KENILWORTH, N.J.--(BUSINESS WIRE)--
Merck (MRK), known as MSD outside the United States and Canada, today announced that extensive data on KEYTRUDA® (pembrolizumab), the company’s anti-PD-1 therapy, have been accepted for presentation at the European Society for Medical Oncology (ESMO) 2016 Congress in Copenhagen, Denmark, Oct. 7 – 11. In total, findings from 30 studies in 12 cancers from Merck’s industry-leading clinical development program for KEYTRUDA – both as monotherapy and in combination – will be presented at this year’s ESMO. Two studies of KEYTRUDA in first-line treatment of advanced lung cancer have also been selected for presentation at the Presidential Symposium on Oct. 9: KEYNOTE-024, which studied KEYTRUDA as monotherapy compared to chemotherapy in patients whose tumors express high levels of PD-L1 (tumor proportion score of 50 percent or more), and KEYNOTE-021G, which studied KEYTRUDA plus chemotherapy (carboplatin and pemetrexed) compared to chemotherapy alone in all patients with non-squamous non-small cell lung cancer (NSCLC).
KEYTRUDA-Related Data at the ESMO 2016 Congress
A select listing of the KEYTRUDA late-breaking and oral abstract sessions at ESMO 2016 is included below:
Advanced Non-Small Cell Lung Cancer (NSCLC)
At ESMO, in addition to KEYNOTE-024 and KEYNOTE-021G, which studied KEYTRUDA (pembrolizumab) in previously untreated patients whose tumors were EGFR- and ALK-negative, updated overall survival (OS) data from the phase 2/3 KEYNOTE-010 trial will be presented; KEYNOTE-010 studied previously treated patients with advanced NSCLC whose tumors express PD-L1 (tumor proportion score of one percent or more).
Additional combination data will also be presented from the phase 1b KEYNOTE-098 expansion cohort study investigating KEYTRUDA in combination with the VEGF Receptor 2 antagonist, ramucirumab (under the existing collaboration between Eli Lilly and Company and Merck).
(Abstract #LBA46_PR) Presidential Symposium: Randomized, phase 2 study of carboplatin and pemetrexed with or without pembrolizumab as first-line therapy for advanced NSCLC: KEYNOTE-021 cohort G. C. Langer. Sunday, October 9, 4:25 – 6:20 pm CEST. Location: Copenhagen.
(Abstract #LBA8_PR) Presidential Symposium: KEYNOTE-024: Pembrolizumab (pembro) vs platinum-based chemotherapy (chemo) as first-line therapy for advanced NSCLC with a PD-L1 tumor proportion score (TPS) ≥ 50%. M. Reck. Sunday, October 9, 4:25 – 6:20 pm CEST. Location: Copenhagen.
(Abstract #LBA48) Poster Discussion Session: Pembrolizumab (pembro) vs docetaxel (doce) for previously treated, PD-L1–expressing NSCLC: updated outcomes of KEYNOTE-010. R. Herbst. Sunday, October 9, 2:45 – 4:15 pm CEST. Location: Oslo.
(Abstract #LBA38) Poster Discussion Session: Interim safety and clinical activity in patients with advanced NSCLC from a multi-cohort phase 1 study of ramucirumab (R) plus pembrolizumab (P). R. Herbst. Monday, October 10, 9:30 – 10:30 am CEST. Location: Berlin.
Advanced Bladder Cancer
At ESMO, data investigating the first-line use of KEYTRUDA in patients with unresectable or advanced urothelial (bladder) cancer will be presented from the phase 2 KEYNOTE-052 trial; results will be featured in the official ESMO press program. This is the first presentation of data investigating KEYTRUDA in the first-line bladder cancer treatment setting.
(Abstract #LBA32_PR) Proffered Paper Session: Pembrolizumab (pembro) as first-line therapy for advanced/unresectable or advanced urothelial cancer: Preliminary results from the phase 2 KEYNOTE-052 study. A. Balar. Saturday, October 8, 9:15 – 10:30 am CEST. Location: Madrid.
At ESMO, final OS data from the phase 2 KEYNOTE-002 trial investigating
KEYTRUDA (pembrolizumab) monotherapy compared to chemotherapy in patients with ipilimumab-refractory advanced melanoma will be presented.
(Abstract #1107O) Proffered Paper Session: Final overall survival for KEYNOTE-002: pembrolizumab (pembro) versus investigator-choice chemotherapy (chemo) for ipilimumab (ipi)-refractory melanoma. O. Hamid. Saturday, October 8, 2:45 – 4:15 pm CEST. Location: Copenhagen.
Additional Data from Merck’s Oncology Portfolio and Pipeline
Data investigating the use of two compounds from Merck’s oncology pipeline and portfolio – EMEND® (fosaprepitant dimeglumine), a substance P/neurokinin-1 (NK1) receptor antagonist, and MK-2206, an investigational AKT inhibitor – were also accepted for presentation at this year’s ESMO. For more information, including a complete list of abstract titles, please visit the ESMO website at https://cslide.ctimeetingtech.com/library/esmo/browse/itinerary/5286.
About KEYTRUDA® (pembrolizumab)
KEYTRUDA is a humanized monoclonal antibody that works by increasing the ability of the body’s immune system to help detect and fight tumor cells. KEYTRUDA blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2, thereby activating T lymphocytes which may affect both tumor cells and healthy cells.
KEYTRUDA is administered as an intravenous infusion over 30 minutes every three weeks for the approved indications. KEYTRUDA for injection is supplied in a 100 mg single use vial.
KEYTRUDA Indications and Dosing
KEYTRUDA is indicated for the treatment of patients with unresectable or metastatic melanoma at a dose of 2 mg/kg every three weeks.
KEYTRUDA (pembrolizumab) is indicated for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors express PD-L1 as determined by an FDA-approved test with disease progression on or after platinum-containing chemotherapy, at a dose of 2 mg/kg every three weeks. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving KEYTRUDA. This indication is approved under accelerated approval based on tumor response rate and durability of response. An improvement in survival or disease-related symptoms has not yet been established. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.
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Last updated on: 29/09/2016
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