Saturday, June 4, 2016

ASCO 2016 - CheckMate 067 - ipi/nivo combo in treatment naive .... and some thoughts....

Running today I was thinking of many things.  Happy to hear the birds and watch Mr. and Mrs.  Towhee.  Happy to be running well...yep, still putting in my miles...despite melanoma...despite weird right arm pit pain that's a given with all my various surgeries in that area and right hip pain that has stabilized a bit....despite turning 52 soon!!!  Thrilled for Mat; his good scans and happy birthdays.  A bit worried for other dear ones facing more treatments and unknowns.  Not overjoyed about my own scans in August.  But, excited about some travel plans, working on my French and Spanish, sewing projects, and my general work and life...  Pondering the loss of a strong man, who I watched as a child with Howard Cosell, never deserving the cage of mind and body that was his Parkinsonian-like condition.  Slightly crushed for another dear one, Reverend Carol, such a strong and encouraging spirit of leadership and strength for many years in melanoma world, now dealing with some melanoma mess of her own.  So....when I think of my own problems and being tired of melanoma info and posting endless data that, while better than any melanoma has ever had, still sucks great big green hairy wizard balls!!!!  I look to real leaders... 

From Muhammed Ali:  "The service you do for others is the rent you pay for your room here on Earth."

From  Rev. Carol Taylor's blog, Attitude of Gratitude, Lets give

"If you have melanoma, find support. Plug into the online community. We are thriving on Facebook. If you aren't on FB, Melanoma Research Foundation has a great page of support (click on Find Support). Be sure to share your story with others. Make a difference. Somehow. You matter. Your journey matters. Others need to hear what you have to say. And who knows? You just might save a life or two though you may never be told.
If you have melanoma, give support. Don't just take it, give it back. We all need cheerleaders in our corner. We all need prayer warriors..."

And yes, my really are....Queen of Melanoma World!!!  I kneel before your tiara and tattoo printed compression sleeves, wishing you well...and doing my best to...give it back.

In that vein, check out the ASCO post below with the results of the ip/nivo study that has already been beat to death in the media and on this blog.  But perhaps, more importantly, I give you this:

"Live every day as it it were your last, because some are going to be right!" ~ Muhammad Ali

Much love, c

Updated results from a phase III trial of nivolumab (NIVO) combined with ipilimumab (IPI) in treatment-naive patients (pts) with advanced melanoma (MEL) (CheckMate 067).  ASCO 2016.  # 9505.  J Clin Oncol 34, 2016.  Wolchok, Chiarion-Sileni, Gonzalez, et al.

Background: In CheckMate 067, NIVO (anti-PD-1) plus IPI (anti-CTLA-4) significantly improved progression-free survival (PFS) and objective response rate (ORR) vs IPI alone in pts with MEL. We report updated efficacy and safety results from this study. Methods: Treatment-naïve pts (N=945) were randomized 1:1:1 to NIVO 1 mg/kg Q3W with IPI 3 mg/kg Q3W for 4 doses (followed by NIVO 3 mg/kg Q2W), NIVO 3 mg/kg Q2W with placebo, or IPI 3 mg/kg Q3W for 4 doses with placebo, until progression or unacceptable toxicity. Pts were stratified by PD-L1 status, BRAFmutation status, and M-stage. Co-primary endpoints were PFS and overall survival (data remain immature). Secondary endpoints included efficacy by PD-L1 status and safety. Results: At greater than or = to, 8 months of follow-up, median PFS continued to be significantly longer for NIVO/IPI and NIVO vs IPI , and was numerically longer for NIVO/IPI vs NIVO alone. Median duration of response in 181/314 (57.6%) NIVO/IPI responders has not been reached, and was 22.3 and 14.4 months in 138/316 (43.7%) NIVO and 60/315 (19.0%) IPI responders, respectively. Median PFS was also numerically longer with NIVO/IPI vs NIVO or IPI regardless of PD-L1 tumor expression. For NIVO/IPI, NIVO, and IPI groups, median PFS was 15.5, 5.6, and 4.0 months in pts with a BRAF mutation and was 11.3, 7.1, and 2.8 months in pts with wild-type BRAF, respectively. The frequency and types of drug-related grade 3/4 AEs were consistent with earlier reports (NIVO/IPI, 56.5%; NIVO, 19.8%; IPI, 27.0%). Conclusions: NIVO/IPI and NIVO alone continue to demonstrate superior clinical activity vs IPI monotherapy. NIVO/IPI appears to have greater efficacy than either agent alone, regardless of PD-L1 expression or BRAF mutation status.

Median PFS (95% CI)
ITT population
11.5 (8.9–16.7)
6.9 (4.3–9.5)
2.9 (2.8–3.4)
0.76 (0.60–0.92)a
PD-L1 expression
NR (9.7–NR)
22.0 (8.9–NR)
3.9 (2.8–4.2)
0.87 (0.54–1.41)a
less than5%
11.1 (8.0–22.2)
5.3 (2.8–7.1)
2.8 (2.8–3.1)
0.74 (0.58–0.96)a

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