Tumor immunotherapy upgrade! Mercadon announces the first clinical results: Keytruda 6-week medication program, the efficacy is comparable to the 3-week program!

April 27, 2020 /pr.
bioON/ BioValley BIOON/ -- Merck and Co recently released medium-term data on the anti-PD-1 therapy Keytruda (Creeda, generic name: pembrolizumab, Pablo zumab, Pablo zumab) treatment for metastatic melanoma phase I KEYNOTE-555 study cohort B Data show that the efficacy and safety of the 400mg (400mg Q6W) administration regimen in Keytruda every 6 weeks is comparable to the currently approved 200mg (200mg Q3W) administration every 3 weeks interim data show that the total remission rate (ORR) for patients treated with Keytruda 400mg Q6W was 38.6% (n?17/44; 95% CI: 24.4-54.5) It is worth noting that these data represent the first clinical results to evaluate keytruda Q6W drug administration just recently, Mercado has returned to the U.S Food and Drug Administration (
The FDA ) filed a Supplemental Biologics Licensing Request (BLA) to update Keytruda's frequency of administration and include a 400mg Q6W option in all approved adult indications Currently, Keytruda's administration is 200 mg (200mg Q3W, intravenous infusions, at least 30 minutes) every 3 weeks If approved, the 400mg Q6W solution will provide patients with a more friendly treatment option, with reduced frequency of administration and greater treatment flexibility for patients and oncologists the results of the KEYNOTE-555 support the BLA submission In the EU, in March 2019, the European Commission approved the 400mg Q6W administration of Keytruda single-drug treatment for all approved single-drug treatment strains covering five types of tumor , including: non-small cell lung cancer (NSCLC), melanoma , bladder cancer, head and neck cancer, and classic Hodgkin's lymphoma "We remain committed to improving cancer treatment, including greater flexibility in Keytruda treatment," said Dr Scott Ebbinghau, vice president of clinical research at the 's Mercadon Research Laboratory These data, together with extensive model-based assessments, provide strong evidence for Keytruda Q6W drug regimens "
KEYNOTE-555 (NCT03665597) is a Phase I open label trial that is evaluating the relative bioavailability of patients with phase III or IV melanoma of Keytruda subcutaneous injection and intravenous treatment The main endpoints of the study were total mitigation rates (ORR), and secondary endpoints included pharmacokinetics (PK) exposure, progressionless survival (PFS), and safety in queue B, 100 patients were assigned to Keytruda 400mg Q6W The first 44 patients with sufficient follow-up data to assess the efficacy were analyzed The ORR in the Keytruda 400 mg Q6W protocol treatment group was 38.6% (n?17/44; 95% CI: 24.4-54.5), 9.1% of the full remission rate (CR), and 29.5% (n?13/44) in the keytruda 400 mg Q6W treatment group The results were comparable to the results of the melanoma previously evaluated keytruda monotherapy in addition, the PK of Keytruda 400mg Q6W is exposed to the clinical experience of other experimental dosage regimens The 400mg Q6W valley concentration is comparable to the Keytruda 200mg and 2mg/kg once every three weeks (Q3W) and the peak concentration is lower than the Keytruda 10mg/kg once every two weeks (Q2W) scheme Keytruda 400mg Q6W's safety profile is consistent with the keytruda 200mg Q3W, which has been proven in more than 12 tumor types 97.7% (n-43/44) patients experienced any level of all-cause adverse events In patients with 25.0% (n-11/44), level 3-4 all-cause adverse events occurred 68.2% (n-30/44) patients developed treatment-related adverse events (TRAE) In patients with 2.3% (n-1/44) there was a level 3-4 metastasis There are no treatment-related deaths (biovalleybioon.com) original source: Firt Clinical Outcome Evaluating Six-Week Schedule for Merck's KEYTRUDA ® (pembrolizumab) Preented at AACR Virtual Annual Meeting I