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Nivo Retreatment in Advanced NSCLC: French I-O Optimize Study

January, 01, 2024 | Lung Cancer, NSCLC (Non-Small Cell Lung Cancer)

KEY TAKEAWAYS

  • The ESME LC observational study aimed to investigate the real-world retreatment patterns and outcomes in NSCLC pts following 2L+ nivo therapy.
  • Researchers observed longer OS in NSCLC pts compared to those choosing rechallenge after discontinuation of 2L+ nivo.

While clinical trials highlight the efficacy of immune checkpoint inhibitors (ICIs) in non-small cell lung cancer (NSCLC), real-world data on ICI retreatment patterns post-2L+ nivolumab (nivo) therapy remains limited. This study delves into the unexplored realm of real-world scenarios among NSCLC patients (pts) in France, aiming to unravel the nuances of ICI retreatment outcomes and patterns.

Gregoire Justeaux and his team aimed to provide a comprehensive understanding of how NSCLC pts navigate treatment decisions after 2L+ nivo, shedding light on the prevalent patterns and real-world outcomes associated with ICI retreatment.

The study performed an inclusive analysis including pts diagnosed with locally advanced/metastatic NSCLC who initiated 2L+ nivo treatment between 2015 and 2020. This retrospective observational cohort was conducted within the ESME-AMLC framework, spanning 39 medical centers across France (ClinicalTrials.gov identifier: NCT03848052).

Patient inclusion criteria involved those initiating 2L+ nivo during the specified timeframe, with data encompassing demographics, clinical characteristics, retreatment details, and overall outcomes. The retrospective observational design aimed to capture a comprehensive view of the real-world landscape for NSCLC pts within the French healthcare system.

The study meticulously tracked pts from the initiation of 2L+ nivo to the last available medical information date, allowing for a thorough examination of retreatment patterns and associated clinical outcomes. Retreatments were categorized into distinct patterns: rechallenge (any ICI following a non-ICI anticancer treatment post-2L+ nivo discontinuation), resumption (any ICI post-treatment break >6 weeks), and ICI switch (any non-nivo ICI post-treatment break <6 weeks). These classifications provided a nuanced understanding of the diverse approaches NSCLC pts adopted in their treatment journey.

After a median follow-up of 24 weeks, 2985 out of 4001 pts (74.6%) discontinued 2L+ nivo treatment. Among them, 1604 individuals (40.1%) opted for chemotherapy (CT) or targeted therapy, 800 pts (20%) did not pursue further treatment, and 226 pts (7.6%) underwent immune checkpoint inhibitor (ICI) retreatment. Of those who retreated with ICI, 110 pts (48.7%) chose rechallenge with a median treatment duration of 2.1 months, 102 pts (45.1%) opted for resumption with a median treatment duration of 3.3 months, and 14 pts (6.2%) switched ICI. Notably, the majority of pts with ICI exhibited non-squamous histology, accounting for 80 (72.7%) in rechallenge, 76 (74.5%) in resumption, and 12 (85.7%) in ICI switch categories.

The median duration of the initial nivo treatment varied across retreatment patterns: 5.5 months for rechallenge, 7 months for resumption, and 7 months for ICI switch. The median overall survival (OS) from the retreatment date was 16.6 months for pts retreated with ICI, contrasting with 8.3 months for those who opted for resumption or rechallenge. Notably, pts who initially received 2L+ nivo for >26 weeks exhibited higher ICI retreatment rates (15.8% overall) than pts who received 2L+ nivo for <13 weeks (3.6% overall).

The study concluded that, following the discontinuation of 2L+ nivo treatment, a predominant number of pts opted for chemotherapy (CT), with only a minority choosing immune checkpoint inhibitor (ICI) retreatment. However, it was observed that the incidence of ICI retreatment increased with the duration of 2L+ nivo therapy. Notably, pts who resumed ICI exhibited longer OS compared to those who underwent rechallenge.

The study is sponsored by UNICANCER

Source: https://cslide.ctimeetingtech.com/immuno23hybrid/attendee/confcal/show/session/34

Clinical Trial: https://clinicaltrials.gov/study/NCT03848052

Justeaux G, et al. (2023). “Immune checkpoint inhibitor (ICI) retreatment patterns and outcomes in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) who received second-line or later (2L+) nivolumab (nivo): A French I-O Optimise analysis.” Presented at ESMO IO 2023 (Abstract 76P).

 

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