Neoadjuvant chemo-immunotherapy for the treatment of stage IIIA resectable non-small-cell lung cancer (NSCLC): A phase II multicenter exploratory study—Final data of patients who underwent surgical assessment.

Authors

null

Mariano Provencio

Hospital Puerta de Hierro de Majadahonda, Madrid, Spain

Mariano Provencio , Ernest Nadal , Amelia Insa , Rosario Garcia-Campelo , Joaquín Casal Rubio , Manuel Domine , Margarita Majem , Delvys Rodriguez-Abreu , Alex Martinez Marti , Manuel Cobo , Guillermo Lopez-Vivanco , Elvira del Barco , Reyes Bernabé , Nuria Vinolas , Isidoro Barneto , Santiago Viteri , Paloma Martín-Martorell , Maria Jove , Fabio Franco , Bartomeu Massuti

Organizations

Hospital Puerta de Hierro de Majadahonda, Madrid, Spain, Institut Català d’Oncologia, L’Hospitalet, Barcelona, Spain, Hospital Clinico Universitario de Valencia, Valencia, Spain, University Hospital A Coruña, Coruña, Spain, Complejo Hospitalario Universitario de Vigo, Vigo, Spain, Oncology Department and Translational Oncology Division, University Hospital Fundacion Jimenez Diaz, Madrid, Spain, Hospital De Sant Pau, Barcelona, Spain, Hospital Universitario Insular de Gran Canaria, Las Palmas De Gran Canaria, Spain, Vall d´Hebron University Hospital /Vall d´Hebron Institute of Oncology (VHIO), Barcelona, Spain, Hospital Regional Universitario de Malaga, Málaga, Spain, Department of Medical Oncology, Hospital de Cruces, Barakaldo, Spain, Medical Oncology Department, Salamanca University Hospital, Salamanca, Spain, Hospital Valme, Seville, Spain, Hospital Clinic, Barcelona, Spain, Hospital Reína Sofía, Córdoba, Spain, Pangaea Biotech, Clinical Unit, Barcelona, Spain, Hospital Clinic Universitario de Valencia, Valencia, Spain, Medical Oncology Department, Institut Català d’Oncologia, l’Hospitalet de Llobregat, Barcelona, Spain, Hospital Universitario Puerta de Hierro, Majadahonda-Madrid, Spain, Alicante University Hospital ISABIAL, Alicante, Spain

Research Funding

Pharmaceutical/Biotech Company

Background: Patients with stage IIIA (N2 or T4N0) are potentially curable but median overall survival is only around 15 months and complete pathologic response with conventional chemotherapy (CT) is no more than 9%. Methods: A Phase II, single-arm, open-label multicenter study of resectable stage IIIA N2-NSCLC adult patients with CT plus IO as a neoadjuvant treatment: three cycles of Nivolumab (NV) 360mg IV Q3W + paclitaxel 200mg/m2 + carboplatin AUC 6 IV Q3W followed by adjuvant NV treatment for 1 year. After complete neoadjuvant therapy, tumor assessment is performed prior to surgery. Surgery is performed in the 3rd or 4th week after day 21 of the third cycle of neoadjuvant treatment. The study aims to recruit 46 pts. The primary endpoint is Progression-Free Survival (PFS) at 24 months. Efficacy is explored using objective pathologic response criteria. We present final data on all patients included in this study that underwent surgical assessment. Results: At the time of submission, 46 pts had been included and 41 had undergone surgery. CT-IO was well-tolerated and surgery was not delayed in any patient. None of the pts withdrew from the study preoperatively due to progression or toxicity. 41 surgeries had been performed and all tumors were deemed resectable, with R0 resection in all cases. 34 pts (83%) achieved major pathologic response (MPR) (CI 95% 71-95%), and 24 (71%) of them had a complete pathologic response (CPR) (CI 95% 54-87%). Downstaging was seen in 90% (CI 95% 81-100%) of cases. By RECIST, 29 pts (71%) (CI 95% 56-85%) had partial response and 3 (7%) (CI 95% 0-16%) complete response. Conclusions: This is the first multicentric study to CT-IO in the neoadjuvant setting in stage IIIA. Neoadjuvant CT-IO with nivolumab in resectable IIIA NSCLC yields a high complete pathologic response rate that has never been seen previously and unsuspected by RECIST criteria. Preliminary correlative analyses in blood samples are included in a separate abstract. EudraCT Number: 2016-003732-20. Clinical trial information: NCT 03081689.

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Abstract Details

Meeting

2019 ASCO Annual Meeting

Session Type

Poster Discussion Session

Session Title

Lung Cancer—Non-Small Cell Local-Regional/Small Cell/Other Thoracic Cancers

Track

Lung Cancer

Sub Track

Local-Regional Non–Small Cell Lung Cancer

Clinical Trial Registration Number

NCT 03081689

Citation

J Clin Oncol 37, 2019 (suppl; abstr 8509)

DOI

10.1200/JCO.2019.37.15_suppl.8509

Abstract #

8509

Poster Bd #

265

Abstract Disclosures