January 23, 2023

ASCO GI Reaction - NAPOLI-3

January 23, 2023

ASCO GI Reaction - NAPOLI-3

Author

NAPOLI-3: A randomized, open-label phase 3 study of liposomal irinotecan + 5-fluorouracil/leucovorin + oxaliplatin(NALIRIFOX) versus nab-paclitaxel + gemcitabine in treatment-naïve patients with metastatic pancreatic ductal adenocarcinoma (mPDAC)

Abstract #LBA661: Zev A. Wainberg presented results of the P3 NAPOLI-3 trial comparing liposomal irinotecan + 5-fluorouracil/leucovorin + oxaliplatin (NALIRIFOX) vsnab-paclitaxel + gemcitabine (Gem+NabP) in 770 treatment-naïve pts with mPDAC

Results:

  • NALIFIROX vs. Gem+NabP:
    • Median OS: 11.1 vs. 9.2 months
    • Median PFS: 7.4 vs 5.6 months
    • Grade 3/4 TEAEs:
      • Diarrhea (20.3% vs 4.5%)
      • Nausea (11.9% vs 2.6%)
      • Hypokalemia (15.1% vs 4.0%)
      • Anemia (10.5% vs 17.4%)
      • Neutropenia (14.1% vs 24.5%)

Napoli

Thought leader reactions were mixed. Some were excited that the trial met its primary endpoint of improved survival in treatment-naïve mPDAC.

Tim
Syed
Noelle
ilson

A few oncologists declared NALIRIFOX “a” new standard of care – but not “the” new standard of care in this patient population.

Uqba
Laura

Many commentators viewed NALIRIFOX as superior to Gem+NabP but not to FOLFIRINOX –and felt that the results did not represent an advance for pancreatic cancer.

Mark
Bishal
Benjamin

Several raised concerns around cost and access to liposomal irinotecan – and believed that NALIRIFOX would not be cost-effective compared to FOLFIRINOX.

bijoy
Ravi R
KMody
Rachel

Others bemoaned the lack of QoL data and felt that QoL was more important than survival for a terminal disease, particularly for older patients.

Ramy
Michael
Bishal

Summary:

While NAPOLI-3 met its primary endpoint of improved survival in treatment-naïve mPDAC, and could present another option for patients, thought leaders remain skeptical of NALIRIFOX as the new standard of care in this population. NALIRIFOX will likely be considerably more expensive than FOLFIRINOX (FFX) and confers a similar survival benefit, leaving many to wonder why they would choose this new regimen over FFX. Some oncologists also felt that the lack of quality-of-life data represented a significant gap in the case for NALIRIFOX.

 

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3743
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79% had reduction in disease. ORR 31%. Many responses deepen over time.

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Toxicity profile was in line with prior TIL/Lifileucel data. No surprises here. Median # doses of IL-2 was 6.

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Absolutely agree!… this should be available to our melanoma patients ASAP!… and paves the way for smarter cellular therapies to be designed, studied, and eventually widely disseminated

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