Phase I/II trial of copanlisib in combination with nivolumab for microsatellite stable (MSS) colorectal cancer (CRC)

The findings presented at the 2024 AACR conference revealed that among patients diagnosed with PIK3Ca-mutated MSS mCRC (n = 22), three patients attained a partial response (PR). Additionally, one more patient with PIK3Ca-mutated mCRC maintained stable disease (SD). The study successfully achieved its primary endpoint of overall response rate at 6 months in the PIK3Ca-mutant subgroup, as responses were evident in a minimum of three patients.

Within the PIK3Ca wild-type subgroup (n = 17), one patient achieved a partial response (PR) despite lacking a PIK3Ca mutation. Additionally, four other patients in the same cohort exhibited stable disease (SD).

Conclusion

Copanlisib plus nivolumab elicited PRs in only a minority of patients, that subgroup experienced a significant clinical benefit.