COLUMBIA-1: a randomised study of durvalumab plus oleclumab in combination with chemotherapy and bevacizumab in metastatic microsatellite-stable colorectal cancer

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2024年7月25日

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Neil H. Segal,
Jeanne Tie,
Scott Kopetz,
Michel Ducreux,
Eric Chen,
Rodrigo Dienstmann,
Antoine Hollebecque,
Matthew J. Reilley,
Elena Elez,
Jan Cosaert,
Jason Cain,
Yee Soo-Hoo,
Nicola Hewson,
Zachary A. Cooper,
Rakesh Kumar,
Josep Tabernero

摘要

Background

To determine whether the addition of durvalumab (anti-PD-L1) and oleclumab (anti-CD73) to standard-of-care treatment (FOLFOX and bevacizumab) enhances the anti-tumour effect in patients with metastatic colorectal cancer (mCRC).

Methods

COLUMBIA-1 (NCT04068610) was a Phase Ib (feasibility; Part 1)/Phase II (randomised; Part 2) trial in patients with treatment-naïve microsatellite stable mCRC. Patients in Part 2 were randomised to receive standard-of-care (control arm) or standard-of-care plus durvalumab and oleclumab (experimental arm). Primary objectives included safety and efficacy.

Results

Seven patients were enrolled in Part 1 and 52 in Part 2 (n = 26 in each arm). Grade ≥3 treatment-emergent adverse events (TEAE) occurred in 80.8% and 65.4% of patients in the control and experimental arms of Part 2, respectively, with 26.9% and 46.3% experiencing serious TEAEs. The confirmed objective response rate (ORR) was numerically higher in the experimental arm compared with the control arm (61.5% [95% confidence interval (CI), 40.6–79.8] vs 46.2% [95% CI, 26.6–66.6]) but did not meet the statistically significant threshold in either arm.

Conclusion

The safety profile of FOLFOX and bevacizumab in combination with durvalumab and oleclumab was manageable; however, the efficacy results do not warrant further development of this combination in patients with microsatellite stable mCRC.

Registration

NCT04068610.