January 23, 2023

ASCO GI Reaction - Neo AEGIS

January 23, 2023

ASCO GI Reaction - Neo AEGIS

Author

Neo-AEGIS (Neoadjuvant Trial inAdenocarcinoma of the Esophagus and Esophago-Gastric Junction InternationalStudy): Final primary outcome analysis.

Abstract #295: Maeve Aine Lowery presented the primary outcome analysis of the P3 Neo-AEGIS trial in 362 evaluable pts with locally advanced adenocarcinoma of the esophagus and esophago-gastric junction (AEG). The trial compared the multimodal CROSS (carboplatin/paclitaxel, 41.4 Gyradiation therapy) (n=178) regimen with peri-operative chemotherapies – a modified MAGIC (epirubicin, cisplatin (oxaliplatin), 5-FU (capecitabine))(n=157) regimen (ECF/ECX/EOF/EOX pre-2018) or FLOT (docetaxel, 5-FU,leucovorin, oxaliplatin in 2019/2020) (n=27) regimen

Results:

  • CROSS vs MAGIC/FLOT arms:
    • 3-year estimated survival probability: 57% vs 55%
    • Major pathological response: 42% vs 12.1%
    • pCR: 17.3% vs 5.1%
    • Deaths: 91 vs 95 at median 34.2 months
    • Toxicity/AEs
      • Toxic deaths: 3% vs. 1.6%
      • Neutropenia: 2.8% vs. 14.1%
      • Diarrhea: 0% vs. 10.9%
      • Neutropenic sepsis: 0.6% vs. 2.2%
      • Vomiting: 2.8% vs. 7.6%
      • Pulmonary embolism: 5.1% vs. 5.4%

Neo-Aegis

Thought leaders agreed with the investigators that the trial results were not clarifying; many were left unsure as to which option was preferable between preop CROSS chemoradiation and periop MAGIC/FLOT chemo.

Antony
Grant
Tim Brown

Many commentators found the results unhelpful given that relatively few patients received FLOT perioperative chemo, and that therefore CROSS and FLOT had not had a true head-to-head comparison.

ILSON
Santhosh
Joao
Namrata

Amol

Some oncologists expressed surprise that the significant response rate associated with CROSS did not translate into a major survival benefit.

Yakup
Flavio
Monique

Several oncologists wanted to see the impact of adjuvant immunotherapy in patients with a response.

Dr Joseph
Mike
Mustapha
Thierry

Summary:

Thought leaders agreed that the results presented in the Neo-AEGIS trial did not definitively favor either preop CROSS chemoradiation or periop MAGIC/FLOT chemo in locally advanced adenocarcinoma of the esophagus and esophago-gastric junction (AEG). There was particular disappointment that FLOT, considered the superior periop chemo regimen, was not adequately tested against CROSS.

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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
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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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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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