1137O - Interim Analysis of the Phase 3 ADAPT Trial Evaluating Rocapuldencel-T (AGS-003), an Individualized Immunotherapy for the Treatment of Newly-Diagno...

Date 11 September 2017
Event ESMO 2017 Congress
Session Immunotherapy of cancer
Topics Cancer in Adolescents
Renal Cell Cancer
Cancer Immunology and Immunotherapy
Genitourinary Cancers
Presenter Robert Figlin
Citation Annals of Oncology (2017) 28 (suppl_5): v403-v427. 10.1093/annonc/mdx376
Authors R. Figlin1, C. Nicolette2, N. Tannir3, S.S. Tykodi4, D. Chen5, V. Master6, B. Lane7, M. Debenedette2, T. Monesmith2, W. Tan2, S. Leland2, C.G. Wood8
  • 1Division Of Hematology Oncology, Cedars-Sinai Medical Center, 90048 - Los Angeles/US
  • 2Research And Development, Argos Therapeutics, 27704 - Durham/US
  • 3Gu Medical Oncology, MD Anderson Cancer Center, 77030-3721 - Houston/US
  • 4Medical Oncology, University of Washington and Fred Hutchinson Cancer Research Center, Seattle/US
  • 5Surgical Oncology, Foz Chase Cancer Center, 19111 - Philadelphia/US
  • 6Department Of Urology, Emory University, 30322 - Atlanta/US
  • 7Urology, Spectrum Health Cancer Center, 49546 - Grand Rapids/US
  • 8Urology, UT M.D. Anderson Cancer Center, Houston/US

Abstract

Background

Rocapuldencel-T is an investigational immunotherapy formulated with RNA isolated from the patient's tumor to program autologous dendritic cells with tumor-specific antigens. It is administered chronically via intradermal injection to activate a tumor-specific memory T-cell response.

Methods

The Phase 3 ADAPT trial was designed to evaluate overall survival (OS) of rocapuldencel-T in combination (Combo) with standard-of-care (SOC) for the treatment of newly diagnosed mRCC as compared to SOC alone (Control). It included adults with synchronous, clear cell mRCC who were eligible for nephrectomy at 107 sites across North America, Europe and Israel.

Results

462 patients were randomized 2:1 from February 2013 - October 2015. In February 2017, an interim analysis by the Independent Data Monitoring Committee after 75% of the targeted number of 290 events (deaths) prompted a recommendation to stop the trial because the OS hazard ratio was greater than the pre-defined futility boundary (0.98) for the 3rd interim assessment. However, in consultation with investigators and the FDA, the sponsor has continued the trial due to the still maturing survival data, the mechanism of action of rocapuldencel-T, which involves the induction of long-term memory immune responses, and its’ safety profile. The median duration of follow-up was 20 months and more than half the patients in both treatment groups were still alive. Data from the first third of patients randomized (n = 154), and, therefore the longest follow up time and least censored data (44%), suggest a potential survival benefit for the combination worthy of further assessment. Additionally, a statistically significant correlation was observed between the increase in the number of rocapuldencel-T induced memory T cells (CD8+/CD28+/CD45RA-) and OS in patients for whom data has been analyzed and 7 doses of rocapuldencel-T has been administered (n = 114). Updated long-term response and immune data will be presented.

Conclusions

The ADAPT trial is ongoing to further assess the long-term effects of this well-tolerated individualized immunotherapy.

Clinical trial identification

NCT01582672

Legal entity responsible for the study

Argos Therapeutics

Funding

Argos Therapeutics

Disclosure

R. Figlin: Institution receives research funding. C. Nicolette, M. Debenedette, T. Monesmith, W. Tan, S. Leland: Employee of Argos Therapeutics. N. Tannir: Grants and/or personal fees and non-financial support from Bristol-Myers Squibb, Exelixis, Nektar, Pfizer, Argos, Calithera, Epizyme, Miranti, outside the submitted work. All other authors have declared no conflicts of interest.