Efficacy of nivolumab in pre-treated non-small-cell lung cancer patients harbouring KRAS mutations

Francesco Passiglia, Federico Cappuzzo, Oscar Alabiso, Anna Cecilia Bettini, Paolo Bidoli, Rita Chiari, Carlotta Defferrari, Angelo Delmonte, Giovanna Finocchiaro, Guido Francini, Francesco Gelsomino, Diana Giannarelli, Monica Giordano, Alfonso Illiano, Lorenzo Livi, Olga Martelli, Clara Natoli, Gianfranco Puppo, Enrico Ricevuto, Elisa RocaDaniele Turci, Domenico Galetta

Research output: Contribution to journalArticlepeer-review


Background: The present study investigated the efficacy and safety of nivolumab in pre-treated patients with advanced NSCLC harbouring KRAS mutations. Methods: Clinical data and KRAS mutational status were analysed in patients treated with nivolumab within the Italian Expanded Access Program. Objective response rate, progression-free survival and overall survival were evaluated. Patients were monitored for adverse events using the National Cancer Institute Common Terminology Criteria for Adverse Events. Results: Among 530 patients evaluated for KRAS mutations, 206 (39%) were positive while 324 (61%) were KRAS wild-type mutations. KRAS status did not influence nivolumab efficacy in terms of ORR (20% vs 17%, P = 0.39) and DCR (47% vs 41%, P = 0.23). The median PFS and OS were 4 vs 3 months (P = 0.5) and 11.2 vs 10 months (P = 0.8) in the KRAS-positive vs the KRAS-negative group. The 3-months PFS rate was significantly higher in the KRAS-positive group as compared to the KRAS-negative group (53% vs 42%, P = 0.01). The percentage of any grade and grade 3–4 AEs were 45% vs 33% (P = 0.003) and 11% vs 6% (P = 0.03) in KRAS-positive and KRAS-negative groups, respectively. Conclusions: Nivolumab is an effective and safe treatment option for patients with previously treated, advanced non-squamous NSCLC regardless of KRAS mutations.

Original languageEnglish
Pages (from-to)57-62
Number of pages6
JournalBritish Journal of Cancer
Issue number1
Publication statusPublished - Jan 8 2019

ASJC Scopus subject areas

  • Oncology
  • Cancer Research


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