SABCS Reactions - MonarchE

December 9, 2022

SABCS Reactions - MonarchE

Author

Abemaciclib plus endocrine therapy for HR+, HER2-, node-positive, high-risk early breast cancer: results from a pre-planned monarchE overall survival interim analysis, including 4-year efficacy outcomes

Abstract #GS1-09: Prof. Stephen Johnston presented interim OS data from the P3 monarchE trial, assessing abemaciclib plus endocrine therapy (ET) in 5,637 patients with HR+, HER2-, node-positive, high-risk early breast cancer.

Results:

  • Abemaciclib demonstrated sustained benefit even after discontinuation – invasive disease-free survival (IDFS) 4-year rates were better than 2- and 3-year
  • At 4 years, rates of IDFS in the abemaciclib + ET arm were 85.8% vs 79.4% in the ET only arm
  • Rates of distant relapse-free survival (DRFS)were 88.4% in the abema + ET arm vs 82.8% in the ET alone arm
  • OS remains immature; but fewer deaths occurred in the abema + ET arm vs the ET alone arm (5.6% vs 6.1%)
  • No new safety signals observed
  • While many thought leaders find the IDFS and DRFS benefit and reduced recurrence risk encouraging . . .

    . . . they await mature OS data and claim that practice is unlikely to change until demonstrable OS benefit is shown.

    Managing abemaciclib side effects will be increasingly important given lasting efficacy.

    Summary:

    Though abemaciclib plus endocrine therapy (ET) provides sustained benefit in HR+, HER2-, node-positive, high-risk early breast cancer, the combination is unlikely to be practice changing until it demonstrates improved OS.

    Synthesis by Opus Strategy, LLC

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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?

    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
    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

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