Melanoma: a new Targeted Therapy (Anti-PD1, Nivolumab)

-From 2016, articles commented in the Journal and Focus will be posted here (selection by Prof. JH Saurat M.D.)

Melanoma: a new Targeted Therapy (Anti-PD1, Nivolumab)

Postby CFH » Sat May 16, 2015 3:06 pm

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Nivolumab in previously untreated melanoma without BRAF mutation. Robert C. et al. N Engl J Med. 2015 Jan 22;372(4):320-30. doi: 10.1056/NEJMoa1412082. Epub 2014 Nov 16.

Malignant Melanoma (MM) is the most deadly of skin cancers and advanced melanomas need chemotherapy to be effective. (In metastatic melanoma, the 10 year survival rate is under 10%)
Numerous targeted therapies are available. A recent one was Vemurafenib (Zelboraf), a BRAF inhibitor.
The "classical" chemotherapeutic agent used is dacarbazine; it is used as a first line in many countries.
Nivolumab is an antibody against Programmed Death PD-1 pathway.

418 patients with metastatic melanoma(Stage III or IV) were enrolled in the study:
-BRAF receptors were absent
-Before randomization, the expression of PD-L1 (PD-Ligand 1) on the surface of the tumor cells was assessed in a central laboratory. PD-L1 positivity
was defined as at least 5% of tumor cells showing cell-surface PD-L1 (around 35% of patients in both treated groups had positive PD-L1 status)

The figures show the following:
-First figure: overall survival rate in patients taking Dacarbazine vs Nivolumab (Kaplan Meier Curve)
-Second figure: progression-free survival rate in patients taking Dacarbazine vs Nivolumab

-By looking at the curves approximately 70% of patients with Nivolumab survive more than a year, whereas with Dacarbazine, one year survival is around 35%.
-Survival with no disease progression is of one year in approx. 40% of patients with Nivolumab, whereas for Dacarbazine, one year survival is less than 10%.
-Severe (Grade 3 and 4) reactions occurred in around 12% of patients under Nivolumab (6% less than Dacarbazine)

Nivolumab may turn out to be a useful therapeutical option when BRAF-receptor is absent.
It could be useful to compare Ipilimumab (Bristol-Myers Squibb) with Nivolumab to choose the first-line therapy.
HOWEVER: the study was funded by Bristol-Myers Squibb, which develops Nivolumab (BMS-936558,

For the sake of completeness it could also be useful to compare Nivolumab with Vemurafenib (Plexxikon (now part of Daiichi-Sankyo) and Genentech).

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