ASCO GI Reaction
January 22, 2023

ASCO GI Reaction - NAPOLI-3

ASCO GI Reaction
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%)

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

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

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.

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

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

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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Allison Betof Warner, MD, PhD (she/her) 4
3743
Manhattan, NY
November 10, 2022

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

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Allison Betof Warner, MD, PhD (she/her) 3
3743
Manhattan, NY
November 10, 2022

Median DOR not yet reached. Median OS 13.9 mo. 12 mo OS was 54%. As typical with immunotherapy, we see a nice tail on the curve. #TIL#SITC22

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Important work on efficacy of TIL therapy lifileucel in PD-1 resistant #melanoma being presented at #SITC22. Pretty good durability for this heavy lift of a treatment.

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Allison Betof Warner, MD, PhD (she/her) 2
3743
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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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Where does this leave us with #TIL therapy for #melanoma? IMO, this response rate/durability justifies accelerated approval. Pts with PD-1 refractory melanoma need options. It’s FAR from a perfect tx but provides meaningful clinical benefit. What say you melanoma Twitterverse?

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CAR-Ts are coming for #kidneycancer!! Congratulations @montypal and team; can’t wait to see results at #SITC22! t.co/9MrlF2yzBe

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Another huge step from none other than @montypal!! CAR-Ts in #kidneycancer!Congratulations to the entire team!Looking forward to seeing the results at #SITC22! t.co/HvKeVBPyV7

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