free survival (PFS), DOR, and overall survival (OS). D and T were dosed orally at the established phase 2 dose of D 150 mg twice daily and T 2 mg once daily.
Results: This updated analysis had a median follow-up of 16.2 mo, which represented an additional 10 mo of follow-up. Median OS was 12.7 mo (95% CI, 7.3-16.3) with 57 deaths reported for pts treated with D monotherapy and 18.2 mo (95% CI, 14.3-not estimable [NE]) with 33 deaths reported for pts treated with D + T. Detailed efficacy results are presented in the table. Investigator-assessed ORR, DOR, and PFS were supported by independent review committee assessments. No new safety signals were observed for D + T.
Conclusions: This update of the BRF113928 study confirms that durable responses and encouraging survival were achieved with combination D + T in pts with BRAFV600E–mutant NSCLC.

All Authors:
David Planchard

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