Keynote 001 study pdf

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. Treatment of advanced nonsmall cell lung cancer nsclc. An adaptive study leading to accelerated approval for two indications and a companion diagnostic find, read and. Keynote 001 is an ongoing multicenter, singlearm, openlabel phase 1b study evaluating keytruda in more than 1,000 patients with diverse. This is an open access article under the ccbync license. Breakthrough 5year survival with pembrolizumab in keynote 001 study. Antitumour activity of pembrolizumab in advanced mucosal. Study of pembrolizumab mk3475 in participants with progressive. Pembrolizumab in patients with advanced nonsmallcell. Kang and others published pembrolizumab keynote001. There were 550 patients with advanced nsclc in the trial, including 101 patients who were treatmentnaive and 449 patients who had. Published by oxford university press on behalf of the european society for medical oncology. 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.

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. Fiveyear survival outcomes for patients with advanced melanoma. Preclinical studies suggesting that pembrolizumab had antitumor properties in multiple cancers 38x 38. 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. Study of pembrolizumab mk3475 in participants with. Fiveyear overall survival for patients with advanced non.

Pembrolizumab versus docetaxel for previously treated, pd. Pembrolizumab for the treatment of nonsmallcell lung. Keynote042 confirms firstline pembrolizumab superior to. Keynote 001 was an openlabel, multicohort, phase 1b study of pembrolizumab 2 mgkg q3w, 10 mgkg q3w, or 10 mgkg q2w in adults with ipilimumabpd1.

However, it was unlike other firstinhuman studies because it enrolled over patients and. Study participants had no targetable alterations and a pdl1 tps greater than or equal to 50% in keynote 024, but in keynote 042 clinicaltrials. Subsequent phase iii studies of nivolumab as monotherapy in. 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. 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. According to the trial researchers, keynote001 is the longest followup study to date of people with advanced nsclc treated with. Compared with analysis at 3 years, only three newonset. Preclinical studies suggesting that pembrolizumab had antitumor properties in multiple cancers 38, 39 led to initiation of the phase 1 keynote. Keynote587 nct03486873, which would allow further study participation.

Full details of the study design with amendments for the nsclc cohorts of keynote 001 have been reported previously. Breakthrough 5year survival with pembrolizumab in keynote. An adaptive study leading to accelerated approval for. This 5year analysis of keynote001 represents the longest followup for pembrolizumab to. Carcinoma, melanoma, and nonsmall cell lung carcinoma keynote 001. Pembrolizumab for the treatment of nonsmallcell lung cancer. We report 5year outcomes from the phase ib keynote001 study. The keynote 001 study was the original study of pembrolizumab, according to garon.