Publication-only abstracts (abstract number preceded by an "e"), published in conjunction with the 2019 ASCO Annual Meeting but not presented at the Meeting, can be found online only.
BIOLUMA: A phase II trial of nivolumab in combination with ipilimumab to evaluate efficacy and safety in lung cancer and to evaluate biomarkers predictive for response—Preliminary results from the NSCLC cohort.
Metastatic Non-Small Cell Lung Cancer
Lung Cancer—Non-Small Cell Metastatic
2019 ASCO Annual Meeting
J Clin Oncol 37, 2019 (suppl; abstr e20550)
Author(s): Rieke Nila Fischer, Julie George, Andreas H. Scheel, Hans Anton Schloesser, Maria Vehreschild, Peter Brossart, Walburga Engel-Riedel, Frank Griesinger, Christian Grohé, Karl-Otto Kambartel, Jens Kern, Barbara Hermes, Kathrin Nachtkamp, Jens Peter Panse, Martin Sebastian, Markus Lehmann, Rainer Gerhard Wiewrodt, Reinhard Büttner, Roman K. Thomas, Juergen Wolf; Lung Cancer Group Cologne, University of Cologne, Faculty of Medicine and University Hospital of Cologne, Dept. for Internal Medicine, Cologne, Germany; Department of Translational Genomics, Center of Integrated Oncology Cologne–Bonn, Medical Faculty, University of Cologne, Cologne, Germany; Institute of Pathology, University Hospital of Cologne, Cologne, Germany; Department of General, Visceral and Cancer Surgery, University of Cologne, Cologne, Germany; Department I of Internal Medicine, University Hospital of Cologne, and German Centre for Infection Research, partner site Bonn-Cologne, Cologne, Cologne, Germany; University Hospital Bonn, Center for Integrated Oncology, Bonn, Germany; Hospital Cologne-Merheim, Lung Clinic, University Witten/Herdecke, Cologne, Germany; Pius Hospital Oldenburg, University of Oldenburg, Oldenburg, Germany; ELK, Berlin, Berlin, Germany; Lung Cancer Center Bethanien Moers, Moers, Germany; University Hospital Würzburg Comprehensive Cancer Center Mainfranken, Wuerzburg, Germany; Universitätskinikum Tübingen, Tuebingen, Germany; Duesseldorf University Hospital, Heinrich Heine University, Duesseldorf, Germany; Department of Oncology, Hematology, Hemostaseology and Stem Cell Transplantation, University Hospital RWTH Aachen, Aachen, Germany; University Hospital of Frankfurt, Frankfurt, Germany; Lung Clinic Hemer, Hemer, Germany; Department of Medicine A, University Hospital Muenster, Muenster, Germany; University of Cologne, Faculty of Medicine and University Hospital of Cologne, Institute of Pathology, Cologne, Germany
Background: Patient selection, dosing regimens and resistance mechanisms for immune checkpoint inhibitor combination therapy remain unmet medical needs in lung cancer. Combining blockade of PD-1 and CTLA-4 can be more effective than monotherapy but is accompanied by an increase in toxicity. Thus, to circumvent unnecessary toxicity it is of great interest to identify patients who will benefit from PD-1/PD-L1 blockade alone and to add ipilimumab only in case of primary or secondary progression. We present interim data from the non-small-cell lung cancer (NSCLC) cohort of the ongoing BIOLUMA trial which evaluates efficacy and safety of nivolumab and ipilimumab in lung cancer with a broad translational program to identify potential biomarkers predictive of response and/or resistance including whole exome sequencing (WES) of serial biopsies, functional analysis of peripheral T-cells and gut microbiome analyses. Methods: BIOLUMA is a multicentre non-randomised phase II trial in 2nd line patients with non-squamous NSCLC. Patients are treated with nivolumab 240 mg until disease progression and subsequently with a combination therapy of nivolumab 3 mg/kg q2w and ipilimumab 1mg/kg q6w. Primary endpoint is overall response rate (ORR) after addition of ipilimumab to nivolumab treatment. Analysis of sequential tumor biopsies, blood and gut microbiome is performed at different timepoints. Results: To date, 26 patients have been enrolled and 9 patients were transferred to the combination therapy after progression on nivolumab monotherapy. Drop out rate between the treatment arms is high, mainly due to rapid disease progression and adverse events which don’t allow addition of ipilimumab. ORR is available for 8 of these patients: 6 patients (75%) had PD as best response, and 1 (12.5%) each had a stable disease and partial response, respectively. The patient who achieved a PR had experienced primary tumor progression on nivolumab monotherapy before. Toxicity rate was similar to what has been reported from other trials. Conclusions: In NSCLC, addition of ipilimumab to nivolumab in nivolumab refractory patients seems to be safe, but the response rate is low and the drop out between the treatment parts high. Given these data, early termination of this cohort is currently discussed. Clinical trial information: NCT03083691