MK 3475 success in study for Non Small Cell Lung Cancer - Merck Inc.,

Merck announced the first presentation of data evaluating pembrolizumab (MK-3475), Merck�s investigational anti-PD-1 antibody, as initial therapy in patients with PD-L1 positive, advanced Non-Small Cell Lung Cancer (NSCLC). In previously-untreated patients, the objective response rate (ORR) (confirmed and unconfirmed) with pembrolizumab as a single-agent (monotherapy) was 47 percent by investigator-assessed, immune-related response criteria (irRC) (n=21/45: 95% CI, 32-62) and 26 percent by centrally evaluated RECIST v1.1 (Response Evaluation Criteria in Solid Tumors) (n=11/42: 95% CI, 14-42). In evaluable patients who had measurable disease with one post baseline scan, 80 percent demonstrated tumor shrinkage as measured by centrally evaluated RECIST criteria (n=28/35). The median duration of response has not been reached, with some patients continuing on treatment with pembrolizumab as monotherapy for at least one year. These new data, from the company�s large ongoing Phase 1b study (KEYNOTE-001), were presented in an oral session by Dr. Naiyer Rizvi, medical oncologist, Thoracic Oncology Service, Memorial Sloan Kettering Cancer Center, at the 50th Annual Meeting of the American Society of Clinical Oncology (ASCO 2014) in Chicago (Abstract #8007).

Based on these data, Merck has enrolled 50 additional patients in the KEYNOTE-001 study with previously-untreated, advanced NSCLC with PD-L1 positive-staining tumours. For this cohort, cut points of greater than or equal to one percent and 50 percent tumor cells stained will be evaluated as part of the efficacy analysis. Additionally, Merck plans to initiate a Phase III study (KEYNOTE-024) evaluating pembrolizumab monotherapy versus platinum-based doublet chemotherapy (cisplatin, carboplatin combined with either: docetaxel, paclitaxel, vinorelbine, gemcitabine or irinotecan) in previously-untreated patients with PD-L1 positive, advanced NSCLC in September 2014.