Few baseline characteristics may be helpful for identifying long-term survivors among patients with advanced renal cell carcinoma (aRCC) who receive first-line nivolumab plus ipilimumab (nivo-ipi), according to research presented at the International Kidney Cancer Symposium (IKCS) 2021.
“Baseline demographics and clinical characteristics generally did not distinguish patients with long-term survival in the nivo-ipi arm from the overall population of nivo-ipi patients,” said Nizar M. Tannir, MD, of MD Anderson Cancer Center in Houston, who presented this research at the meeting.
However, Dr Tannir and colleagues did find that patients with smaller target lesions at baseline were more likely to be long-term survivors. Conversely, patients with poor-risk disease or bone metastases were less likely to survive long term.
The researchers uncovered these findings via a post hoc analysis of the phase 3 CheckMate 214 study (ClinicalTrials.gov Identifier: NCT02231749). The trial was designed to compare nivo-ipi with sunitinib monotherapy in patients with aRCC. For the post hoc analysis, researchers evaluated long-term survivors, defined as patients who survived 5 years or more.
The study included 1096 patients who were randomly assigned to receive nivo-ipi (n=550) or sunitinib (n=546). The proportion of long-term survivors was 43% (n=236) in the nivo-ipi arm and 31% (n=171) in the sunitinib arm.
Long-term survivors in the nivo-ipi arm were more likely to have smaller target legions at baseline than the overall nivo-ipi population, with a median size of 50.5 mm and 65.5 mm, respectively.
Long-term survivors in the nivo-ipi arm were less likely than the overall nivo-ipi population to have bone metastases — 11% and 20%, respectively — or poor-risk disease — 11% and 17%, respectively.
Dr Tannir noted that there was a greater likelihood of long-term clinical benefit with nivo-ipi vs sunitinib in patients who had intermediate/poor-risk disease at baseline, which was not surprising. The surprise, he said, was that the same pattern was observed in patients with favorable-risk disease at baseline.
Among all long-term survivors, the median duration of response (DOR) was not reached in the nivo-ipi arm and was 38.7 months in the sunitinib arm. The median DOR was not reached for nivo-ipi recipients regardless of risk group. Among sunitinib recipients, the median DOR was 23.5 months for patients with intermediate/poor-risk disease and 51.4 months for those with favorable-risk disease.
Dr Tannir pointed out, however, that a lack of response did not prevent some patients from being long-term survivors. In fact, 39% of long-term survivors assigned to nivo-ipi and 44% of those assigned to sunitinib did not respond to study treatment.
Similarly, experiencing treatment-related adverse events leading to discontinuation did not prevent patients from becoming long-term survivors. Such events occurred in 28% of long-term survivors in the nivo-ipi arm and 16% of those in the sunitinib arm.
Roughly half (48%) of long-term survivors in the nivo-ipi arm received subsequent therapy, compared with 78% of those in the sunitinib arm.
Disclosures: This study was supported by Bristol Myers Squibb and Ono Pharmaceutical Co. Ltd. Dr Tannir disclosed affiliations with Bristol Myers Squibb, Pfizer, Nektar Therapeutics, Exelixis, Eisai, Eli Lilly, Oncorena, Calithera Biosciences, Surface Oncology, Novartis, Ipsen, Merck, Arrowhead, Mirati, and Takeda.
Tannir NM, Motzer RJ, McDermott DF, et al. First-line nivolumab plus ipilimumab (NIVO+IPI) versus sunitinib (SUN) in patients with long- term survival of ≥5 years in the CheckMate 214 trial. Presented at: IKCS 2021; November 5-6, 2021. Abstract CTR11.
This article originally appeared on Cancer Therapy Advisor