798PD - Open-label phase II trial of first-line everolimus monotherapy in patients with advanced papillary renal cell carcinoma: raptor interim analysis

Date 01 October 2012
Event ESMO Congress 2012
Session Genitourinary tumors, non-prostate (renal cancer)
Topics Anti-Cancer Agents & Biologic Therapy
Renal Cell Cancer
Presenter Bernard Escudier
Authors B. Escudier1, S. Bracarda2, J.P. Maroto3, C. Szczylik4, P. Nathan5, S. Negrier6, K. Slimane7, C. May8, C. Porta9, V. Grünwald10
  • 1Institut Gustave Roussy, 94805 - Villejuif/FR
  • 2Department Of Oncology, Ospedale San Donato, Arezzo/IT
  • 3Medical Oncology, Hospital de la Santa Creu i Sant Pau, Barcelona/ES
  • 4Clinical Oncology, Wojskowy Instytut Medyczny, Warsaw/PL
  • 5Cancer Services, Mount Vernon Cancer Centre, Northwood/UK
  • 6Dept. Of Oncology, Centre Leon Berard, Lyon/FR
  • 7Oncology, Novartis Pharmaceuticals, 92500 - Rueil-Malmaison/FR
  • 8Oncology, Novartis Pharma GmbH, 90429 - Nuremberg/DE
  • 9Oncologia Medica, IRCCS San Matteo University Hospital Foundation, Pavia/IT
  • 10Clinic For Hematology, Hemostasis, Oncology, Hannover Medical School, 30625 - Hannover/DE

Abstract

Background

Treatment options for patients with papillary renal cell carcinoma (RCC) are limited. Everolimus, a mammalian target of rapamycin (mTOR) inhibitor, has demonstrated efficacy in clear cell metastatic RCC; mTOR signaling is also dysregulated in papillary RCC. The ongoing RAPTOR (RAD001 in Advanced Papillary Tumor Program in Europe; ClinicalTrials.gov, NCT00688753) trial is evaluating everolimus monotherapy in treatment-naive patients with advanced papillary RCC. Here, we present the results of a preliminary analysis.

Patients and methods

RAPTOR is an open-label, single-arm, multicentre phase II trial. Adult patients with advanced type I or type II papillary RCC and ECOG performance status of 0 or 1 were enrolled. Prior systemic therapy for RCC was not permitted. Patients received oral everolimus 10 mg once daily until disease progression or unacceptable toxicity. The primary end point is proportion of patients progression free at 6 months.

Results

At data cut-off (April 11, 2012), 71 of 92 (77%) enrolled patients were eligible for analysis according to central pathology review (confirmed papillary renal cancer); 16 of the 92 patients were still on treatment. Most patients were men (73%) and most were <65 years of age (73%). Median PFS by investigator's assessment was 219 days (7.3 months; 95% CI, 5.6–15.2 months) and 55.2% of patients were progression free at 6 months. PFS assessment of patients still on treatment, independent radiology review, and safety assessment of all patients is ongoing.

Conclusions

Results of this interim analysis have demonstrated that everolimus provides clinical benefit to patients with advanced papillary RCC. These results support the further evaluation of everolimus as a first-line treatment option for patients with advanced papillary RCC.

Disclosure

B. Escudier: Bernard Escudier has served as a consultant to and received honoraria from Bayer, Pfizer, Roche, Novartis, GlaxoSmithKline, and Aveo.

S. Bracarda: Sergio Bracarda has served as an advisory board member to Pfizer, GlaxoSmithKline, Novartis, and Bayer, and has received honoraria from Pfizer and Novartis.

K. Slimane: Khemaies Slimane is an employee of Novartis Pharma S.A.S.

C. May: Christoph May is an employee of Novartis Pharma GmbH.

C. Porta: Camillo Porta served as consultant/speaker for Novartis, Pfizer, GSK, Hoffman La Roche, Bayer-Schering, Aveo Pharmaceuticals, Astellas, Boehringer Ingellheim, and Recordati and received research grants from Novartis and Bayer-Schering.

V. Grünwald: Viktor Grunwald served as consultant to Roche, Bayer, Novartis, Pfizer, GlaxoSmithKline, and Aveo/Astellas, received honoraria from GlaxoSmithKline, Novartis, and Pfizer, and received research funding from Pfizer and GlaxoSmithKline.

All other authors have declared no conflicts of interest.