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Efficacy and Safety of Ibrutinib Combined with Standard First-Line Treatment or As Substitute for AutologousStem Cell Transplantation in Younger Patients with Mantle Cell Lymphoma: Results from the Randomized Triangle Trial By the European MCL Network

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Abstract #1: Martin Dreyling presented efficacy and safety results of the P3 TRIANGLE trial in 870 younger patients with previously untreated, advanced stage II-IV mantle cell lymphoma(MCL).

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The TRIANGLE trial assessed:

Standard treatment (R-CHOP/R-DHAP + ASCT) (Arm A);
vs addition of ibrutinib to Arm A regimen (Arm A+I);
vs standard treatment with ibrutinib but without ASCT (Arm I);
followed by 2 years ibrutinib maintenance in arms A+I and I

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Results:

Overall response (OR) rates: 94% (arm A) vs 98% (combined arms A+I/I)
Complete remission (CR) rates: 36% (arm A) vs 45% (combined arms A+I/I)
3-year failure-free survival (FFS): 86% (arm I) vs 88% (arm A+I) vs 72% (arm A)
3-year OS: 92% (arm I) vs 91% (arm A+I) vs 86% (arm A)
Rituximab maintenance did not substantively change results
No substantial differences in grade 3-5 AEs when adding ibrutinib to standard treatment or between the two ASCT-containing arms
Substantially more grade 3-5 AEs in A+I arm as compared to arms A or I during maintenance

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Thought leader reactions were positive, with several interpreting the results to mean that they could forego ASCT during induction with ibrutinib without compromising on OS and FFS, and thus considering it as new standard first-line therapy for younger patients with MCL.

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The favourable AE profile and lack of treatment related mortality (TRM) with ibrutinib induction without ASCT was also of interest.

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A few oncologists were concerned about the cost of ibrutinib maintenance in lower and middle income countries (LMIC)

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Summary: Thought leaders are excited enough by these results that many consider induction with ibrutinib without ASCT to be a new first-line treatment younger patients with previously untreated, advanced stage II-IV MCL. More study will need to be done to confirm the role of ASCT in this population, and in localities where ibrutinib might be costly to use.

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Not rated

Allison Betof Warner, MD, PhD (she/her) 4

@DrBetofMDPhD

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

@DrBetofMDPhD

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

@alexshoushtari

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

@DrBetofMDPhD

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

@HTawbi_MD

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

DrBetofMDPhD

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

@montypal

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

@Shilpaonc

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

@TiansterZhang

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

@MosheOrnsteinMD

1930 Followers

Cleveland, OH

November 8, 2022

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

Not Rated

Shuchi Gulati MD

@ShuchiGulati

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

@PGrivasMDPhD

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 @PauloBergerot t.co/RNzOwxixQm

ASH22 Reaction - TRIANGLE

ASH22 Reaction - TRIANGLE

Efficacy and Safety of Ibrutinib Combined with Standard First-Line Treatment or As Substitute for AutologousStem Cell Transplantation in Younger Patients with Mantle Cell Lymphoma: Results from the Randomized Triangle Trial By the European MCL Network

Abstract #1: Martin Dreyling presented efficacy and safety results of the P3 TRIANGLE trial in 870 younger patients with previously untreated, advanced stage II-IV mantle cell lymphoma(MCL).

The TRIANGLE trial assessed:

Results:

Thought leader reactions were positive, with several interpreting the results to mean that they could forego ASCT during induction with ibrutinib without compromising on OS and FFS, and thus considering it as new standard first-line therapy for younger patients with MCL.

‍

The favourable AE profile and lack of treatment related mortality (TRM) with ibrutinib induction without ASCT was also of interest.

A few oncologists were concerned about the cost of ibrutinib maintenance in lower and middle income countries (LMIC)

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