Enrique Grande, One Oncology Madrid Program Director of Quirónsalud, Adjunct Professor at The University of Texas MD Anderson Cancer Center, shared on LinkedIn:
“Adjuvant durvalumab in RCC: what RAMPART tells us about the limits of immunotherapy
Not every trial changes practice by showing benefit.
Some change it by defining limits.
RAMPART — the phase 3 trial evaluating adjuvant durvalumab, with or without tremelimumab, versus active monitoring after resection of RCC — did not demonstrate a significant improvement in disease-free survival with durvalumab monotherapy versus observation.
This is an important result. And it deserves more than a footnote.
A few things worth reflecting on:
- The adjuvant RCC landscape is not uniform. Pembrolizumab improved disease-free survival in KEYNOTE-564. Now the combination of pembrolizumab plus belzutifan has shown further benefit in LITESPARK-022. But durvalumab alone does not appear to add to observation in this setting. Why the difference? PD-1 versus PD-L1 inhibition, patient selection, trial design – these are questions worth asking carefully.
- Negative trials are not failed science. RAMPART was rigorously designed and executed. The fact that it did not show benefit is itself clinically meaningful — it tells us that not all checkpoint inhibitors are interchangeable in the adjuvant setting.
- Patient selection remains the central challenge. Who truly benefits from adjuvant IO in RCC? The answer is still not fully defined. ctDNA, molecular profiling and risk stratification tools are evolving — but we are not yet at the point where we can reliably identify the patients most likely to benefit from any given agent.
- Active monitoring is a valid strategy. RAMPART reinforces something important: in the absence of proven benefit, doing less is not the same as doing nothing. Observation with structured follow-up is a legitimate clinical choice — and one that avoids unnecessary toxicity.
The adjuvant RCC space is maturing.
And with maturity comes the ability to distinguish between agents, not just between treatment and no treatment.”
Read also “OMNIVORE Long-Term Follow-Up: Durable Treatment-Free Survival After Early Response to Nivolumab in Advanced RCC” on Oncodaily.
