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29 oktober 2017: Bron: Annals of Oncology, Volume 28, Issue suppl_5, 1 September 2017

Immuuntherapie met rocapuldencel-T (AGS-003) een vorm van gepersonaliseerde dendritische celtherapie met stimulatie van de T-cellen voor nieuw gediagnosteerde patiënten met reeds uitgezaaide niercelkanker is al eerder door de FDA goedgekeurd nadat uitstekende resultaten uit de fase II en fase III studie (ADAPT studie) waren aangetoond. De ADAPT studie werd gestopt met het werven van patiënten nadat de statistische significantie was bereikt. Maar de onderzoekers bleven / blijven de patiënten wel volgen om een overall overlevingsvergelijking te kunnen maken met beste zorg.

nierkanker 2

Afgelopen week werden weer tussenevaluaties opgemaakt en gepubliceerd in Annals of Oncology. En daarin werden de eerdere resultaten bevestigd:

De mediane duur van deze follow-up presentatie was 20 maanden of langer en meer dan de helft van de patiënten leefde nog in beide groepen, dus ook die in de groep van beste zorg). Data van de eerste groep patiënten, een derde van de totale groep patiënten  (n = 154), en daarvoor de langste tijd zijn gevolgd suggereert een statistisch significant verschil in potentiële overall overleving voor de groep die rocapuldencel-T kreeg.

Aanvullend werd een statistisch significant verschil gezien voor de stijging van de door de rocapuldencel-T aanpak aangemaakte T cellen (CD8+/CD28+/CD45RA-) en betere overall overleving voor die patiënten die  7 doses van de rocapuldencel-T cellen hadden gekregen (n = 114).

Deze resultaten coresponderen met de resultaten uit 2015 van een fase II studie bij 13 patienten die na sunitinib immmuuntherapie hadden gekregen met dendritische celtherapie met toen nog onder codenaam AGS-003 de rocapuldencel-T aanpak

Figure 2

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Object name is 40425_2015_55_Fig2_HTML.jpg

Overall survival. Kaplan-Meier estimates of overall survival (months) for all patients and by patients in Heng intermediate and poor risk factor groups. Similar results were obtained for MSKCC intermediate (39.5 months) and poor (7.9 months) risk factor group.

In de fase III ADAPT studie zijn tussen februari 2013 en oktober 2015 462 patiënten die bij de diagnose al uitgezaaide nierkanker hadden gerandomiseerd ingedeeld in een 2:1 verhouding tussen immuuntherapie met rocapuldencel-T (AGS-003) of beste zorg. Nadat 75% van de beoogde sterfgevallen waren bereikt en een statistisch significant verschil was bereikt met de beste zorggroep  (0.98) werd de studie stopgezet.

Maar met de FDA werd afgesproken om de patiënten wel te blijven volgen.

Hieronder het persbericht / abstract van de interim analyse: 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)

en het abstract van het volledige studierapport: Survival with AGS-003, an autologous dendritic cell–based immunotherapy, in combination with sunitinib in unfavorable risk patients with advanced renal cell carcinoma (RCC): Phase 2 study results die gedetailleerd beschrijft hoe immuuntherapie met rocapuldencel-T (AGS-003) wordt toegediend.

AGS-003 in combination with sunitinib was well tolerated and yielded supportive immunologic responses coupled with extension of median and long-term survival in an unselected, intermediate and poor risk prognosis mRCC population.

J Immunother Cancer. 2015; 3: 14.
Published online 2015 Apr 21. doi:  10.1186/s40425-015-0055-3
PMCID: PMC4404644

Survival with AGS-003, an autologous dendritic cell–based immunotherapy, in combination with sunitinib in unfavorable risk patients with advanced renal cell carcinoma (RCC): Phase 2 study results

Asim Amin,corresponding author Arkadiusz Z Dudek, Theodore F Logan, Raymond S Lance, Jeffrey M Holzbeierlein, Jennifer J Knox, Viraj A Master, Sumanta K Pal, Wilson H Miller, Jr, Lawrence I Karsh, Irina Y Tcherepanova, Mark A DeBenedette, W Lee Williams, Douglas C Plessinger, Charles A Nicolette, and Robert A Figlincorresponding author



AGS-003 is an autologous immunotherapy prepared from fully matured and optimized monocyte-derived dendritic cells, which are co-electroporated with amplified tumor RNA plus synthetic CD40L RNA. AGS-003 was evaluated in combination with sunitinib in an open label phase 2 study in intermediate and poor risk, treatment naïve patients with metastatic clear cell renal cell carcinoma (mRCC).


Twenty-one intermediate and poor risk patients were treated continuously with sunitinib (4 weeks on, 2 weeks off per 6 week cycle). After completion of the first cycle of sunitinib, patients were treated with AGS-003 every 3 weeks for 5 doses, then every 12 weeks until progression or end of study. The primary endpoint was to determine the complete response rate. Secondary endpoints included clinical benefit, safety, progression free survival (PFS) and overall survival (OS). Immunologic response was also monitored.


Thirteen patients (62%) experienced clinical benefit (9 partial responses, 4 with stable disease); however there were no complete responses in this group of intermediate and poor risk mRCC patients and enrollment was terminated early. Median PFS from registration was 11.2 months (95% CI 6.0, 19.4) and the median OS from registration was 30.2 months (95% CI 9.4, 57.1) for all patients. Seven (33%) patients survived for at least 4.5 years, while five (24%) survived for more than 5 years, including 2 patients who remain progression-free with durable responses for more than 5 years at the time of this report. AGS-003 was well tolerated with only mild injection-site reactions. The most common adverse events were related to expected toxicity from sunitinib therapy. In patients who had sequential samples available for immune monitoring, the magnitude of the increase in the absolute number of CD8+ CD28+ CD45RA effector/memory T cells (CTLs) after 5 doses of AGS-003 relative to baseline, correlated with overall survival.


AGS-003 in combination with sunitinib was well tolerated and yielded supportive immunologic responses coupled with extension of median and long-term survival in an unselected, intermediate and poor risk prognosis mRCC population.

Clinical Trial Registry


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)

Annals of Oncology, Volume 28, Issue suppl_5, 1 September 2017, mdx376.003,
18 September 2017

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.


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