Oops, you're using an old version of your browser so some of the features on this page may not be displaying properly.

MINIMAL Requirements: Google Chrome 24+Mozilla Firefox 20+Internet Explorer 11Opera 15–18Apple Safari 7SeaMonkey 2.15-2.23

Immunotherapy of cancer

5493 - Interim Analysis of the Phase 3 ADAPT Trial Evaluating Rocapuldencel-T (AGS-003), an Individualized Immunotherapy for the Treatment of Newly-Diagnosed Patients with Metastatic Renal Cell Carcinoma (mRCC)

Date

11 Sep 2017

Session

Immunotherapy of cancer

Topics

Cancers in Adolescents and Young Adults (AYA);  Immunotherapy;  Renal Cell Cancer

Presenters

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

Author affiliations

  • 1 Division Of Hematology Oncology, Cedars-Sinai Medical Center, 90048 - Los Angeles/US
  • 2 Research And Development, Argos Therapeutics, 27704 - Durham/US
  • 3 Gu Medical Oncology, MD Anderson Cancer Center, 77030-3721 - Houston/US
  • 4 Medical Oncology, University of Washington and Fred Hutchinson Cancer Research Center, Seattle/US
  • 5 Surgical Oncology, Foz Chase Cancer Center, 19111 - Philadelphia/US
  • 6 Department Of Urology, Emory University, 30322 - Atlanta/US
  • 7 Urology, Spectrum Health Cancer Center, 49546 - Grand Rapids/US
  • 8 Urology, UT M.D. Anderson Cancer Center, Houston/US
More

Resources

Login to access the resources on OncologyPRO.

If you do not have an ESMO account, please create one for free.

Abstract 5493

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.

This site uses cookies. Some of these cookies are essential, while others help us improve your experience by providing insights into how the site is being used.

For more detailed information on the cookies we use, please check our Privacy Policy.

Customise settings
  • Necessary cookies enable core functionality. The website cannot function properly without these cookies, and you can only disable them by changing your browser preferences.