PHARMACEUTICAL NEWS

• Can NSCLC Histology Affect Response to Therapy and Overall Survival?
  Last month, the United States FDA approved Eli Lilly and Company’s pemetrexed (Alimta®) for use in combination with cisplatin therapy for the first-line treatment of patients with locally advanced or metastatic non-squamous NSCLC. The approval was based on the results of a randomized study of 1,725 chemo-naive patients with stage IIIB/IV NSCLC comparing overall survival (OS) after treatment with either pemetrexed + cisplatin (AC) or gemcitabine + cisplatin (GC). Results: median survival (AC 10.3 months vs GC 10.3 months), median PFS (AC 4.8 months vs GC 5.1 months) and overall response (AC 27.1% vs GC 24.7%).
  
  A pre-specified analysis of the impact of NSCLC histology on OS was conducted in this trial and clinically relevant differences according to histology were observed. In the non-squamous cell NSCLC patient subgroup, median survival was 11.0 months in AC and 10.1 months in GC treated groups, but in the squamous cell histology subgroup the median survival was 9.4 months in AC vs 10.8 months in GC treated patients. This unfavorable effect on OS associated with squamous cell histology observed with pemetrexed was also noted in a retrospective analysis of the single agent trial of pemetrexed vs docetaxel in a similar patient population after prior chemotherapy. Current product labeling has been revised to recommend that pemetrexed is also not indicated in patients with squamous cell lung cancer after prior chemotherapy.
  
  These results demonstrate that NSCLC histology can impact treatment outcome and have an unfavorable effect on patients’ overall survival.
  
  

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