ASH 22 Reactions
December 13, 2022

ASH 22 Reactions - GEM-CESAR

ASH 22 Reactions
December 13, 2022

ASH 22 Reactions - GEM-CESAR

Author

Abstract # 118: María Victoria Mateos presented post-hoc analysis from the P2 GEM-CESAR trial in 90 patients with high-risk smoldering myeloma (SMM).GEM-CESAR assessed induction and consolidation chemotherapy with carfilzomib, lenalidomide and dexamethasone before and after melphalan and autologous stem cell transplant (ASCT), respectively, followed by lenalidomide and dexamethasone maintenance.

Results:

  • At median 65.8 mos, 94% of pts were alive and progression-free: 6 pts progressed to MM and 7 pts died
  • In same time frame, 31 patients had progressed to measurable residual disease; PFS at 5 years was 72%
  • Of the seven patient deaths:
    • Three progressive disease related
    • 1 cardiac arrest (not treatment-related)
    • 1 ischemic stroke
    • 1 lung cancer
    • 1 MDS
  • Sustained negative measurable residual disease 23% at 4 years post-ASCT

Thought leader reactions were largely negative, with several strongly condemning the death of asymptomatic patients in this trial:

Carfilzomib, lenalidomide and dexamethasone (KRd) protocol with ASCT was not considered to be the most efficacious treatment for asymptomatic SMM:

One thought leader raised concerns regarding a misdiagnosed patient population, and significant AEs:

Summary: Some thought leaders were critical of the GEM-CESAR trial, as asymptomatic patients suffered AEs(including deaths) for minimal benefit. While some commentators found the data more useful than others, theconsensus was that the carfilzomib, lenalidomide and dexamethasone protocol with ASCT is not to be used in asymptomatic patients with high-risk smoldering myeloma.

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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
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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
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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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