NAPOLI 3
The first head-to-head trial of the two chemotherapy backbones, won narrowly by the four-drug regimen.
770 patients. OS 11.1 vs 9.2 months (HR 0.84, p=0.04); PFS 7.4 vs 5.6 months (HR 0.69). Led to FDA approval of NALIRIFOX (February 2024). Critics note the absence of a mFOLFIRINOX arm.
Setting
First-line metastatic PDAC: NALIRIFOX vs gemcitabine + nab-paclitaxel
Phase
Phase 3
Sponsor
Ipsen
Registry
Headline result
OS HR 0.84; PFS HR 0.69.
Reported
2023
Enrolled
770
Replication
Consistent in direction with PRODIGE 4/ACCORD 11 (FOLFIRINOX vs gemcitabine); no direct FOLFIRINOX comparison.
In plain words
What these results mean for people, not percentages
Overall survivalprimarysurvival endpoint
- Median 11.1 vs 9.2 months with NALIRIFOX compared with Gemcitabine + nab-paclitaxel; about 1.9 months longer for half the group.
- A median is a midpoint: half the people did better than this and half did worse, so it is not a prediction for any one person.
- Put another way, the treated group had about 17 percent lower chance of the event at any given time (hazard ratio 0.83, likely range 0.7 to 0.99).
- Overall survival counts deaths from any cause, so it is the most direct measure of whether a treatment helps people live longer.
- These results apply to the people the trial enrolled: First-line metastatic PDAC: NALIRIFOX vs gemcitabine + nab-paclitaxel. People in a different situation may not see the same effect.
Numbers are from the trial as recorded here; see the source links in the table below. This is orientation, not medical advice: ask your team how closely the trial population matches you.
770 participants enrolled.
Overall survivalprimary
HR 0.83 (0.7–0.99) · p = 0.036
NALIRIFOX
11.1 mo
Gemcitabine + nab-paclitaxel
9.2 mo
| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Overall survivalprimary | NALIRIFOX | 383 | 11.1 months | 0.83 (0.7–0.99) | 0.036 | link |
| Gemcitabine + nab-paclitaxel | 387 | 9.2 months |
Replication
Consistent in direction with PRODIGE 4/ACCORD 11 (FOLFIRINOX vs gemcitabine); no direct FOLFIRINOX comparison.