ESMO Reaction
September 15, 2022

ESMO Reactions: COSMIC-313

ESMO Reaction
September 15, 2022

ESMO Reactions: COSMIC-313


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


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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