ASCO GI Reaction
January 22, 2023

ASCO GI Reaction - Neo AEGIS

ASCO GI Reaction
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%

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.

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.

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

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

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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Not rated
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.

Not rated
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

Positive
Alex Shoushtari, MD
2253
New York, USA
November 10, 2022

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.

Not rated
Allison Betof Warner, MD, PhD (she/her) 2
3743
Manhattan, NY
November 10, 2022

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

Positive
Hussein Tawbi, MD, PhD
1685
Houston, TX
November 10, 2022

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

Positive
Allison Betof Warner, MD, PhD (she/her) 1
3744
Manhattan, NY
November 10, 2022

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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Sumanta K. Pal, MD, FASCO
15083 Followers
Los Angeles, CA
November 8, 2022

Just before I start AM clinic at @cityofhopeoc, excited to share results from #COBALT_RCC, a P1 trial of @CRISPRTX#CTX130 in #kidneycancer in the @sitcancer#PressProgram. Will present more on Thurs 5:37p at #SITC22! Thx @neerajaiims@DrBenTran@HaanenJohn#SamerSrour& co-Is! t.co/aDnhG9n92A

not rated
Shilpa Gupta
5095 Followers
Cleveland, OH
November 8, 2022
Not Rated
Tian Zhang, MD, MHS
6463 Followers
Dallas, TX
November 8, 2022

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

Not Rated
Moshe Ornstein MD
1930 Followers
Cleveland, OH
November 8, 2022

Congrats @montypal and team! Great to see CAR T therapy coming to #RCCt.co/ypRHBC89Pt

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Shuchi Gulati MD
12476 Followers
Seattle, WA
November 8, 2022

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

Not Rated
Petros Grivas
12476 Followers
Seattle, WA
November 8, 2022

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