Takeaway
- Adding nelipepimut-S (NPS) to trastuzumab significantly extended disease-free survival (DFS) in a phase 2b study of patients with triple-negative breast cancer (TNBC).
Why this matters
- No targeted therapies approved for TNBC.
- Warrants confirmatory phase 3 trial in TNBC.
Study design
- Final analysis of multicenter, single-blinded phase 2b trial in 275 patients with HER2 low-expressing tumors, randomly assigned to granulocyte macrophage-colony stimulating factor (GM-CSF) with placebo or NPS; all received trastuzumab every 3 weeks for 1 year.
- GM-CSF or NPS+GM-CSF was given every 3 weeks for 6 cycles, starting with the third trastuzumab dose, and boosters every 6 months x 4.
- Primary endpoint: DFS at 24 months.
- Funding: George E. Peoples.
Key results
- Recurrences
- Median follow-up: 24.7 months.
- Intention-to-treat (ITT)-All patients: No significant difference between arms.
- ITT-TNBC patients:
- NPS+trastuzumab (n=53): 7.5%.
- Trastuzumab (n=44): 26.7%.
- P=.01.
- DFS
- ITT-All patients: No significant difference in 24-, 36-month DFS between arms.
- ITT-TNBC patients:
- NPS+trastuzumab (n=53)
- 24 months: 92.6%.
- 36 months: 82.3%.
- Trastuzumab (n=44)
- 24 months: 70.2%.
- 36 months: 70.2%.
- P=.013, HR 0.26.
- NPS+trastuzumab (n=53)
- NPS+trastuzumab safe; no notable differences between arms.
Limitations
- Unclear if TNBC subgroup analysis planned/post-hoc.
- Data on memory attributes of NPS-induced T-cells could help clarify whether secondary prevention provided.
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