FDA subset analysis of the safety of nivolumab in elderly patients with advanced cancers.

10010 Background: With recent FDA approvals of immune checkpoint inhibitors for the treatment of advanced cancer, an increasing number of elderly patients will be treated with immunotherapy. Nivolumab is an immune checkpoint inhibitor, currently approved for the treatment of advanced renal cell cancer, melanoma, and non-small cell lung cancer based on significant responses including benefit in overall survival. However, little is known about the safety of nivolumab in an elderly patient population. Methods: Eligible patients recieved at least one dose of nivolumab as a single agent while enrolled in a phase 3 registration trial for the treatment of advanced renal cell cancer (CA209025), melanoma (CA209066), or non-small lung cancer (CA209057 and CA209017). Adverse events which occurred up to 100 days after last dose of nivolumab based on standardized adverse event datasets submitted by the sponsor were included. Results: See table. Conclusions: Immune therapies can benefit patients across a wide range of tumors. Currently there is little known about the safety of nivolumab in elderly patients. This exploratory analysis suggests that nivolumab is well tolerated in the elderly population in terms of adverse events. These data should be validated in larger patient cohorts, with specifically targeted age ranges to reflect the aging cancer population. The inclusion of greater numbers of elderly patients in registration clinical trials will further inform clinicians on the safety of immune based therapies in the elderly. Adverse events by age in patients treated with nivolumab. Patients < 65 yrs (N=616) n% Patients ≥ 65 yrs (N=414) n% Patients ≥ 70 yrs (N=212) n% Grade 1-2 Adverse Events 584 (94.8) 394 (95.2) 202 (95.3) Grade 3-5 Adverse Events 360 (58.4) 259 (62.6) 152 (71.7) Serious Adverse Events 313 (50.8) 242 (58.5) 123 (58.0) All Adverse Events leading to Discontinuation 89 (14.4) 71 (17.1 42 (19.8) AEs Requiring Treatment with Immune Modulating Medication 256 (41.5) 196 (47.3) 110 (51.9) Select irAE's where immune modulating medication was initiated Diarrhea/colitis 15 (2.4) 17 (4.1) 11 (5.2) Pneumonitis 23 (3.7) 8 (1.9) 5 (2.4) Hepatitis 8 (1.3) 3 (0.7) 1 (0.5) Nephritis and renal dysfunction 6 (1.0) 8 (1.9) 7 (3.3) Rash 47 (7.6) 34 (8.2) 22 (10.4)