ASCO 2015: Adverse effects from Nivo and how they are associated with survival

Nivolumab in resected and unresectable melanoma:  Immune-related adverse events and association with survival outcomes.  J Clin Oncol 33, 2015.  Freeman-Keller, Weber, et al.

Data was pooled and analyzed from 148 patients with resected (n=33) and unresectable (n=115) melanoma from Moffitt, given 1-, 3-, or 10mg/kg doses (with or without peptide vaccine) every 2 weeks for 12 wks, then every 12 weeks, up to 2 additional years if stable or better.  AE's of any level were found in 68% of patients.  Grade III/IV AE's were infrequent:  3 had a grade III rash, 2 had asymptomatic grade III amylase/lipase elevation, and 2 had grade III colitis.  Statistically significant progression free survival and overall survival differences were seen in patients who experienced any grade of AE.  Improved progression free survival was associated with rash and vitiligo.  Rash was associated with improved overall survival, with a non-significant association between vitiligo and overall survival.  No survival differences were seen with other AE's (endocrinopathies, diarrhea, or pneumonitis.)

Safety profile in nivolumab in patients with advanced melanoma:  A pooled analysis.  J Clin Oncol 33, 2015.  Weber, Antonia, Topalian, Schandendorf, Sznol, et al.

Retrospective safety review was conducted for 4 ongoing phase I-III trials in which melanoma patients were given nivo 3 mg/kg every 2 wks until disease progression or AE's.  576 patients were given nivo for median of 3.7 months.  312 had had prior ipi.  Most frequent AE's of any grade were:  fatigue (25%), itching (34%), GI problems (13%), endocrine (8%), and liver (4%).  Grade 3/4 AE's occurred in 4% of patients.  Median time of onset to AE's ranged from 5 wks for skin and 15 wks for renal.  Conclusion:  Drug related AE's to nivo were primarily low grade and the incidence of grade 3/4 drug related AE's was not affected by prior ipi.  Nearly all grade 3/4 AE's resolved with steroids which did NOT appear to impact on tumor response.

Wishing you much itching and a whiter shade of pale, my friends.  My goodness!  Itch away my fellow ratties, itch away!!  Still dealing with my 2 benadryl a day habit.  Guess that's a good thing. - c