Taselisib for PIK3CA-mutant HR+ advanced breast cancer lacks clinical utility in SANDPIPER

  • Ann Oncol

  • curated by Miriam Davis, PhD
  • Univadis Clinical Summaries
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Takeaway

  • Results of the SANDPIPER phase 3 randomized controlled trial (RCT) show that taselisib for PIK3CA-mutant hormone receptor (HR)-positive HER2-negative advanced breast cancer is only modestly effective and has numerous safety problems.

Why this matters

  • Authors: taselisib has "no clinical utility." 

Study design

  • Placebo-controlled RCT comparing taselisib (4 mg) or placebo plus fulvestrant (500 mg) in postmenopausal women with disease recurrence/progression during/after an aromatase inhibitor.
  • Primary outcome: investigator-assessed PFS in patients with PIK3CA-mutant tumors.
  • Funding: F. Hoffmann-La Roche Ltd.

Key results

  • PFS was longer with taselisib vs placebo:
    • 7.4 (95% CI, 7.26-9.07) vs 5.4 (95% CI, 3.68-7.29) months. 
    • Stratified HR: 0.70 (P=.0037).
  • Versus the placebo group, the taselisib group had higher rates of serious adverse events (32% vs 8.9%), discontinuations (16.8% vs 2.3%), and dose reductions (36.5% vs 2.3%).

Limitations

  • Study period too short to evaluate OS.