Expanded access program for BMS anti- PD1 (nivolumab) for Stage III/IV melanoma!!!!

OK...BMS can't let the competition get ahead (aka...the EAP for the Merck 3475)!!!  BMS is technically ahead in the anti-PD1 race to FDA approval in that they have more patients in Phase II studies.  However, it is clear that they felt the pressure when MERCK "opened" their expanded access program.  You can find some data that shows an ever so slightly greater response rate with Merck than with BMS...but the powers that be....to whom I have spoken...seem to think that they are going to pan out at about the same, with approximately 30% of melanoma patients attaining either a complete or partial response.

Here's the deal:

Expanded access program with Nivolumab for subjects with histologically confirmed Stage III (unresectable) or Stage IV  advanced melanoma progressing post prior systemic treatment containing an anti_CTLA-4 monoclonal antibody.

NCT02142218        Sponsor:  Bristol-Myers Squibb        Date received:  May 16, 2014

Eligibility:

• 18 years of age or more
• Histologically confirmed malignant melanoma, including mucosal
• Previously treated unresectable med stage III or stage IV
• Progressed on or after prior treatment with an anti-CTLA4 containing therapy and, for subjects with known BRAF mutation, also progressed on or after treatment with a BRAF inhibitor

Exclusion Criteria:

• Active brain mets or leptomeningeal mets
• Life expectancy less than 6 weeks
• Subjects with active, known or suspected autoimmune disease
• Subjects with known history of anti-CTLA4 therapy related adverse reactions
• Any treatment in a Nivolumab clinical trial 

My Thoughts:

• Pretty much the same inclusions and restrictions as the Merck EAP....you must have failed ipi already and if you are BRAF positive, BRAF inhibitors as well.
• This EAP does state specifically that mucosal melanoma is allowed...the Merck EAP doesn't say one way or another.
• The Merck EAP has been frustratingly slow in its rollout...with its posting to ClinicalTrials.gov March 7 and actually treating the first patients at Mayo clinics just a little over 1 week ago...though things are starting to move at other facilities this week.
• Hopefully, the BMS EAP will get things moving a little more quickly.
• My fear:  Since both the Merck and BMS EAP are requiring failure of ipi and BRAFi when the patient is positive, I fear that these requirements may be included in the final FDA approval.  I don't KNOW that....it is just what I am worried about and would view that requirement as a waste of time, money and effort for patients.  If anti-PD1 is more effective for more patients....wouldn't it make sense to use that first...knowing that ipi and BRAFi could be used later if needed????  But....maybe that will not be what happens.

Wishing you all my best! - c