European Commission Approves Merck & Eisai’s Keytruda + Lenvima as First Immuno-Oncology Plus Tyrosine Kinase Inhibitor Combination for Advanced Endometrial Carcinoma, Demonstrating Significant Survival Benefit
Dec 13, 2021 00:58
CST Updated
00:58
MSD
Pharmaceutical R&D and Manufacturer
Eisai
Pharmaceutical Product R&D and Manufacturer
European Commission
The European Commission, abbreviated as the EU Commission, is a supranational body under the European Union. Within the EU political system, the European Commission primarily undertakes executive tasks, thus being roughly equivalent to the government in a national system. However, the European Commission has other functions as well. In particular, except for the few circumstances specified in the treaties, the European Commission is the only institution with legislative power in the EU legislative process.
Endometrial Cancer (Image Source: womenworking.com)
December 12, 2021 /BioValleyBIOON/ -- MSD (Merck & Co) and its partner Eisai recently announced jointly that the European Commission (EC) has approved the combination of anti-PD-1 therapy Keytruda (generic name: pembrolizumab) and oral multi-receptor tyrosine kinase inhibitor Lenvima (European trade name: Kisplyx, generic name: lenvatinib) for the treatment of adult patients with advanced or recurrent endometrial cancer (EC) who have progressed following prior treatment with a platinum-containing regimen in any setting and are not candidates for curative surgery or radiation.
It is worth mentioning that,Keytruda+Lenvima is the first immunotherapy plus tyrosine kinase inhibitor combination regimen approved in Europe for the aforementioned patient population with advanced or recurrent EC.In the United States, the Keytruda + Lenvima regimen was approved in July 2021 for the treatment of patients with advanced endometrial cancer (EC) whose disease has progressed following prior systemic therapy in any setting, are not candidates for curative surgery or radiation, and have been tested and confirmed not to be microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR). Here, "not MSI-H or not dMMR" is also referred to as "non-microsatellite instability-high (non-MSI-H) or mismatch repair proficient (pMMR)."
Keytruda+Lenvima is an "immunotherapy + targeted therapy" combination regimen. To date, it has been approved in the United States and the European Union for the treatment of two different types of cancer. Another indication is: first-line treatment of adult patients with advanced renal cell carcinoma (RCC).
This approval was based on data from the pivotal Phase 3 KEYNOTE-775/Study 309 trial (NCT03517449). The trial evaluated the efficacy and safety of the Keytruda + Lenvima regimen in patients with advanced, metastatic, or recurrent endometrial cancer whose disease had progressed after receiving platinum-based chemotherapy.
The results showed,Compared with chemotherapy (investigator's choice: doxorubicin or paclitaxel), the Keytruda + Lenvima regimen showed statistically significant and clinically meaningful improvements in the primary endpoints of overall survival (OS) and progression-free survival (PFS), as well as the secondary endpoint of overall response rate (ORR).(1) The risk of death was reduced by 38% (HR=0.62 [95% CI: 0.51-0.75]; p<0.0001), with a significant extension of OS (median: 18.3 months vs 11.4 months); (2) The risk of disease progression or death was reduced by 44% (HR=0.56 [95% CI: 0.47-0.66]; p<0.0001), with a significant extension of PFS (median: 7.2 months vs 3.8 months); (3) ORR was significantly improved (32% vs 15%; p<0.0001). In the Keytruda + Lenvima group, the complete response rate (CR) was 7% and the partial response rate (PR) was 25%, while in the chemotherapy group, CR was 3% and PR was 12%.
The safety of the Keytruda + Lenvima regimen was evaluated in 530 patients with advanced EC. The most commonAdverse ReactionsForHypertension(63%), diarrhea (57%), hypothyroidism (56%), nausea (51%), decreased appetite (47%), vomiting (39%), fatigue (38%), weight loss (35%), arthralgia (33%), proteinuria (29%), constipation, headache, and urinary tract infection (each 27%), dysarthria (25%), abdominal pain, asthenia, palmar-plantar erythrodysesthesia syndrome, and stomatitis (each 23%),Anemia(22%) and hypomagnesemia (20%).
The combination therapy of Keytruda + Lenvima is part of the oncology strategic collaboration between MSD and Eisai. In March 2018, the two parties signed a cooperation agreement totaling up to 5.8 billion US dollars to develop Lenvima as a monotherapy and in combination with Keytruda for various types.TumorTreatment.
Keytruda is an anti-PD-1 tumor immunotherapy that helps detect and combat tumor cells by enhancing the ability of the human immune system. Keytruda is a humanized monoclonal antibody that blocks the interaction between PD-1 and its ligands PD-L1 and PD-L2, thereby activating potentially impactfulTumorT lymphocytes of cells and healthy cells.
Lenvima is an orally administered multi-receptor tyrosine kinase (RTK) inhibitor with a novel binding mode, inhibiting not only factors involved in tumor angiogenesis and tumor progression but also...TumorIn addition to other pro-angiogenic and oncogenic signaling pathways related to immune-modified RTKs (including platelet-derived growth factor (PDGF) receptors PDGFRα, KIT, and RET), it can selectively inhibit the kinase activity of vascular endothelial growth factor (VEGF) receptors (VEGFR1, VEGFR2, VEGFR3) and fibroblast growth factor (FGF) receptors (FGFR1, FGFR2, FGFR3, FGFR4).
Currently, MSD and Eisai are conducting the LEAP (LEnvatinib And Pembrolizumab) clinical development program across more than 10 different types of tumors (endometrial cancer, hepatocellular carcinoma,Melanoma, Non-Small Cell Lung Cancer, Renal Cell Carcinoma, Squamous Cell Carcinoma of the Head and Neck, Urothelial Carcinoma, Cholangiocarcinoma, Colorectal Cancer, Gastric Cancer, Glioblastoma, Ovarian Cancer, Pancreatic Cancer, and Triple-NegativeBreast Cancer) More than 20 itemsClinical TrialChina continues to study the Keytruda + Lenvima combination. Data from this program shows that the Keytruda + Lenvima combination has been used in various typesTumorDemonstrated strong efficacy. (Bioon.com)