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Activity Number: 178
Type: Contributed
Date/Time: Monday, August 1, 2016 : 10:30 AM to 12:20 PM
Sponsor: Biopharmaceutical Section
Abstract #321518 View Presentation
Title: Efficacy Outcomes in Elderly Patients Treated with Pembrolizumab and Nivolumab
Author(s): Huanyu Chen* and Harpreet Singh and Sirisha Mushti and Kun He and Rajeshwari Sridhara
Companies: FDA and FDA and FDA and FDA and FDA
Keywords: Meta-analysis ; Geriatrics ; Immunotherapy ; Overall Survival
Abstract:

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. The concept of weakening of the immune system with age, warrants investigation.

To evaluate the efficacy outcomes in the geriatrics population receiving the immunotherapy, we retrospectively pooled 2,093 patients from four randomized Phase III clinical trials that were submitted in support of FDA's approval for pembrolizumab and nivolumab for the indications of metastatic melanoma, lung cancer, and advanced renal cell carcinoma. Forest plot, Begg's funnel plot, and Egger' test were performed in the Meta-analysis. The combined hazard ratios (HR) and respective 95% confidence intervals (95% CIs) in different age subgroups by drugs, trials, indications were calculated with respect to overall survival (OS).

The median age was 62 years (range 15-89) with 33%, 17%, 7%, and 2% of patients >= 65, 70, 75, and 80 years of age respectively. This exploratory meta-analysis shows improvement in OS for patients 65 years or older, 65-75 years, or 75 years or older.


Authors who are presenting talks have a * after their name.

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