Neoadjuvant stereotactic body radiation therapy with durvalumab and oleclumab in ER(+)HER2(-) breast cancer: a randomized phase 2 trial.
Combining radiation with two immunotherapy drugs significantly improved complete response rates in high-risk hormone-receptor-positive breast cancer, especially in tumors previously resistant to single immunotherapy.
This randomized phase 2 trial (Neo-CheckRay) enrolled 147 high-risk ER+HER2- early breast cancer patients to evaluate immune-modulating SBRT (3×8 Gy) combined with the anti-PD-L1 agent durvalumab and/or anti-CD73 agent oleclumab. In the per-protocol MammaPrint High Risk population, pCR rates were 16.3%, 32.6%, and 35.6% for no-ICI, single-ICI, and double-ICI arms respectively (P=0.040), with dramatic benefit in otherwise refractory PD-L1-negative tumors.
What the study was
- Study design
- Randomized multicenter phase 2 trial (3 arms, Neo-CheckRay)
- Population
- High-risk ER+HER2- early breast cancer patients (female, stage I-III)
- Sample size
- 147
- Category
- Treatment Innovation
- Maturity
- Potentially Practice-Changing
- Journal
- Nature Medicine
Why it surfaced
First randomized evidence that iSBRT converts immune-cold ER+HER2- tumors to an inflamed phenotype enabling ICI response; near-tripling of pCR in PD-L1-negative patients is clinically transformative in a major breast cancer subtype. Nature Medicine publication.
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