Tuesday, March 5, 2019

KEYNOTE-001: Melanoma patients treated with Pembrolizumab (Keytruda) - 5 year survival outcomes

The KEYNOTE-001 study which administered Pembrolizumab (Keytruda) to melanoma patients with advanced disease and started back in 2011 has provided a great deal of data over the years.  Here are some of those reports:  KEYNOTE-001 reports over the years

Now there's this:

Five-year survival outcomes for patients with advanced melanoma treated with pembrolizumab in KEYNOTE-001.   Hamid, Robert, Daud, Hodi,…, Wolchok,…, Weber,…, Ribas.  Ann Oncol. 2019 Jan 31.

Pembrolizumab demonstrated robust antitumor activity and safety in the phase 1b KEYNOTE-001 study (NCT01295827) of advanced melanoma. Five-year outcomes in all patients and treatment-naive patients are reported herein. Patients whose disease progressed following initial response and who received a second course of pembrolizumab were also analyzed.

Patients aged greater than/= to 18 years with previously treated or treatment-naive advanced/metastatic melanoma received pembrolizumab 2 mg/kg every 3 weeks, 10 mg/kg every 3 weeks, or 10 mg/kg every 2 weeks until disease progression, intolerable toxicity, or patient/investigator decision to withdraw. Kaplan-Meier estimates of overall survival (OS) and progression-free survival (PFS) were calculated. Objective response rate and PFS were based on immune-related response criteria by investigator assessment (data cutoff, September 1, 2017).

KEYNOTE-001 enrolled 655 patients with melanoma; median follow-up was 55 months. Estimated 5-year OS was 34% in all patients and 41% in treatment-naive patients; median OS was 23.8 months and 38.6 months, respectively. Estimated 5-year PFS rates were 21% in all patients and 29% in treatment-naive patients; median PFS was 8.3 months and 16.9 months, respectively. Median response duration was not reached; 73% of all responses and 82% of treatment-naive responses were ongoing at data cutoff; the longest response was ongoing at 66 months. Four patients (all with prior response of complete response) whose disease progressed during observation subsequently received second-course pembrolizumab. One patient each achieved CR and partial response (after data cutoff). Treatment-related AEs (TRAEs) occurred in 86% of patients and resulted in study discontinuation in 7.8%; 17% experienced grade 3/4 TRAE.  This 5-year analysis of KEYNOTE-001 represents the longest follow-up for pembrolizumab to date and confirms the durable antitumor activity and tolerability of pembrolizumab in advanced melanoma.

Good news, especially back in 2011.  Good news regarding durability of response.  Good news regarding re-induction with a second course for those in need.  Still in need of treatments that garner a complete response in MORE melanoma peeps.  Thanks, ratties. - c

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