Merck (MRK) Announces New KEYTRUDA Data to be Presented at SITC 2016 Annual Meeting

November 7, 2016 7:07 AM EST

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Merck (NYSE: MRK) announced that new data investigating the use of KEYTRUDA® (pembrolizumab), the company’s anti-PD-1 therapy, in patients with previously treated advanced urothelial cancer will be presented at the Society for Immunotherapy of Cancer’s (SITC) 31st Annual Meeting, Nov. 9-13. Data on overall survival (OS) and progression-free survival (PFS) from the phase 3 KEYNOTE-045 study – investigating KEYTRUDA compared to investigator’s choice chemotherapy in patients with metastatic or locally advanced or unresectable urothelial cancer that has recurred or progressed following platinum-based chemotherapy – will be presented for the first time; these data were accepted as a late-breaking abstract. In addition, results from three different studies exploring the utility of various biomarkers for KEYTRUDA will be presented at the meeting.

KEYTRUDA Data at SITC 2016

Below is a select listing of the KEYTRUDA abstracts accepted at SITC 2016; abstracts are available on the meeting website.

Late-Breaking Oral Presentation, Location: Maryland Ballroom

  • (Abstract #470) KEYNOTE-045: open-label, phase 3 study of pembrolizumab versus investigator’s choice of paclitaxel, docetaxel, or vinflunine for previously treated advanced urothelial cancer.Session Time: Saturday, Nov. 12, 11:15 a.m. – 12:00 p.m. ETPresentation Time: 11:45 a.m. – 12:00 p.m. ET

Poster Presentations, Location: Prince George's Exhibition Hall AB

  • (Abstract #61) Association between microsatellite instability and clinical response across tumor types in the phase 1b KEYNOTE-012 and KEYNOTE-028 studies of pembrolizumab in PD-L1-expressing advanced solid tumors.Session Time: Friday, Nov. 11, 12:15 p.m. – 1:30 p.m. ET
  • (Abstract #72) An immune-related gene expression profile delineates features of the tumor microenvironment required for clinical response to PD-1 blockade.Session Time: Saturday, Nov. 12, 11:45 a.m. – 1:00 p.m. ET
  • (Abstract #73) Tumor mutational load and T cell inflamed microenvironment are independent determinants of response to pembrolizumab.Session Time: Friday, Nov. 11, 12:15 p.m. – 1:30 p.m. ET

The KEYTRUDA (pembrolizumab) clinical development program includes more than 30 tumor types in more than 360 clinical trials, including nearly 200 trials that combine KEYTRUDA with other cancer treatments. For genitourinary cancers, Merck has the largest immuno-oncology clinical development program in bladder cancer, with 27 trials underway involving KEYTRUDA as monotherapy and in combination, including four registration-enabling studies.



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