Nivolumab Extends Survival in Advanced Renal Cell Carcinoma

Jason M. Broderick @jasoncology
Published: Friday, Sep 25, 2015

PD-L1 status was not an efficacy biomarker for nivolumab. Among patients with PD-L1 expression ≥1%, median OS was 21.8 months with nivolumab versus 18.8 months with everolimus. In patients with PD-L1 expression ≤1%, median OS was 27.4 and 21.2 months in the two arms, respectively. Similar outcomes were observed when using a 5% threshold for PD-L1 expression status, although only a small number of patients were evaluable by this criterion.

“The finding that overall survival was higher among patients treated with nivolumab, irrespective of PD-L1 expression, suggests that PD-L1 expression should not be used to determine which patients might respond to the therapy and whether or not offer it to them,” said Sharma.

“PD-L1 is a dynamic biomarker that changes over time as a result of evolving immune responses. So it is not surprising that PD-L1 measured in tumor samples before treatment does not capture the true expression of PD-L1 and how it may correlate to responses to treatment. I would expect that tumour samples taken while patients were on-treatment, as opposed to pretreatment, might indicate that PD-L1 expression, as well as other markers of immune response, has a correlation with response to treatment,” Sharma added.  

Nivolumab was initially approved in December 2014 for patients with unresectable or metastatic melanoma following treatment with ipilimumab (Yervoy) or a BRAF inhibitor. In March 2015, the PD-1 inhibitor was approved for the treatment of patients with advanced squamous non–small cell lung cancer (NSCLC) who have progressed on or after platinum-based chemotherapy.

The FDA is currently reviewing applications for frontline nivolumab as a monotherapy and in combination with ipilimumab for patients with advanced melanoma, as well as for an indication for patients with previously treated nonsquamous NSCLC.


References:

  1. Sharma P, Escudier B, McDermott DF, et al. CheckMate 025: a randomised, open-label, phase III study of nivolumab (NIVO) versus everolimus (EVE) in advanced renal cell carcinoma (RCC). Presented at: 2015 European Cancer Congress; September 25-29; Vienna, Austria. Abstract LBA 3.
  2. Motzer RJ, Escudier B, McDermott DF, et al. Nivolumab versus everolimus in advanced renal-cell carcinoma [published online September 25, 2015]. N Engl J Med. doi:10.1056/NEJMoa1510665.

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