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January 22, 2023

ASCO GI Reaction - INFINITY

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January 22, 2023

ASCO GI Reaction - INFINITY

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INFINITY: A multicentre, single-arm, multi-cohort, phase II trial of tremelimumab and durvalumab as neoadjuvant treatment of patients with microsatellite instability-high (MSI) resectable gastric or gastroesophageal junction adenocarcinoma (GAC/GEJAC)

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Abstract #358: Filippo Pietrantonio presented results of Cohort 1 (n=18) of the P2 INFINITY trial assessing tremelimumab + durvalumab as neoadjuvant treatment for MSI, mismatch repair deficient (dMMR) and EBV-negative resectable GAC/GEJAC.

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Results:

  • Among 15 evaluable pts, 14 underwent resection, and 1 had disease progression
  • pCR rate: 60%
    • All pts with pCR had negative ctDNA status pre-surgery
    • pCR rate was 17% in T4 vs 89% in T2-3 tumors
  • Rate of major complete pathological response (<10% viable cells): 80%
  •  Immune-related grade ≥3AEs: hepatitis, colitis, and pneumonitis (1% each); all resolved with steroids and did not impair surgery
  • No grade 5 toxicities; 2 pts died post-surgery, not related to disease or AEs

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ASCOGI

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Thought leader reactions were positive, with many lauding the excellent response to neoadjuvant immunotherapy with tremelimumab + durvalumab and considering it curative for MSI, dMMR and EBV-negative resectable GAC/GEJAC. Several oncologists praised the success of the primary endpoint (60% pCR rate), with many calling the resultant waterfall plot a “Chalabi plot” in reference to recent ground-breaking work done by Myriam Chalabi in colon cancer

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Yakup
Dario
Arndt
Myriam
Pashtoon
Tim Brown

However, several commentators stressed that larger trials are required to confirm both the efficacy results of and the extent of IO toxicities

‍

Mustapha
Amol
Joseph

Thought leaders also felt that, though the results are promising for T1/T2 patents, T4 patients need different options – a sentiment possibly supported by the amendment of the trial to exclude T4 patients.

‍

Anita
Hagen

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Summary:

‍Thought leaders praised the possibly curative response to neoadjuvant immunotherapy with tremelimumab+ durvalumab seen in patients with MSI, dMMR, and EBV-negative resectable GAC/GEJAC. However, larger trials are required to confirm the efficacy and safety of this combination. In addition, efficacy for more advanced tumors (T4) has not been established.

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Expert synthesis provided by Opus Strategy LLC

Opus

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Download attached file
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?

Not Rated
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

@montypal@cityofhopeoc@CRISPRTX@sitcancer@neerajaiims@DrBenTran@HaanenJohn@DrChoueiri@TiansterZhang@tompowles1@brian_rini@AlbigesL@Uromigos@ERPlimackMD@drenriquegrande@PGrivasMDPhD Congrats Monty! Looking forward to hearing about this exciting first-in the field study!

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

Not Rated
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

@montypal you never stop to amaze me! You are brilliant & awesome! Looking forward to hearing more about this trial @sitcancer@OncoAlert@CityofHope_GU@COHMDCareers@neerajaiims@KidneyCancer@KidneyCancerDoc@NazliDizman@ZeynepZengin@LuisMezaco@crisbergerot@PauloBergerott.co/RNzOwxixQm

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