Applications Based on Progression-Free Survival, Overall Survival, and Objective Response Rate Data From Respective Pivotal Phase 3 Trials Merck (NYSE: MRK), known as MSD outside the United States and Canada, and Eisai Inc. today announced that the U.S. Food and Drug Administration (FDA) has accepted and granted priority review for applications seeking two new approvals for the combination of KEYTRUDA, Merck’s anti-PD-1 therapy, plus LENVIMA, the orally available multiple receptor tyrosine kinase inhibitor discovered by Eisai. The first set of applications (a supplemental Biologics License Application [sBLA] for KEYTRUDA and a supplemental New Drug Application [sNDA] for LENVIMA) are for the first-line treatment of patients with advanced renal cell carcinoma (RCC), based on progression-free survival (PFS), overall survival (OS) and objective response rate (ORR) data from the pivotal Phase 3 CLEAR study (KEYNOTE-581/Study 307). The second set of applications are for the treatment of
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Recommendation Based on Data From Phase 3 KEYNOTE-355 Trial Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended approval of KEYTRUDA, Merck’s anti-PD-1 therapy, in combination with chemotherapy for the treatment of locally recurrent unresectable or metastatic triple-negative breast cancer (TNBC) in adults whose tumors express PD-L1 (Combined Positive Score [CPS] ≥10) and who have not received prior chemotherapy for metastatic disease. The positive opinion is based on progression-free survival (PFS) and overall survival (OS) results from the Phase 3 KEYNOTE-355 trial, which showed that treatment with KEYTRUDA in combination with chemotherapy (nab-paclitaxel, paclitaxel or gemcitabine/carboplatin), as compared to chemotherapy alone, significantly improved PFS and OS in these patients. Overall survival data from KEYNOTE-355 will be presented
KEYTRUDA Is the First Anti-PD-1 Therapy in Combination With Chemotherapy to Show Statistically Significant OS for This Patient Population Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced positive overall survival (OS) results from the pivotal Phase 3 KEYNOTE-355 trial evaluating KEYTRUDA, Merck’s anti-PD-1 therapy, in combination with chemotherapy for the treatment of patients with metastatic triple-negative breast cancer (mTNBC). Findings from the final analysis show first-line treatment with KEYTRUDA in combination with chemotherapy (nab-paclitaxel, paclitaxel or gemcitabine/carboplatin) demonstrated a statistically significant and clinically meaningful improvement in OS compared with chemotherapy alone in patients with mTNBC whose tumors expressed PD-L1 (Combined Positive Score [CPS] ≥10). No new safety signals were identified. These OS results will be presented at an upcoming medical meeting and submitted to regulatory authorities. “In the
LENVIMA Plus Everolimus Also Showed Statistically Significant Improvement in PFS and ORR Endpoints Versus Sunitinib Results of Investigational Phase 3 KEYNOTE-581/CLEAR Trial (Study 307) to be Presented at Upcoming Medical Meeting Merck (NYSE: MRK), known as MSD outside the United States and Canada, and Eisai today announced new investigational data demonstrating positive top-line results from the pivotal Phase 3 KEYNOTE-581/CLEAR trial (Study 307). In the trial, the combinations of KEYTRUDA, Merck’s anti-PD-1 therapy, plus LENVIMA, the orally available multiple receptor tyrosine kinase inhibitor discovered by Eisai, and LENVIMA plus everolimus were evaluated versus sunitinib for the first-line treatment of patients with advanced renal cell carcinoma (RCC). KEYTRUDA plus LENVIMA met the trial’s primary endpoint of progression-free survival (PFS) and its key secondary endpoints of overall survival (OS) and objective response rate (ORR), demonstrating a statistically significant
First Anti-PD-1 Therapy in Combination With Chemotherapy to Demonstrate Statistically Significant Overall Survival for These Patients Data From Phase 3 KEYNOTE-355 Trial Presented at ESMO Congress 2021 Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced the final overall survival (OS) results from the pivotal Phase 3 KEYNOTE-355 trial investigating KEYTRUDA, Merck’s anti-PD-1 therapy, in combination with chemotherapy (paclitaxel, nab-paclitaxel or gemcitabine/carboplatin) for the first-line treatment of patients with metastatic triple-negative breast cancer (mTNBC). KEYTRUDA is the first anti-PD-1 therapy in combination with chemotherapy to demonstrate a statistically significant and clinically meaningful improvement in OS for these patients. In this study, KEYTRUDA plus chemotherapy reduced the risk of death by 27% (HR=0.73 [95% CI, 0.55-0.95]; p=0.0093) in patients with mTNBC whose tumors expressed PD-L1 (Combined Positive Score [CPS] ≥10), as
