Randomized, phase III trial of figitumumab in combination with erlotinib versus erlotinib alone in patients with nonadenocarcinoma nonsmall-cell lung cancer.
BACKGROUND
Figitumumab (CP-751,871) is a fully human IgG2 monoclonal antibody that inhibits the insulin-like growth factor 1 receptor. This multicenter, randomized, phase III study investigated the efficacy of figitumumab plus erlotinib compared with erlotinib alone in patients with pretreated, nonsmall-cell lung cancer (NSCLC).


METHODS
Patients (stage IIIB/IV or recurrent disease with nonadenocarcinoma histology) who had previously received at least one platinum-based regimen were randomized to receive open-label figitumumab (20 mg/kg) plus erlotinib 150 mg/day or erlotinib alone every 3 weeks. The primary end point was overall survival (OS).


RESULTS
Of 583 patients randomized, 579 received treatment. The study was closed early by an independent data safety monitoring committee due to results crossing the prespecified futility boundary. At the final analysis, median OS was 5.7 months for figitumumab plus erlotinib and 6.2 months for erlotinib alone [hazard ratio (HR) 1.09; 95% confidence interval (CI) 0.91-1.31; P = 0.35]. Median progression-free survival was 2.1 months for figitumumab plus erlotinib and 2.6 months for erlotinib alone (HR 1.08; 95% CI 0.90-1.29; P = 0.43). Treatment-related nonfatal serious adverse events occurred in 18% and 5% of patients in the figitumumab arm or erlotinib alone arm, respectively. There were nine treatment-related deaths (three related to both drugs, four related to erlotinib alone and two related to figitumumab).


CONCLUSIONS
The addition of figitumumab to erlotinib did not improve OS in patients with advanced, pretreated, nonadenocarcinoma NSCLC. Clinical development of figitumumab has been discontinued.


BACKGROUND
NCT00673049.
Department of Oncology, University of Turin, Orbassano, Turin, Italy giorgio.scagliotti@unito.it.
G V
GV
Scagliotti
Department of Oncology, Dnepropetrovsk Medical Academy, City Multiple-Discipline Clinical Hospital #4, Dnepropetrovsk, Ukraine.
I
I
Bondarenko
Manchester Cancer Research Centre Lung Group, Manchester University and Christie Hospital NHS Foundation Trust, Manchester, UK.
F
F
Blackhall
Department of Multidisciplinary Oncology and Therapeutic Innovations, Aix Marseille University-Assistance Publique Hôpitaux de Marseille, Marseille, France.
F
F
Barlesi
Department of Internal Medicine, China Medical University Hospital and China Medical University, Taichung, Taiwan.
T-C
TC
Hsia
Department of Oncology and Radiotherapy, Medical University of Gdansk, Gdansk.
J
J
Jassem
Department of Pneumology, Oncology and Allergology, Medical University of Lublin, Lublin, Poland.
J
J
Milanowski
Lung Unit, Royal Marsden Hospital, London, UK.
S
S
Popat
Department of Medical Oncology, Hospital de la Princesa, Madrid, Spain.
J M
JM
Sanchez-Torres
Department of Oncology, University of Turin, Orbassano, Turin, Italy.
S
S
Novello
Department of Pfizer Oncology, Pfizer, Inc., Groton, USA.
R J
RJ
Benner
Department of Pfizer Oncology, Pfizer, Inc., Groton, USA.
S
S
Green
Department of Pfizer Oncology, Pfizer, Inc., Groton, USA.
K
K
Molpus
Department of Clinical and Biological Sciences, Institut de Cancérologie Gustave Roussy and INSERM Unit 981, Villejuif, France.
J-C
JC
Soria
Department of Medical Oncology and Hematology, Princess Margaret Cancer Centre, University of Toronto, Ontario, Canada.
F A
FA
Shepherd
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000911:Antibodies, Monoclonal / Q000008:administration & dosage*; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage*; D002289:Carcinoma, Non-Small-Cell Lung / Q000175:diagnosis / Q000188:drug therapy*; D000069347:Erlotinib Hydrochloride / Q000008:administration & dosage*; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008175:Lung Neoplasms / Q000175:diagnosis / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies
D000911:Antibodies, Monoclonal; D000069347:Erlotinib Hydrochloride; C525021:figitumumab
erlotinib; figitumumab; nonsmall-cell lung cancer