Andrea Boutros: RELATIVITY-047 trial showing sustained benefit of Nivolumab plus Ipilimumab in advanced melanoma
Andrea Boutros, Medical Doctor and Oncology Resident at San Martino Polyclinic Hospital, shared on X:
“Just published: 3-year OS data from RELATIVITY-047 trial showing sustained benefit of nivo+rela in advanced melanoma. Let’s analyze how this combination compares to the established ipi+nivo standard.
Key context: Until now, ipi+nivo has been our benchmark with impressive 10 years MSS of 52% in CM-067. But toxicity profile (G3/4 AEs ~59%) has always been challenging.
New RELATIVITY-047 data shows:
– mOS: 51.0 months
– 36-month OS rate: 55%
– G3/4 AEs: 22% Strong efficacy signals with notably lower toxicity vs historical ipi+nivo data
Looking at effectiveness:
PFS: 10 months with nivo+rela
ORR: 44% Remarkably similar to ipi+nivo’s historical performance, particularly in PD-L1 low expressors
Interesting regulatory split: While FDA approved nivo+rela for all comers, EMA restricted approval to PD-L1<1% patients based on stronger benefit in this subgroup…
Critical analysis of ROC curves from RELATIVITY-047 (Fig A3 Suppl.) shows PD-L1 is a poor predictive biomarker:
AUC for PFS: 0.57
AUC for OS: 0.51
AUC for ORR: 0.57
Let’s look at HR for OS by PD-L1 status:
PD-L1 <1%: HR 0.83 (0.58-1.18)
PD-L1 ≥1%: HR 0.78 (0.61-1.01)
Very similar benefit across subgroups!
Poll: Do you agree with EMA’s decision to restrict nivo+rela to PD-L1<1%?
Options:
– Data support broader use
– Need more biomarker data
– Costs matter
Important caveat: No direct head-to-head comparison yet. Cross-trial comparisons have inherent limitations
Activity and safety of first-line treatments for advanced melanoma: A network meta-analysis
Authors: Andrea Boutros, Enrica Teresa Tanda, Elena Croce, Fabio Catalano, Marcello Ceppi, Marco Bruzzone, Federica Cecchi, Luca Arecco, Matteo Fraguglia, Paolo Pronzato, Carlo Genova, Lucia Del Mastro, Matteo Lambertini, Francesco Spagnolo
Important knowledge gap: Limited data on nivo+rela in special populations
Key point: No data available for active brain mets in RELATIVITY-047 (excluded by protocol)
1.7% vs 3.1% had stable brain mets only
In contrast, robust ipi+nivo data from CheckMate204 & ABC trials
Poll 2: Are ipilimumab+nivolumab and nivolumab+relatlimab equivalent therapeutic options in advanced melanoma?
Options:
– Same efficacy, less tox
– Same with few exceptions
– Need more long term data
Conclusion: Nivo+rela emerges as a potentially equivalent option to ipi+nivo with better tolerability. Could become preferred choice for select patients, but mature OS data still needed.”
Final, 10-Year Outcomes with Nivolumab plus Ipilimumab in Advanced Melanoma
Authors: Jedd D. Wolchok, Vanna Chiarion-Sileni, Piotr Rutkowski, C. Lance Cowey, Dirk Schadendorf, John Wagstaff, Paola Queirolo, Reinhard Dummer, Marcus O. Butler, Andrew G. Hill, Michael A. Postow, Caroline Gaudy-Marqueste, Theresa Medina, Christopher D. Lao, John Walker, Iván Márquez-Rodas, John B.A.G. Haanen, Massimo Guidoboni, Michele Maio, Patrick Schöffski, Matteo S. Carlino, Shahneen Sandhu, Céleste Lebbé, Paolo A. Ascierto, Georgina V. Long, Corey Ritchings, Ayman Nassar, Margarita Askelson, Melanie Pe Benito, Wenjia Wang, F. Stephen Hodi, James Larkin, for the CheckMate 067 Investigators
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