Memorial Sloan Kettering Cancer Center, New York, NY
Robert J. Motzer , Padmanee Sharma , David F. McDermott , Saby George , Hans J. Hammers , Sandhya Srinivas , Scott S. Tykodi , Jeffrey Alan Sosman , Giuseppe Procopio , Elizabeth R. Plimack , Daniel E. Castellano , Howard Gurney , Frede Donskov , Petri Bono , John Wagstaff , Thomas Christoph Gauler , Takeshi Ueda , Huanyu Zhao , Ian M Waxman , Bernard Escudier
Background: Based on assessment by an independent Data Monitoring Committee, a phase III trial of NIVO (n=410) vs EVE (n=411) in previously treated patients with advanced or metastatic RCC (NCT01668784) was halted early as it met its endpoint; superior overall survival (OS) was seen with NIVO vs EVE. We present outcomes by key baseline factors, prior therapy, and subsequent anticancer therapy. Methods: Patients with 1 or 2 prior anti-angiogenic therapies and measurable disease (RECIST v1.1) were randomized 1:1 to NIVO 3 mg/kg IV every 2 weeks or EVE 10 mg orally once daily. Primary endpoint was OS. A key secondary endpoint was objective response rate (ORR). Results: The Table shows OS and ORR by key baseline factors. Median follow-up was 17-18 mo. 77% and 23% of patients received 1 or 2 prior anti-angiogenic therapies, respectively, for advanced RCC, mainly sunitinib (63%) or pazopanib (32%). In patients who had prior sunitinib, median OS was 23.6 mo for NIVO vs 19.8 mo for EVE; in those who had prior pazopanib, median OS was not estimable (NE) for NIVO vs 17.6 mo for EVE. For those who had prior IL-2 (10%), median OS was NE for NIVO vs 17.2 mo for EVE. Outcomes by subsequent anticancer therapy are planned. Conclusions: A consistent OS benefit with NIVO vs EVE was found across baseline factors (Karnofsky performance status [KPS], Heng risk group, number of prior therapies), and specific prior therapies (sunitinib, pazopanib, IL-2) in previously treated patients with advanced RCC. ORR benefit with NIVO was also seen across baseline factors. Clinical trial information: NCT01668784
N | Median OS, mo (95% CI) | ORR, % (95% CI) | |||
---|---|---|---|---|---|
NIVO | EVE | NIVO | EVE | ||
KPS, % | |||||
90–100 | 540 | NE (26.7–NE) | 29.0 (24.3–NE) | 26.1 (21.0–31.7) | 6.8 (4.1–10.6) |
<90 | 281 | 18.1 (14.3–22.2) | 10.1 (7.9–12.8) | 23.1 (16.3–31.2) | 2.7 (0.7–6.8) |
Heng risk group | |||||
Favorable | 125 | NE | 29.0 (24.7–NE) | 23.6 (13.2–37.0) | 7.1 (2.4–15.9) |
Intermediate | 483 | NE (21.4–NE) | 19.9 (17.7–26.2) | 24.4 (19.1–30.3) | 5.0 (2.6–8.5) |
Poor | 179 | 15.3 (10.6–20.4) | 8.4 (5.9–11.4) | 30.2 (21.3–40.4) | 4.8 (1.3–11.9) |
Prior anti-angiogenic therapies | |||||
1 | 629 | 23.6 (20.8–NE) | 19.9 (17.7–24.7) | 24.3 (19.7–29.4) | 5.4 (3.2–8.6) |
2 | 189 | NE (18.1–NE) | 18.4 (14.0–NE) | 27.8 (18.9–38.2) | 5.1 (1.7–11.4) |
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Abstract Disclosures
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