ESMO Reaction
September 15, 2022

ESMO Reactions: COSMIC-313

ESMO Reaction
September 15, 2022

ESMO Reactions: COSMIC-313

Author

Phase III study ofcabozantinib (C) in combination with nivolumab (N) and ipilimumab (I) inpreviously untreated advanced renal cell carcinoma (aRCC) of IMDC intermediateor poor risk (COSMIC-313)

Abstract #LB8A: Toni Choueiri presented the primary analysis of the P3 COSMIC-313 trial. The trial compared cabozantinib + nivolumab +ipilimumab (C+N+I) (n=428) versus placebo (P)+N+I (n=427) in previously untreated patients with clear cell aRCC of IMDC intermediate (75%) or poor risk (25%).

Results: Met primary PFS endpoint; median PFS not yet reached in this ongoing trial for C+N+I vs 11.3 months for P+N+I. ORR was43% for C+N+I vs 36% for P+N+I; Grade 3/4 TRAEs occurred in 73% of pts with C+N+I vs 41% with P+N+I; TRAEs led to discontinuation in12% vs 5%. OS data analysis ongoing.

Thought leaders consider this ongoing trial important as it is the first P3 RCC trial with triplet vs. modern IO doublet in RCC and is showing PFS benefit.

However, many feel that OS data would be required before changing standard of care

Many oncologists express concerns around toxicity, discontinuations and cost with triplet therapy

Some oncologists feel that sequencing the agents might yield better results than concomitant use

Commentators also wonder which patient group is likely to benefit most from triplet therapy

Summary:

COSMIC-313 is the first trial showing PFS benefit of triplet therapy (cabozantinib+ nivolumab + ipilimumab) vs modern IO doublet in intermediate risk aRCC.However, oncologists are concerned about toxicity, treatment discontinuations, and cost. OS data will be necessary to fully assess the use and benefit of triplet therapy in this population; subgroup analysis could also help indicate patients who would benefit the most.

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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