Dr. Aly-Khan Lalani, MD gives an overview of the advancements in Kidney Cancer presented at ESMO 2017 including the Cabosun and Checkmate 214 trial results.
The Alliance for Clinical Trials in Oncology as part of Exelixis
collaboration with the National Cancer Institutes Cancer Therapy Evaluation Program (NCI-CTEP). The
data presented at ESMO 2017 included the analysis from a blinded independent radiology review
committee (IRC), which confirmed the primary efficacy endpoint results of investigator-assessed
progression-free survival (PFS), as well as an updated investigator-assessed analysis. Per the IRC
analysis, cabozantinib demonstrated a clinically meaningful and statistically significant 52 percent
reduction in the rate of disease progression or death (HR 0.48, 95% CI 0.31-0.74, two-sided P=0.0008).
The median PFS for cabozantinib was 8.6 months versus 5.3 months for sunitinib, corresponding to a
3.3 month (62 percent) improvement favoring cabozantinib over sunitinib.
CHECKMATE 214 Conclusions:
According to the investigators, findings from this phase III trial support the use of combined nivolumab plus ipilimumab as a potential first-line treatment for patients with intermediate/poor risk metastatic RCC, particularly those patients having tumour PD-L1 expression ?1%. However, it does not support its use in good risk patients.
Trying to address if superiority of nivolumab plus ipilimumab over sunitinib is a paradigm change in mRCC first-line treatment, Manuela Schmidinger of the Medical University of Vienna, Austria said to some extent yes as sunitinib has never been defeated before. For her it was so brave to choose it as a comparator. Nivolumab plus ipilimumab induces a high rate of objective responses. The quality of the response is highlighted by the rate of complete remissions, the duration of response and its translation into OS benefit. Checkpoint inhibitor first-line treatment is a new standard of care (with massive impact), however there is not the final picture yet. Once we will be able to properly address the biology of a patients individual tumour, we may pick out the best individual treatment among various first-line options. Furthermore, multiple combinations are currently under investigation in phase III trials, some of these combinations will most likely be included in the standard of care. The current data are also encouraging news for those who conduct phase III trials with immuno-oncology-VEGF-inhibitor combinations vs sunitinib.