280P - Efficacy of avelumab + axitinib (A + Ax) vs sunitinib (S) by number of IMDC risk factors in patients (pts) with advanced renal cell carcinoma (aRCC): Subgroup analyses from the final analysis of the phase III JAVELIN renal 101 trial

Background

In the phase III JAVELIN Renal 101 trial (NCT02684006), first-line A + Ax showed significantly prolonged progression-free survival (PFS) and a higher objective response rate (ORR) vs S in pts with aRCC, including across pts categorized by International Metastatic RCC Database Consortium (IMDC) risk classification (favorable, intermediate, or poor) or number of IMDC risk factors (0, 1, 2, 3, or ≥4). At the final analysis (follow-up, ≥68 months), overall survival (OS) favored A + Ax vs S, but results did not reach statistical significance. We report exploratory subgroup analyses by the number of IMDC risk factors using data from the final analysis.

Methods

Eligible pts were randomized 1:1 to receive either A + Ax or S. PFS and ORR per investigator assessment (RECIST 1.1) and OS were assessed in pts with 0 IMDC risk factors (favorable risk), 1 or 2 risk factors (intermediate risk), or 3 or ≥4 risk factors (poor risk). OS and PFS were analyzed using the Kaplan-Meier method; unstratified hazard ratios (HRs) are presented.

Results

At data cutoff (31 Aug 2023), median follow-up for OS in the A + Ax and S arms was 73.7 and 73.6 months, respectively. Baseline characteristics were generally well balanced across subgroups defined by the number of IMDC risk factors in both arms. Median OS (mOS), median PFS (mPFS), and ORR across subgroups are shown in the table. OS analyses showed the greatest differences for A + Ax vs S in the 0, 3, and ≥4 risk factor subgroups, whereas PFS and ORR benefits were observed in all subgroups. Table: 280P

Conclusions

Subgroup analyses in pts with aRCC from JAVELIN Renal 101 confirm the long-term efficacy of A + Ax vs S across subgroups defined by number of IMDC risk factors. Outcomes were most improved in subgroups with 0 risk factors (favorable risk) or 3 or ≥4 risk factors (poor risk) vs subgroups with 1 or 2 risk factors (intermediate risk).

Clinical trial identification

NCT02684006, first posted, February 17, 2016.

Editorial acknowledgement

Medical writing support was provided by Katherine Quiroz-Figueroa of Nucleus Global.

Legal entity responsible for the study

Pfizer, as part of a previous alliance between Merck (CrossRef Funder ID: 10.13039/100009945) and Pfizer.

Funding

This trial was sponsored by Pfizer and was previously conducted under an alliance between Merck (CrossRef Funder ID: 10.13039/100009945) and Pfizer. This analysis was sponsored by Merck.

Disclosure

M. Eto: Financial Interests, Personal, Research Funding: Ono Pharmaceutical, Sanofi, Takeda Pharmaceutical; Financial Interests, Personal, Other, honoraria for lectures: Astellas Pharma, AstraZeneca, Bristol Myers Squibb, Janssen Pharmaceutical, Merck, MSD, Ono Pharmaceutical, Pfizer, Takeda Pharmaceutical. R.J. Motzer: Financial Interests, Personal, Advisory Role: AstraZeneca, Aveo, Calithera Biosciences, Eisai, Exelixis, Genentech/Roche, Incyte, Merck, Pfizer; Financial Interests, Personal, Other, travel, accommodations, and expenses: Bristol Myers Squibb; Financial Interests, Personal, Research Funding: Aveo, Bristol Myers Squibb, Eisai, Exelixis, Genentech/Roche, Novartis, Merck, Pfzier. T.K. Choueiri: Financial Interests, Personal, Advisory Board, Advice on GU/RCC drugs: BMS, Pfizer, Merck, Exelixis, AstraZeneca; Financial Interests, Personal, Advisory Board, Advice on Onc drugs: Lilly, EMD Serono, Infinity; Financial Interests, Personal, Advisory Board, Advice on RCC drug: Calithera; Financial Interests, Personal, Invited Speaker, RCC drug: Ipsen; Financial Interests, Personal, Advisory Board, Advice on GU Onc drugs: Surface Oncology; Financial Interests, Personal, Other, Consultant on onc drugs: Analysis Group; Financial Interests, Personal, Invited Speaker, CME, ww2.peerview.com: Peerview; Financial Interests, Personal, Invited Speaker, CME, gotoper.com: PER; Financial Interests, Personal, Invited Speaker, CME, researchtopractice.com: ResearchToPractice; Financial Interests, Personal, Invited Speaker, National Association of Managed Care: NAMC; Financial Interests, Personal, Invited Speaker, ASCO-related event: ASCO-SITC; Financial Interests, Personal, Other, Grant review to Orien Network ($400): ORIEN; 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