2023 World Conference on Lung Cancer (Posters)-P2.06. Phase I/II Study of Rucaparib and Pembrolizumab Maintenance in Stage IV NSCLC after Carboplatin, Pemetrexed, Pembrolizumab

P2.06. Phase I/II Study of Rucaparib and Pembrolizumab Maintenance in Stage IV NSCLC after Carboplatin, Pemetrexed, Pembrolizumab - PDF(Abstract)

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In this study, the researchers investigated the use of a maintenance therapy regimen consisting of the PARP inhibitor rucaparib and the checkpoint inhibitor pembrolizumab for the treatment of stage IV non-small cell lung cancer (NSCLC) in patients who had previously received standard of care treatment. The standard of care treatment included carboplatin, pemetrexed, and pembrolizumab (CPP) followed by pemetrexed and pembrolizumab (PP) maintenance. The researchers hypothesized that the combination of PARP inhibitor and checkpoint inhibitor would improve progression-free survival (PFS) compared to the standard PP maintenance therapy.<br /><br />The study was conducted as a single-arm, multi-site phase I/II trial and enrolled treatment-naïve patients with non-squamous metastatic NSCLC who were eligible for CPP treatment. Patients who did not experience disease progression after four cycles of CPP received maintenance therapy with rucaparib and pembrolizumab. The primary objective of the study was to assess the efficacy of the regimen in terms of PFS, with secondary objectives including overall survival (OS), safety, and objective response rate (ORR).<br /><br />A total of 25 patients were enrolled in the study, with 14 patients receiving at least one cycle of maintenance therapy. The early results showed a median PFS of 11.4 months and a median OS of 37.6 months in the patients who received maintenance therapy. The ORR was 64%, with no serious adverse events reported and the highest grade of adverse events being Grade 3, primarily liver enzyme elevations and anemia/leukopenia.<br /><br />The study was closed early due to the financial insolvency of the drug manufacturer, Clovis. However, the preliminary results suggest that the combination of PARP inhibitor and pembrolizumab as a maintenance therapy for stage IV non-squamous NSCLC has a manageable safety profile and promising efficacy. Further investigation in larger phase III trials is warranted to better understand the molecular alterations associated with the benefit of PARP inhibitor and pembrolizumab therapy.

Asset Subtitle

Angel Qin

Meta Tag

Speaker Angel Qin

Topic Metastatic NSCLC: Immunotherapy - Prospective

Keywords

maintenance therapy

PARP inhibitor

rucaparib

checkpoint inhibitor

pembrolizumab

stage IV non-small cell lung cancer

NSCLC

standard of care treatment

progression-free survival

phase I/II trial