Not really news, but once again: ipi/nivo combo is better than ipi alone!

Abstract 2860:  Improved clinical response in patients with advance melanoma treated with nivolumab combined with ipilimumab compared to ipilimumab alone.  Hodi, Postow, Pavlick, Agarwala, Wolchok, et al.  AACR 106th Meeting, April 2015.  Cancer Research.

Treatment-naive patients with advanced melanoma were randomized 2:1 to ipi 3mg/kg combined with nivo 1mg/kg or placebo (ie ipi alone) q3wks for 4 doses, followed by nivo 3mg/kg or placebo...q 2 wks until disease progression or toxicity.  

In BRAF wild type patients:  ORR = 60% in the nivo/ipi group vs 11% in the ipi group.  Complete  response was reported in 12 and 0 patients respectively.  Median change in target lesions was 57% reduction in the nivo/ipi group vs 4% increase for ipi alone.  Median duration of response was not reached in either group.   Median PFS was 8.9 months for combo, 4.7 months for ipi. In BRAF mutation positive patients, the results for ORR and PFS were similar.  

A higher rate of adverse events was noted in the combo group....leading to more frequent discontinuation.  Patients who discontinued the combo due to toxicity had a 67% response rate and most continue to respond.  Immune side effects were manageable with standard treatment interventions, and the majority resolved with immune-modulating meds.

So....stuff we already knew. The ipi/nivo combo provides better response rates and a greater decrease in size of target lesions compared to ipi alone...though with more side effects.  A great pearl: for those who had to stop the combo because of side effects, most CONTINUED TO RESPOND! And...BRAF status seemed to make NO difference.

And.....October 1 there was this:  BMS news release re FDA approval of nivo/ipi combo at least for some

Now why not for everybody...since we KNOW BRAF status is NOT related to success in this instance? Why not folks who are NOT treatment naive....since they may need it more than others? Those peeps may need to be informed that their response rate may be decreased from the treatment naive folks (remember the results from the sequential study!) but what results will they attain without a chance at the combo at all????!  It seems that the FDA has a very strange, tunnel vision approach to science and an inhumane approach to saving lives.  But, step by ever such small steps....we are getting more help to those in need!

Keep on truckin ratties! -c