93TiP - Patient characteristics after completion of recruitment from the phase 3 IMPALA study with lefitolimod in metastatic colorectal carcinoma (93TiP)

Date 08 December 2017
Event ESMO Immuno-Oncology Congress 2017
Session Lunch & Poster Display session
Topics Anti-Cancer Agents & Biologic Therapy
Pharmacology
Lung and other Thoracic Tumours
Presenter David Cunningham
Citation Annals of Oncology (2017) 28 (suppl_11): xi6-xi29. 10.1093/annonc/mdx711
Authors D. Cunningham1, E. Van Cutsem2, R. Salazar3, M. Ducreux4, W. Scheithauer5, F. Sclafani6, E. Wiegert7, M. Schmidt8, C. Tournigand9, A. Sobrero10, D. Arnold11
  • 1Medicine, The Institute of Cancer Research/Royal Marsden NHS Foundation Trust, SM2 5PT - Sutton/GB
  • 2Digestive Oncology, University Hospitals Leuven, 3000 - Leuven/BE
  • 3Hospital Duran I Reynals, Institut Català d'Oncologia, 08907 - Barcelona/ES
  • 4Institut De Cancérologie, Gustave Roussy, 94805 - Villejuif/FR
  • 5Int.med.i & Ccc, Vienna General Hospital (AKH) - Medizinische Universität Wien, 1090 - Vienna/AT
  • 6The Institute Of Cancer Research, Royal Marsden NHS Foundation Trust, SM2 5PT - Sutton/GB
  • 7Clinical Development, Mologen AG, 14195 - Berlin/DE
  • 8Translational Research, Mologen AG, 14195 - Berlin/DE
  • 9Onkologie Médicale, Centre hospitalier universitaire Henri-Mondor, 94010 - Créteil/FR
  • 10Department Of Medical Oncology, IRCCS AOU San Martino - IST-Istituto Nazionale per la Ricerca sul Cancro, 16132 - Genova/IT
  • 11Oncologia, Instituto CUF, 1350-070 - Lisbon/PT

Abstract

Background

The TLR9 agonist lefitolimod is a covalently-closed dumbbell-like immune surveillance reactivator with a broad immunomodulatory potential. After promising data from the phase 2 IMPACT trial as maintenance therapy after 1st line induction chemotherapy in patients with metastatic colorectal cancer (mCRC) lefitolimod is now evaluated in the phase 3 IMPALA trial in mCRC patients.

Trial design

The international, multicenter, randomized, open-label phase 3 IMPALA trial is conducted in collaboration with the AIO, TTD and GERCOR cooperative groups (NCT02077868). IMPALA’s primary endpoint is OS; secondary endpoints include PFS, response rates, and safety. Induction treatment, CEA and activated NKT are stratification factors for prospective assessment. Patients having achieved an objective tumor response following 1st line induction therapy receive lefitolimod switch maintenance monotherapy or local standard of care (control). In case of relapse, patients will reintroduce induction treatment, whenever feasible, with those in the experimental arm continuing to receive lefitolimod therapy in the weeks without infusion of chemotherapy. Recruitment took 32 months from Sep 2014 until May 2017 to include 549 of 630 patients screened; with unresectable mCRC and ‘fit for chemotherapy’. Sites from 8 European countries participated and accrued 274 patients in the lefitolimod and 275 in the control arm (Austria, 6 patients; Belgium, 8; Estonia, 34; France, 87; Germany, 191; Italy, 54; Spain, 132; UK, 37). 116 female (42.3%) and 158 male (57.7%) were included into the lefitolimod and 92 female (33.5%) and 183 male (66.5%) into the control arm. The median age is 65 years both in the lefitolimod and the control arm. Age group distribution showed also a similar pattern: 12 vs 7 patients from 24-43 yo, 112 vs 114 from 44-63 yo, 56 vs 55 from 64-68 yo, 37 vs 46 from 69-73 yo, 35 vs 37 from 74-78 yo, 19 vs 15 from 79-83 yo and 3 vs 1 from 84-88 yo in the lefitolimod vs the control arm as pre-requisite to guide maintenance therapy in the future.

Clinical trial identification

NCT02077868

Legal entity responsible for the study

Mologen AG

Funding

Mologen AG

Disclosure

D. Cunningham, E. Van Cutsem, R. Salazar, M. Ducreux, W. Scheithauer, C. Tournigand, A. Sobrero, D. Arnold: Member of the IMPALA Steering Committee. F. Sclafani: Investigator of the IMPALA trial. E. Wiegert, M. Schmidt: Employee of MOLOGEN AG.