Real world outcomes of first line (1L) nivolumab and ipilimumab (NIVO IPI) in metastatic renal cell carcinoma (mRCC): An update from the International mRCC Database Consortium (IMDC).

Authors

null

Connor Wells

Barts Cancer Institute, London, United Kingdom

Connor Wells , Evan Ferrier , Audreylie Lemelin , Thomas Powles , Sumanta Kumar Pal , Hedyeh Ebrahimi , Neeraj Agarwal , Benoit Beuselinck , Georg A. Bjarnason , Lori Wood , Christina M. Canil , Renee Maria Saliby , Guillermo de Velasco , Rana R. McKay , Ben Tran , Cristina Suárez , Arnoud J. Templeton , Toni K. Choueiri , Daniel Yick Chin Heng

Organizations

Barts Cancer Institute, London, United Kingdom, Tom Baker Cancer Centre, Calgary, AB, Canada, Barts Cancer Institute, Cancer Research UK Experimental Cancer Medicine Centre, Queen Mary University of London, London, United Kingdom, City of Hope Comprehensive Cancer Center, Duarte, CA, Huntsman Cancer Institute at the University of Utah, Salt Lake City, UT, UZ Gasthuisberg - Katholieke University Leuven, Leuven, Belgium, Sunnybrook Odette Cancer Centre, Toronto, ON, Canada, Queen Elizabeth II Health Sciences Centre, Dalhousie University, Halifax, NS, Canada, The Ottawa Hospital Cancer Centre, Ottawa, ON, Canada, Dana-Farber Cancer Institute, Boston, MA, Medical Oncology Department, Hospital Universitario 12 de Octubre, Madrid, Spain, University of California, San Diego, La Jolla, CA, Peter MacCallum Cancer Centre, Melbourne, VIC, Australia, Medical Oncology, Vall d'Hebron University Hospital, Barcelona, Spain, St. Claraspital, Basel, Switzerland, The Lank Center for Genitourinary Oncology, Dana-Farber Cancer Institute, Boston, MA, Tom Baker Cancer Centre, University of Calgary, Calgary, AB, Canada

Research Funding

No funding sources reported

Background: NIVO IPI is one of several 1L treatment options for mRCC and is limited to intermediate and poor risk disease in many jurisdictions. We report the outcomes of 1L NIVO IPI from the IMDC. Methods: All IMDC patients who received 1L NIVO IPI were retrospectively analyzed. Key outcomes were compared between IMDC risk groups and included overall survival (OS), time to treatment discontinuation (TTD), time to next treatment (TTNT; defined as time from 1L initiation to next treatment) and response rates. Conditional OS by 6- and 12-month survival are described. Results: 1145 patients received 1L NIVO IPI, including 94 favourable, 559 intermediate, and 313 poor risk patients. 818/980 (86%) of patients had clear cell histology and 14% had sarcomatoid features. The median follow up was 20.0 months. 837/1145 (73%) patients had stopped 1L NIVO IPI and 363/1145 (32%) were deceased. Key outcomes of interest are summarized in Table 1. Subsequent 2L therapy was received by 438/727 (60%) patients and was most frequently sunitinib (37%) and cabozantinib (28%). 3L therapy was received by 160/477 (34%) patients, most often cabozantinib (29%). Immune related adverse events were documented in 48% (274/572) of patients. Conditional survival analysis showed that if a patient was alive at 6 months after starting 1L NIVO IPI, they had an 81% likelihood of being alive for an additional year and a 68% likelihood of surviving two years. If alive at 12 months, there was an 81% chance of surviving one additional year and 68% chance of surviving two additional years. If a patient remained on 1L NIVO IPI for 6 months, there was a 91% likelihood of being alive for one additional year and 76% likelihood of being alive for two years. If they remained on NIVO IPI for 12 months, there was a 94% chance of being alive for one additional year and an 84% chance of surviving two additional years. Conclusions: This large cohort of real-world patients provides benchmark data for clinical trial design and patient counselling, with a median OS surpassing 50 months for intermediate risk patients.

Outcomes of interest by IMDC risk group.

IMDC Favourable Risk (n=94)*IMDC Intermediate Risk (n=559)IMDC Poor Risk (n=313)P-value
OS (months; 95%CI)47.8 (40.8-93.0)51.1 (44.4-NR)18.3 (13.9-26.3)<0.001
TTD (months; 95%CI)6.5 (4.3-13.6)5.7 (4.6-7.1)3.6 (2.8-5.5)0.002
TTNT (months; 95%CI)24.3 (14.3-38.1)11.8 (10.1-15.2)8.2 (6.4-10.1)<0.001
Response RateCR: 4/84 (5%)
PR: 18/84 (21%)
SD: 27/84 (32%)
PD: 35/84 (42%)
CR: 30/488 (6%)
PR: 132/488 (27%)
SD: 169/488 (35%)
PD: 157/488 (32%)
CR 9/258 (3%)
PR: 87/258 (34%)
SD: 82/258 (32%)
PD: 80/258 (31%)
0.166

*Interpret with caution as this is a highly selected population in the real-world.

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Abstract Details

Meeting

2024 ASCO Genitourinary Cancers Symposium

Session Type

Poster Session

Session Title

Poster Session C: Renal Cell Cancer; Adrenal, Penile, and Testicular Cancers

Track

Renal Cell Cancer,Adrenal Cancer,Penile Cancer,Testicular Cancer

Sub Track

Quality of Care/Quality Improvement and Real-World Evidence

Citation

J Clin Oncol 42, 2024 (suppl 4; abstr 395)

DOI

10.1200/JCO.2024.42.4_suppl.395

Abstract #

395

Poster Bd #

F19

Abstract Disclosures