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<p><i>PIK3CA</i> is mutated in ~15% of colorectal cancers (CRC). PI3K regulates immunity, inhibition potentially enhances anti-tumor immunity. We launched a phase 1/2 trial of copanlisib (PIK3CA inhibitor) and nivolumab (anti-PD-1) in metastatic microsatellite stable CRC (NCT03711058): Cohort A: <i>PIK3CA</i>wt (<i>n</i> = 17) and Cohort B: <i>PIK3CA</i>mut (<i>n</i> = 22). Copanlisib/nivolumab is well tolerated with recommended phase 2 dose of nivolumab 480 mg day 1 and copanlisib 60 mg days 1/8/15 of a 28-day cycle. Primary endpoint of objective response rate at 6 months was not met with Cohort A: 0/17 and Cohort B: 2/22 having 6-month treatment response. Secondary endpoints are median progression-free survival (Cohort A: 1.7 months; Cohort B: 1.6 months), median overall survival (Cohort A: 8.5 months; Cohort B: 6.7 months), duration of response (Cohort A: 13.1 months; Cohort B: 17 months) and 6-month disease control rate (Cohort A: 2/17; Cohort B: 3/22). Secondary endpoints were not statistically different between these cohorts.</p>

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Copanlisib in combination with nivolumab formicrosatellite stable colorectal cancer: a phase 1/2 trial

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2026年7月23日

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  • Eric S. Christenson,
  • Jeremiah A. Wala,
  • Rose Parkinson,
  • Natalie B. Collins,
  • Christopher Jakubowski,
  • Jia-Ren Lin,
  • Kristin Qian,
  • Jiayun Lu,
  • Hao Wang,
  • Won Jin Ho,
  • Sabrina Chan,
  • Ewa Kulikowicz,
  • Rachel Klein,
  • Yvette Cetasaan,
  • Emma Johnson,
  • Maureen Berg,
  • Jeffrey A. Meyerhardt,
  • Dung T. Le,
  • Benjamin L. Schlechter,
  • Ilene Browner,
  • Lei Zheng,
  • Harshabad Singh,
  • Ross Donehower,
  • Elizabeth M. Jaffee,
  • Peter K. Sorger,
  • Marios Giannakis,
  • Nilofer Azad

摘要

PIK3CA is mutated in ~15% of colorectal cancers (CRC). PI3K regulates immunity, inhibition potentially enhances anti-tumor immunity. We launched a phase 1/2 trial of copanlisib (PIK3CA inhibitor) and nivolumab (anti-PD-1) in metastatic microsatellite stable CRC (NCT03711058): Cohort A: PIK3CAwt (n = 17) and Cohort B: PIK3CAmut (n = 22). Copanlisib/nivolumab is well tolerated with recommended phase 2 dose of nivolumab 480 mg day 1 and copanlisib 60 mg days 1/8/15 of a 28-day cycle. Primary endpoint of objective response rate at 6 months was not met with Cohort A: 0/17 and Cohort B: 2/22 having 6-month treatment response. Secondary endpoints are median progression-free survival (Cohort A: 1.7 months; Cohort B: 1.6 months), median overall survival (Cohort A: 8.5 months; Cohort B: 6.7 months), duration of response (Cohort A: 13.1 months; Cohort B: 17 months) and 6-month disease control rate (Cohort A: 2/17; Cohort B: 3/22). Secondary endpoints were not statistically different between these cohorts.