Friday, July 11, 2014
Expanded Access for ipi/Nivo combo and Nivo/Opdivo Licensing Application????
Yesterday was a big day for BMS. We learned that Opdivo, the anti-PD1 product we know as Nivolumab, was approved in Japan.
BMS opened an expanded access program for the IPI and Nivo combo for Stage IV or unresectable Stage III melanoma patients. No locations are known as yet...typical for these EAP's. Mucosal melanoma and melanoma patients with treated brain mets that have been stable via MRI for 2 weeks before start of therapy ARE allowed. (That's a big improvement over the usual 8 week stability requirement!) However, patients must be ipi and Nivo naive and never have been even in the control arm of a trial with same. (This I find RIDICULOUS!!!) "Prior systemic therapy is permitted if it was completed at least 4 weeks prior to first dose..." (Which means that prior treatment with IL2, interferon, BRAFi, etc. ARE allowed, but not required.) No ocular melanoma. No autoimmune disease. No patient requiring steroids within 14 days prior to treatment. No HIV, Hep B, or Hep C. Scuttlebutt says that because ipi is an approved drug patients will have to provide payment for that, via insurance or some source, but the Nivo will be "free"! Hmmmm.... Bet that leaves a lot of wiggle room for all sorts of administration fees and hospital charges. Oh well....at least it will provide more options for many.
Here's the link: ipi and nivo combo expanded access at clinicaltrials.gov
Here's the data from the combo per Weber in his chat with Ribas after the ASCO presentations in June of this year:
"Ipi-Nivo Combo - ...highlight was...the abstract...presented by Sznol...an update of the concurrent ipi/nivo study in 2013...response rate about 45% in an updated expanded cohort of those with nivo at 1mg/kg and ipi at 3mg/kg...for as long as 96 weeks. The response rate was in the mid-40% range, but of greater importance, the 2-year survival was in the high-70% range..an important landmark in melanoma. ....must be balanced against a 62% rate of grade 3/4 immune-related adverse events, many of which were easily reversible...only about half required an interruption of treatment...Whenever the rate of side effects at grade 3/4 exceeds the response rate, you have to sit up and take notice. Nonetheless, a 70% plus survival rate at 2 years is outstanding in melanoma."
Link to synopsis of the original article from June 2013: Ipi and nivolumab, better together???
BMS is planning "a third quarter submission of a Biologics Licensing Application for Opdivo (Nivolumab) for previously treated advanced melanoma." Stipulations seem to include patients with unresectable or metastatic melanoma who have been previously treated with ipi and, if BRAF positive, with a BRAF inhibitor. Though none of that is absolute at this point. See article:
BMS submission of Biologics License for Nivo
Sadly, if these are the requirements....they echo my fears from May when BMS first announced their Expanded Access Program for Nivolumab along with those requirements:
EAP for BMS anti-PD1
Big day for BMS. I hope sites and provision of meds for real patients in need happens soon! They deserve a big day too!!
ONO4538 ~ MDX1106 ~ BMS936550 ~ Nivolumab ~ Opdivo???? Seriously?? OMG! 867-5309!!! LOL! WTF is wrong with you people!?????
Hang in there, peeps! It's gonna be a bumpy ride! - c
PS Anybody get my joke??? Hee hee hee! I crack myself up!!! ;>)
I think there's something wrong with my brain!