Thursday, September 28, 2017

Ooops! Opdivo (Nivolumab), did it again...this time it's approved for Liver Cancer

To back up a's some history, Opdivo style:

2014 - Opdivo (previously known as ONO4538, then MDX1106 [as it was called when I first started taking it], then BMS936558, then Nivolumab, and finally...Opdivo...dun, da, da dun!!!!) was approved for advanced melanoma patients after they had failed ipi and, if BRAF positive, BRAFi as well.
2015 - Opdivo was approved as a first line drug for unresectable or advanced melanoma, had to be BRAF positive - though there was an abundance of data demonstrating that BRAF status made no difference!!!
2015 - also saw Opdivo approved for use in advanced renal cell carcinoma as well as non-squamous and non-small cell lung cancer, after platinum based chemo.
2016 - FINALLY,  Opdivo was approved for use alone or with ipi, in advanced melanoma patients, no matter BRAF status.


Bristol-Myers Squibb’s Opdivo® (nivolumab) Receives FDA Approval for the Treatment of Hepatocellular Carcinoma Patients Previously Treated with Sorafenib

That's all great news.  The more help provided to cancer peeps the better!!  NOW!!! How bout seeking approval for folks with Stage III melanoma, hmmmmmm???  I think we ratties have more than provided the needed data....with this research pretty much saying it all:  Nivo better than ipi as adjuvant treatment for melanoma! Surprise, surprise, surprise!!! 

Check out the it is in a nutshell:

Stage IIIB, C, or Stage IV melanoma patients were allowed...even those with brain long as all were completely resected.

Patients joined from March 2015 to November 2015

There was a 5% cutoff for PD-L-1 staining (ie positive for PD-L-1 staining on tumors)

Nivo was given at 3mg/kg every 2 weeks or ipi was given at 10/mg/kg every 3 weeks for 4 doses then every 12 weeks.  Either drug was given for one year.

Patients were assessed via CT's of body and MRI of the brain every 12 weeks for 2 years, then every 6 months until year 5.

905 patients were studied, none of whom were still getting the drug by the final report.
Only 397 of these patients completed the full year of drug treatment.
Of the 452 in the nivo arm, 275 completed the year.  Of the 453 in the ipi arm, 122 completed.

Nivo outcomes were better than ipi no matter the patient's age, sex, disease stage, or BRAF status.  Nivo had fewer side effects.

In prior studies, ipi has demonstrated a pretty consistent 60% recurrence free survival in Stage III NED patients when used as adjuvant.  That number held in this study even when Stage IV patients were included.

Recurrence free survival at 12 months:
70.5% for nivo                    60.8% for ipi

Recurrence free survival at 18 months:
66.4% for nivo                    52.7% for ipi

Median distant metastasis free survival was not reached in either group.  However, it was longer in the nivo group with mets developing in 93 of the 369 peeps in the nivo group and in 115 of the 366 ipi group.

OVERALL recurrence free survival was 70.5% for the nivo group (vs 60.8% for ipi) at 1 year...but...when you pull out the Stage IV folks the number was 63% for nivo vs only 57% for ipi.

Call it by any name you like, BMS!  Let's get THIS approval DONE!!! - c

1 comment:

  1. Amen! If they approve Nivo for adjuvant for us non-BRAF ratties; I will roll with it. I've resisted Yervo because it seems too toxic for the benefit.