Extension of overall survival in patients with metastatic renal cell carcinoma who received HD IL-2 followed by targeted therapy and/or immune checkpoint blockade from the PROCLAIM registry.

Authors

null

Joseph Clark

Loyola University Medical Center, Maywood, IL

Joseph Clark , David F. McDermott , Janice P. Dutcher , Michael K.K. Wong , Howard Kaufman , Gregory A. Daniels , Michael Morse , Jessica C. Perritt , Hong Hua , Tharaknath Rao

Organizations

Loyola University Medical Center, Maywood, IL, Beth Israel Deaconess Medical Center, Boston, MA, Cancer Research Foundation, Chappaqua, NY, University of Southern California, Los Angeles, CA, Rutgers Cancer Institute of New Jersey, New Brunswick, NJ, University of California, San Diego, Moores Cancer Center, La Jolla, CA, Duke University Medical Center, Durham, NC, Prometheus Laboratories Inc., San Diego, CA, Prometheus Laboratories Inc, San Diego, CA

Research Funding

Pharmaceutical/Biotech Company

Background: High dose IL-2 (HD IL-2) can provide durable responses in patients with metastatic renal cell carcinoma (mRCC). PROCLAIM (www.proclaimregistry.com, NCT01415167) is an IL-2 registry with over 44 participating sites that captures real-world patient population survival and outcomes. Herein, we report on contemporary patient experience sequencing HD IL-2 with targeted therapy (TT) and immune checkpoint blockade (ICB) in mRCC. Methods: Patients were prospectively enrolled into the registry as of 2011 and must have received at least one dose of HD IL-2 for this analysis. Statistics and survival analysis were performed on datasets as of December 2, 2015. Results: The mOS for all mRCC patients (n=411) was not reached (NR), with a median follow-up of 21 months. The overall response rate (ORR) for the 382 patients with available data was 17.8%. The mOS for those who experienced complete response (CR, n=15), partial response (PR, n=53), or stable disease (SD, n=145) was not reached while in patients with progressive disease (PD, n=169), mOS was 17 months. Survival for patients treated with TT or ICB following HD IL-2 were further analyzed and described in Table 1. Treatments prior to HD IL-2 include chemotherapy (n=12), TT (n=74), immunotherapy (n=8), radiation (n=64), and surgery (n=389). Conclusions: This analysis of the national IL-2 registry reveals that HD IL-2 therapy followed by TT and/or ICB is potentially associated with survival benefit. HD IL-2 continues to be a valuable treatment option for eligible patients with mRCC. Clinical trial information: NCT01415167

Survival for patients with and without therapy after HD IL-2.

Groups
(treatment after HD IL-2)
NmOS
(months)
1, 2, 3 Year
Survival (%)
Targeted Therapy19035.581,63,50
Targeted Therapy & Immune
Checkpoint Blockade
13 (12 aPD-1, 1 aPD-1 +aCTLA-4)NR100,80,80
Immune Checkpoint Blockade12 (7 aPD-1, 2 aPDL-1, 3 aPD-1+aCTLA-4)NR90,79,79
No Targeted Therapy or Immune
Checkpoint Blockade
196NR76,65,65

TT may include inhibitors of VEGF, mTOR, or, EGFR pathways.

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Abstract Details

Meeting

2016 ASCO Annual Meeting

Session Type

Poster Session

Session Title

Genitourinary (Nonprostate) Cancer

Track

Genitourinary Cancer—Kidney and Bladder

Sub Track

Kidney Cancer

Clinical Trial Registration Number

NCT01415167

Citation

J Clin Oncol 34, 2016 (suppl; abstr 4548)

DOI

10.1200/JCO.2016.34.15_suppl.4548

Abstract #

4548

Poster Bd #

170

Abstract Disclosures

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