Rapid Readouts: Results from the Phase 3 CHRONOS-3 Trial for Relapsed iNHL

Tycel J. Phillips, MD, discusses data from the following presentation:

• Results from CHRONOS-3: a phase 3 study of copanlisib plus rituximab versus placebo plus rituximab in patients with relapsed iNHL. (Matasar MJ et al. AACR Annual Meeting 2021. Abstract CT001)
  • The CHRONOS-3 study (NCT02367040) is a randomized, double-blinded, placebo-controlled, phase 3 study.
  • Copanlisib plus rituximab resulted in a 48% reduction in the risk of disease progression or death versus placebo plus rituximab in patients with relapsed iNHL.
  • The overall response rate (ORR) was significantly increased with copanlisib plus rituximab compared with placebo plus rituximab, with improvements in progression-free survival, ORR, and complete response rate (CRR) seen across all iNHL subtypes.
  • Copanlisib plus rituximab demonstrated a manageable safety profile, consistent with previous reports of copanlisib and rituximab as monotherapies.
  • The addition of copanlisib to standard rituximab treatment demonstrated broad and superior efficacy to rituximab monotherapy in patients with relapsed iNHL.
  • Copanlisib is the first PI3K inhibitor to be safely combined with rituximab and the first to demonstrate broad superior efficacy in combination with rituximab in all iNHL histologies.
  • Duration of response and durability of CRR with copanlisib plus rituximab in patients with relapsed iNHL will be important factors impacting clinical practice.
  • Overall, copanlisib plus rituximab represents a new treatment option for patients with relapsed disease across all subtypes of iNHL.