ESMO 2026 | ENERGIZE: neoadjuvant chemotherapy with or without nivolumab in MIBC

Yeah, we presented the final results of what is known to most of the oncologists as the ENERGIZE trial, a trial randomizing patients to receive NIVO-GEMCIS and NIVO-adjuvantly versus GEMSYS and radical cystectomy alone in patients with MIBC clinical T2-4, N0, M0 stage with predominant urothelial histology. It was a classical perioperative trial design, randomizing patients with the perioperative therapy versus the classical neoadjuvant therapy. We are here dealing with the patients who are cisplatin eligible. So the primary endpoint, the co-primary endpoint for the trial were pathological complete response rate and EFS, event-free survival, as a centralized assessment. The trial initially included the third arm with the IDO-1 inhibitor in combination with GEMCYS and NIVO with matched placebo, but the arm was terminated early in December 2021 due to IDMC decision recommendation. The main findings of the trial are related to the pathological complete response rate. There was a 39% for NIVO-GEMC with an absolute improvement as compared to GEMCYS of 9.5%. But despite this difference, the trial did not meet the pre-specified threshold of significance for PCR. EFS, the same, was not significant. The hazard ratio for EFS was 0.94. The median EFS was not reached with NIVO GEMSYS. It was 67 months for GEMSYS alone. So, even in this case, the trial was negative. Overall survival was presented just descriptively because of the fact that the EFS was negative and the Kaplan-Meier curves were actually superimposing with the median overall survival that was not reached in either arm. Safety was pretty much in line with what was expected with the use of checkpoint inhibitor and chemotherapy, so nothing in particular that emerged from the safety standpoint. And we just presented the outcomes from the exploratory endpoint of CT-DNA, the Signatera personalized CT-DNA assay that was evaluated on day one at baseline and post neoadjuvant therapy corroborating the robustness of the prognostic value of ctDNA in the combined biomarker population by combining the two arms patients who were positive at baseline had a very much inferior EFS as compared to those who were negative and remain negative or those who were positive and got the clearance of the ctDNA so these results overall suggest that from the biomarker standpoint ctDNA is a useful prognostic indicator in this patient population also in the neoadjuvant setting not just in the adjuvant setting and the NIVO-GEMC immunotherapy chemotherapy combination could be practiced for me in the adjuvant setting and the NIVO-GEMC’s immunotherapy chemotherapy combination could be practiced for me in the way we will tomorrow conceive still the use of cisplatin chemotherapy in this patient population.

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