Updated data from PROCLAIM national patient registry presented at 51st ASCO

Prometheus Laboratories, Inc. announced today the presentation of updated data from the PROCLAIM^SM national patient registry in which first-line Proleukin^® (aldesleukin for injection) therapy improved survival in patients with metastatic renal cell carcinoma (mRCC), compared to patients previously treated with targeted therapies. In a presentation at the 51st annual meeting of the American Society of Clinical Oncology (ASCO), researchers presented updated survival data from the PROCLAIM mRCC retrospective cohort, along with new data from the mRCC prospective cohort, that confirm the benefits of administering Proleukin in the first-line setting, showing that careful patient selection and drug sequencing may yield better treatment outcomes.

"The latest PROCLAIM data, which include the first report from the prospective cohort of patients with metastatic RCC, are consistent with previously reported survival data from the retrospective cohort," said lead investigator Joseph I. Clark, MD, FACP, Professor of Medicine in the Division of Hematology/Oncology at Loyola University Medical Center in Maywood, IL. "In both cohorts, first-line high-dose interleukin-2 immunotherapy was associated with prolonged survival, compared to patients who first received targeted therapies. The survival benefit extended to patients previously categorized with stable disease, a population that had been grouped with non-responders to high-dose IL-2 therapy."

In the presentation entitled, "Impact of Targeted Therapy (TT) on Survival of Metastatic Renal Cell Carcinoma (mRCC) Patients Treated with High Dose Interleukin-2 (HD IL-2): Analysis of the PROCLAIM HD IL-2 National Registry" (abstract #146529), Dr. Clark and colleagues unveiled the first results from 123 patients with mRCC enrolled in the prospective PROCLAIM cohort, along with updated overall survival (OS) data from the retrospective cohort. The overall response rate (ORR) in the prospective cohort was 17.9%. Patients from the prospective cohort who experienced a complete response (CR), partial response (PR), and stable disease (SD) had 2.5-year survival rates of 100%, 87%, and 73%, respectively. The median overall survival rate (mOS) in the prospective cohort was 29.6 months at a median follow-up of 23.2 months. The mOS was not reached (NR) in prospective-cohort patients treated with Proleukin only, compared to 13.1 and 29.6 months in those who had prior or post-Proleukin targeted therapy. Reported treatment-related mortality rate in the combined retrospective and prospective cohorts was 0.9% (4/435).

"Median overall survival in the PROCLAIM prospective cohort exceeds that observed in the studies that led to regulatory approval of IL-2 prior to the availability of tyrosine kinase inhibitor therapy, suggesting that proper sequencing of IL-2 and targeted therapies may enable improved outcomes in appropriate patients," added co-investigator Michael Morse, MD, Professor of Medicine at Duke University School of Medicine. "As we continue to collect data in the prospective cohort, we hope to refine our understanding of which candidates are most likely to benefit from sequential therapy, and to use this knowledge to extend patients' lives."