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June 3rd, 2016

Phase 1 Data Published in Lancet

Phase 1 data published in Lancet show Nivolumab monotherapy and nivolumab plus ipilimumab showed antitumour activity with durable responses and manageable safety profiles in previously treated patients with Small Cell Lung Cancer, START study shows Data suggest a potential new treatment approach for a population of patients with limited treatment options

NOTE: Results from the Checkmate 032 study, will be presented at ASCO in a Clinical Science Symposium at 8 a.m. Saturday, June 4, in Hall D1 at McCormick Place, and will be published in the June issue of Lancet Oncology

(MADRID, Spain) June 3, 2016 -- Small-cell lung cancer (SCLC) accounts for 14% of diagnosed lung cancers and is usually associated with a history of smoking. It is named after the size of the cancer cells when viewed under a microscope.  Patients with SCLC have very limited treatment options. Results from a new study conducted by START researchers being presented at the American Society of Clinical Oncology and published in The Lancet Oncology suggest a potential new treatment approach for a population of patients with limited treatment options and support the evaluation of nivolumab and nivolumab plus ipilimumab in phase 3 randomised controlled trials in SCLC.

Most patients present with extensive-stage disease characterized by widespread metastases and poor survival. Although 35-86% of patients with SCLC respond to first line chemotherapy, disease progresses rapidly, and outcomes with second-line treatment are poor.

START participated in Checkmate 032, a multicenter, open-label, two-stage, multi-arm phase 1/2 trial to assess the activity and safety of nivolumab and ipilimumab in 216 patients with SCLC who developed progressive disease after prior standard chemotherapy.

Patients with SCLC were enrolled at 23 sites (academic centers and hospitals) in six countries (Finland, Germany, Italy, Spain, UK, and USA. Seventy two patients from START Madrid participated in the overall study, from where this subgroup analysis for patients with SCLC is being conducted.

In the study, patients received either nivolumab therapy as a single agent, or two different combination regimens of nivolumab plus ipilimumab.

Emiliano Calvo, M.D., Ph.D., Director of the START Madrid Group, served as senior and corresponding author of the study which will be presented at a Clinical Symposium session on this study at ASCO. START Madrid currently operates two Phase I Oncology Units: START Madrid-CIOCC, which opened in 2008, and START Madrid-FJD, launched in 2014 and located in Spain's capital city of six million residents.

Dr. Calvo serves as the director of Clinical Research at START Madrid-CIOCC.

"These data suggest a potential new treatment approach for a population of patients with limited treatment options, and for which we did not have meaningful therapeutic advances as reflected by the fact that we keep treating this disease in the same way we have for the last couple of decades." said Dr. Calvo. "These results also open up the potential of exploring the combination of two immune checkpoint inhibitors in patients with other types of tumors for which no standard of care in advanced lines of treatment exists, since this combo seems to be feasible and of, at least, additive antitumor effects."