A Phase 3 Randomized, Open-label Study to Evaluate the Efficacy and Safety of Olaparib Alone or in Combination With Bevacizumab Compared to Bevacizumab With 5-FU in Participants With Unresectable or Metastatic Colorectal Cancer Who Have Not Progressed Following First-line Induction of FOLFOX With Bevacizumab (LYNK-003)

• Metastatic or unresectable colorectal adenocarcinoma
• Has not progressed after first-line induction of at least 6 cycles of FOLFOX with bevacizumab
  • May have received prior adjuvant/neoadjuvant chemo for CRC as long as it was completed at least 6 months prior to initiation of metastatic FOLFOX-bev
• Has experienced unacceptable toxicity to oxaliplatin that required the discontinuation of oxaliplatin (such as neurotoxicity)
• Must be randomized within a minimum of 2 weeks and a maximum of 6 weeks after their last dose of FOLFOX+bev
• ECOG PS 0-1
• No known CNS disease
• No known HIV/HBV/HCV
• No clinically significant bleeding within 28 days
• No uncontrolled hypertension, nephrotic syndrome, GI perforation
• No prior tx with olaparib or other PARP inhibitor

• Primary
  • PFS
• Secondary
  • OS
  • ORR
  • DoR
  • Safety