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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
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
79% had reduction in disease. ORR 31%. Many responses deepen over time.
Toxicity profile was in line with prior TIL/Lifileucel data. No surprises here. Median # doses of IL-2 was 6.
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
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
@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!
CAR-Ts are coming for #kidneycancer!! Congratulations @montypal and team; can’t wait to see results at #SITC22! t.co/9MrlF2yzBe
Congrats @montypal and team! Great to see CAR T therapy coming to #RCCt.co/ypRHBC89Pt
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
@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
