Phase III PANOVA-3 trials show that Tumour-Treating Fields Improve Overall Survival

Final data from the Phase 3 PANOVA-3 study of tumour treating fields  (TTFields – electric fields that disrupt cancer cell division leading to cell death) with gemcitabine and nab-paclitaxel, a randomised, open-label trial (NCT03377491) for locally advanced pancreatic ductal adenocarcinoma (PDAC), shows a statistically significant overall survival (OS) benefit. Patients who received the combination of TTFields added to gemcitabine and nab-paclitaxel in first-line therapy had an improvement of two months in overall survival compared with gemcitabine/nab-paclitaxel alone. It was also observed no additive systemic toxicity and a statistically significant pain-free survival benefit.

PANOVA-4 trial (NCT06390059) is currently ongoing in Europe (Czechia, Germany, Spain, and Switzerland) to study TTFields combined with atezolizumab immunotherapy, gemcitabine, and nab-paclitaxel as first-line treatment for metastatic PDAC.

References

https://clinicaltrials.gov/study/NCT03377491

https://meetings.asco.org/abstracts-presentations/245458

https://clinicaltrials.gov/study/NCT06390059

CASSANDRA trial: Combination PAXG  and mFOLFIRINOX for resectable or borderline resectable PDAC

The ongoing Phase 3 CASSANDRA trial  (NCT04793932)  shows that patients with resectable or borderline PDAC,  receiving a neoadjuvant (pre-operative) treatment of cisplatin (P), nab-paclitaxel (A), capecitabine (X), and gemcitabine (G), known as PAXG regimen, improved extended event -free survival (EFS) compared with the modified FOLFIRINOX (mFOLFIRINOX) regimen (fluorouracil, irinotecan, and oxaliplatin). Event-free survival (EFS) means the absence of disease progression, recurrence, two consecutive CA 19-9 increases of 20% or more separated by at least four weeks, unresectability, intraoperative metastasis, or death. After about 2 years of follow-up, patients who received the PAXG treatment stayed free from cancer problems for a median of 16 months, while those who got mFOLFIRINOX had a median EFS  of about 10 months.

References

https://www.clinicaltrials.gov/study/NCT04793932

https://meetings.asco.org/abstracts-presentations/243684

Understanding the TEDOPAM Clinical Trial: a new vaccine for pancreatic cancer

The Phase 2 TEDOPAM clinical trial (NCT03806309), also known  GERCOR D17-01 PRODIGE 63,  focuses on testing a novel cancer vaccine called OSE2101 (Tedopi®) for patients with advanced or metastatic pancreatic cancer. This trial included patients who were HLA‑A2 positive (a genetic marker) and had not seen cancer progression after receiving eight cycles of FOLFIRINOX chemotherapy

The main goal of TEDOPAM trial was to see if patients who received FOLFIRI (irinotecan, leucovorin, and 5‐fluorouracil) plus the vaccine  OSE2101 could achieve a one‑year overall survival (OS) rate of 50%, compared to a baseline target of 25%. Additional goals included how long patients lived without cancer progression, patients’ quality of life, safety and side effects

Results with 107 patients showed that the group who received the vaccine OSE2101 and FOLFIRI (irinotecan, leucovorin, and 5‐fluorouracil) demonstrated a statistically significant improvement in 1-year overall survival (OS) with minimal toxicity. These trial findings suggest a potential benefit of adding OSE2101 to maintenance chemotherapy.

References

https://www.clinicaltrials.gov/study/NCT03806309

https://ascopubs.org/doi/10.1200/JCO.2025.43.16_suppl.4009

Author:

Ana Martins