New Results Include Findings From the Phase 2 LEAP-004 Trial Showing an ORR of 21.4% in Patients With Unresectable or Advanced Melanoma Who Had Previously Progressed on an Anti-PD-1/PD-L1 Therapy Merck (NYSE: MRK), known as MSD outside the United States and Canada, and Eisai today announced new investigational data from two trials under the LEAP (LEnvatinib And Pembrolizumab) clinical program evaluating KEYTRUDA, Merck’s anti-PD-1 therapy, plus LENVIMA, the orally available multiple receptor tyrosine kinase inhibitor discovered by Eisai. In the Phase 2 LEAP-004 trial, KEYTRUDA plus LENVIMA showed an objective response rate (ORR) of 21.4% (95% CI: 13.9-30.5) in patients with unresectable or advanced melanoma who had previously progressed on an anti-PD-1/PD-L1 therapy. In the Phase 2 LEAP-005 trial, KEYTRUDA plus LENVIMA demonstrated an ORR that ranged from 9.7-32.3% (95% CI: 2.0-51.4) in previously treated patients with triple-negative breast cancer (TNBC), ovarian cancer, gastric
First Overall Survival Analysis for KEYTRUDA Plus LENVIMA Combination in a Phase 3 Study in Advanced Endometrial Cancer Merck (NYSE: MRK), known as MSD outside the United States and Canada, and Eisai today announced that the pivotal Phase 3 KEYNOTE-775/Study 309 trial evaluating the investigational use of KEYTRUDA, Merck’s anti-PD-1 therapy, plus LENVIMA, the orally available multiple receptor tyrosine kinase inhibitor discovered by Eisai, met its dual primary endpoints of overall survival (OS) and progression-free survival (PFS) and its secondary efficacy endpoint of objective response rate (ORR) in patients with advanced endometrial cancer following at least one prior platinum-based regimen. These positive results were observed in the mismatch repair proficient (pMMR) subgroup and the intention-to-treat (ITT) study population, which includes both patients with endometrial carcinoma that is pMMR as well as patients whose disease is microsatellite instability-high (MSI-H)/mismatch
This KEYTRUDA Combination Is the First Immunotherapy Regimen Approved for High-Risk Early-Stage Triple-Negative Breast Cancer (TNBC) KEYTRUDA Is Now Approved in the US for 30 Indications Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has approved KEYTRUDA, Merck’s anti-PD-1 therapy, for the treatment of patients with high-risk early-stage triple-negative breast cancer (TNBC) in combination with chemotherapy as neoadjuvant treatment and then continued as a single agent as adjuvant treatment after surgery, based on the Phase 3 KEYNOTE-522 trial. TNBC is an aggressive type of breast cancer with an increased risk for disease recurrence. KEYNOTE-522 showed that KEYTRUDA in combination with chemotherapy (carboplatin and paclitaxel, followed by doxorubicin or epirubicin and cyclophosphamide) before surgery and continued as a single agent after surgery significantly prolonged event-free survival (EFS)
KEYTRUDA Plus LENVIMA Significantly Reduced Risk of Disease Progression or Death by 61% Versus Sunitinib, With a Median PFS of Nearly Two Years Versus Nine Months for Sunitinib LENVIMA Plus Everolimus Significantly Improved PFS and Objective Response Rate Versus Sunitinib First Results From Pivotal CLEAR Study (KEYNOTE-581/Study 307) Presented at 2021 Genitourinary Cancers Symposium (ASCO GU) and Published in the New England Journal of Medicine Merck (NYSE: MRK), known as MSD outside the United States and Canada, and Eisai today announced the first presentation of new investigational data from the pivotal Phase 3 CLEAR study (KEYNOTE-581/Study 307) in an oral presentation session (Abstract #269) at the virtual 2021 Genitourinary Cancers Symposium (ASCO GU) and simultaneously published in the New England Journal of Medicine . The trial evaluated the combinations of KEYTRUDA, Merck’s anti-PD-1 therapy, plus LENVIMA, the orally available multiple receptor tyrosine kinase inhibitor
Analyses from KEYTRUDA Plus LENVIMA Trials to be Presented at 2020 ASCO Annual Meeting Merck (NYSE: MRK), known as MSD outside the United States and Canada, and Eisai today announced new data from analyses of two trials evaluating KEYTRUDA, Merck’s anti-PD-1 therapy, plus LENVIMA, an orally available multiple receptor tyrosine kinase inhibitor discovered by Eisai. In the KEYNOTE-524/Study 116 and KEYNOTE-146/Study 111 trials, the KEYTRUDA plus LENVIMA combination demonstrated clinically meaningful objective response rates (ORR) in patients with unresectable hepatocellular carcinoma (HCC) with no prior systemic therapy and in patients with metastatic clear cell renal cell carcinoma (ccRCC) who progressed following immune checkpoint inhibitor therapy, respectively. “The tumor response rates demonstrated with KEYTRUDA plus LENVIMA in these studies underscore the potential of this combination regimen in certain types of hepatocellular and renal cell carcinoma,” said Dr. Jonathan Cheng,