PANOVA-3
Tumor Treating Fields with gemcitabine and nab-paclitaxel for locally advanced pancreatic adenocarcinoma (PANOVA-3)
Phase 3N = 571NCT03377491
- Population
- Newly diagnosed unresectable locally advanced pancreatic adenocarcinoma
- Design
- Global, randomised, open-label phase 3 trial: gemcitabine 1,000 mg/m2 and nab-paclitaxel 125 mg/m2 (days 1, 8, 15 of a 28-day cycle) with or without tumour treating fields (alternating electric fields delivered by a device) in newly diagnosed unresectable locally advanced pancreatic adenocarcinoma. Primary endpoint overall survival.
- Primary endpoint
- OS
- Arms
- TTFields plus gemcitabine and nab-paclitaxel (experimental, n = 285): Tumour treating fields with gemcitabine 1,000 mg/m2 and nab-paclitaxel 125 mg/m2
- Gemcitabine and nab-paclitaxel (control, n = 286): Gemcitabine 1,000 mg/m2 and nab-paclitaxel 125 mg/m2
- People
- Babiker HM
OSHR 0.82 (95% CI 0.68–0.99)Δ median OS+2 months
Show the numbers
| Endpoint | Analysis | TTFields plus gemcitabine and nab-paclitaxel | Gemcitabine and nab-paclitaxel | Effect |
|---|---|---|---|---|
| OSITT (all randomised patients, 571) | primaryBabiker 2025 | median 16.2 months (15–18) | median 14.2 months (12.8–15.4) | HR 0.82 (95% CI 0.68–0.99)P=.039 |
| Endpoint | Analysis | TTFields plus gemcitabine and nab-paclitaxel | Gemcitabine and nab-paclitaxel | Effect |
|---|---|---|---|---|
| OSITT (all randomised patients, 571) | primaryBabiker 2025 | median 16.2 months (15–18) | median 14.2 months (12.8–15.4) | HR 0.82 (95% CI 0.68–0.99)P=.039 |
Data table
| Endpoint | HR | 95% CI |
|---|---|---|
| OS | 0.82 | 0.68–0.99 |
- TTFields plus gemcitabine and nab-paclitaxel (experimental)
- Gemcitabine and nab-paclitaxel (control)
Median-only curves assume a constant hazard (exponential) and fit plateaus, as seen with some immunotherapies, poorly.
Data table (modelled values)
| Months | TTFields plus gemcitabine and nab-paclitaxel | Gemcitabine and nab-paclitaxel |
|---|---|---|
| 0 | 100.0% | 100.0% |
| 10 | 65.2% | 61.4% |
| 20 | 42.5% | 37.7% |
| 30 | 27.7% | 23.1% |
| 41 | 17.3% | 13.5% |