Anti-PD1/vaccine report at ASCO (my sister study)

The American Society of Clinical Oncology (ASCO) will be holding its annual meeting the first week of June in Chicago.  However, some of the abstracts have already been released (and gone over with a fine tooth comb by the Brentster!!).  What follows is my synopsis of the abstract, released by Kudchadkar, Gallenstein, Martinez, Yu, and Weber...out of Moffitt Cancer Center in Tampa, FL.

(Basically, these are the results thus far on my sister study, the 30 matching patients taking my same vaccines, MDX 1106 at 1, 3, and 10mg/kg on the same schedule....except they are all stage IV melanoma, NON-resected.  Folks in my position, going into the study with no evidence of disease, are more difficult to utilize in determining effect and outcomes.  Sadly, while I feel this is the time to strike the disease, because of this difficulty, few trials are offered to stage IV NED folks...in fact, I know of no new ones at this time.)

"30, HLA A*0201 positive patients [required due to the vaccine component] with unresectable, previously treated melanoma, received MART-1gp100/NY-ESO-1 peptides with adjuvant Montanide ISA 51 injected subcutaneously with BMS-936558 [The same as MDX 1106, so named when company managing product was Mederex. The name changed to the BMS blah blah when Bristol-Myers took over!] at 1, 3, and 10 mg/kg IV every 2 weeks for 24 weeks, followed by BMS-936558 alone every 3 months. No patient had prior [ipi]....RESULTS: Median age = 63, 14 men, 16 women. 73% had M1c disease. [There are 3 categories of metastatic disease. a = distant skin mets, normal LDH. b = lung. c = other distant mets, or any of the above with elevated LDH.] One patient had dose limiting optic neuritis; one had dose limiting grade 3 interstitial pneumonitis. Of 10 patients at 1mg/kg: 2 had confirmed partial responses (PR), both one year from initiation of study. Of 13 patients at 3 mg/kg: 3 patients did not complete more than 3 doses [due] to progressive disease and one withdrew consent. Of 12 evaluable patients: 3 had confirmed PR's and 2 unconfirmed PR's. In the 10 mg/kg group:  6 patients have completed one cycle with 2 unconfirmed PR's and one patient is stable.  Only 2 of the 9 responders after one cycle have progressed with median follow-up of 7 months. 2/6 failing BMS-936558 responded to [ipi].  CONCLUSION:  BMS-936558 in combination with a peptide vaccine is well tolerated at 1 and 3 mg/kg.  Accrual to 10 mg/kg is..ongoing. Responses have been observed at all levels.  Further study warranted...to determine optimal dose."

SO...there you have it.  Please check out the ASCO abstracts for yourself! - c