Keynote 001 study pdf

We report 5year outcomes from the phase ib keynote001 study. Study of pembrolizumab mk3475 in participants with. Breakthrough 5year survival with pembrolizumab in keynote 001 study. Keynote587 nct03486873, which would allow further study participation. Carcinoma, melanoma, and nonsmall cell lung carcinoma keynote 001. Pembrolizumab journal for immunotherapy of cancer biomed.

Compared with analysis at 3 years, only three newonset. There were 550 patients with advanced nsclc in the trial, including 101 patients who were treatmentnaive and 449 patients who had. Treatment of advanced nonsmall cell lung cancer nsclc. Keynote 001 is a multicohort, openlabel, phase 1 study of pembrolizumab 2 mgkg every 3 weeks or 10 mgkg every 2 or 3 weeks in treatment naive or previously treated patients with locally advanced or metastatic nonsmallcell lung cancer with measurable disease at baseline. An adaptive study leading to accelerated approval for two indications and a companion diagnostic find, read and. Pembrolizumab for the treatment of nonsmallcell lung cancer. Fiveyear survival outcomes for patients with advanced melanoma.

Preclinical studies suggesting that pembrolizumab had antitumor properties in multiple cancers 38, 39 led to initiation of the phase 1 keynote. As part of the large, international, phase 1 keynote 001 trial, we evaluated the side effects, safety, and antitumor activity of pembrolizumab in patients with advanced nonsmallcell lung cancer. Phase i study of single agent pembrolizumab mk3475 in patients with progressive locally advanced or metastatic carcinoma, melanoma, and nonsmall cell lung carcinoma keynote 001 actual study start date. Kang and others published pembrolizumab keynote001. We also sought to define and validate an expression level of the pd1 ligand 1 pdl1 that is associated with the likelihood of clinical benefit. Full details of the study design with amendments for the nsclc cohorts of keynote 001 have been reported previously. Pembrolizumab for the treatment of nonsmallcell lung. Keynote042 confirms firstline pembrolizumab superior to. Keynote 042 is the first study with a primary endpoint of overall survival to demonstrate superiority of pembrolizumab over platinumbased chemotherapy in patient with previously untreated. The pembrolizumab keynote 001 study is an innovative and groundbreaking study that has led to multiple regulatory achievements, including orphan drug designation, breakthrough therapy designations, accelerated approvals for the treatment of melanoma and nsclc, and approval for a companion diagnostic for pdl1 tumor expression in nsclc. Pembrolizumab versus docetaxel for previously treated, pd. In 2011, when keynote 001 began enrollment, immunotherapy treatments were not widely available, so most participants had previously been treated with systemic medicines or targeted therapies. Subsequent phase iii studies of nivolumab as monotherapy in. Preclinical studies suggesting that pembrolizumab had antitumor properties in multiple cancers 38x 38.

Antitumour activity of pembrolizumab in advanced mucosal. Study participants had no targetable alterations and a pdl1 tps greater than or equal to 50% in keynote 024, but in keynote 042 clinicaltrials. Fiveyear overall survival for patients with advanced non. The keynote 001 study was the original study of pembrolizumab, according to garon. Chicago longterm study data confirm the durable antitumor activity associated with the antipd1 antibody pembrolizumab in patients with melanoma, according to study results presented at. According to the trial researchers, keynote001 is the longest followup study to date of people with advanced nsclc treated with.