K medicine mighty! Mercedon Keytruda single-drug first-line treatment for PD-L1-positive lung cancer was approved by the FDA for priority examination:

The U.S. Food and Drug Administration (FDA) has accepted and granted priority vetting status to a new biological product licensing application (sBLA) for PD-1 oncology immunotherapy Keytruda (pembrolizumab, Pabli pearl monoanti). The sBLA aims to seek approval of Keytruda as a single-drug therapy for patients with first-line tumor expression PD-L1 (TPS≥1%) and local late stage or metastasis non-squamous or squamous non-small cell lung cancer (NSCLC) without EGFR or ALC genomic tumor distortion. The FDA has designated the SBLA's Prescription Drug User Charge Act (PDUFA) date as January 11, 2019.
sBLA submission is based on the total lifetime (OS) data of KEYNOTE-042, a critical Phase III clinical study. The study is one of five key Phase III clinical studies conducted by Mercedon to demonstrate that Keytruda's treatment of NSCLC significantly improves OS.
KEYNOTE-042 is an international, randomized, open-label study (NCT02220894) that assessed the efficacy and safety of truKeyda as a single-drug therapy relative to platinum-containing chemotherapy in patients with local late stage or metastasis PD-L1 positive (TPS≥1%) NSCLC (including non-scale and squamous histological types). In the study, patients in the group did not have EGFR or APK tumor genomic distortion and had not previously received systematic therapy to treat advanced diseases. The main endpoints of the study were the evaluation of OS ≥ 50%, ≥ 20%, ≥ 1% of patients. Secondary endpoints include PFS and Objective Mitigation Rate (ORR).
the study included 1,274 patients who were randomly treated with Keytruda monodrugs (200 mg at a fixed dose every 3 weeks) or platinum-containing chemotherapy options selected by the researchers, including: (1) scaly NSCLC patients, with a chemotherapy option of capratin AUC 5 or 6 mg/mL/min combined with sequoia 200mg/m2, once every 3 weeks (Q3W), up to 6 cycles of chemotherapy, (2) non-scaly NSCLC patients, chemotherapy options for carbap AAUC 5 or 6mg/mL/min combined 500mg/m2 Q3W, up to 6 cycles of chemotherapy, followed by optional 500mg/m2.
results showed that an interim analysis conducted by THEC showed that Keytruda single-drug therapy significantly extended OS in 1% of patients with PD-L1 TPS compared to platinum-containing chemotherapy (carptonin-sequoia≥ As part of the pre-designated analysis program, the DMC evaluated TPS≥50%, ≥20%, ≥1% of patients in turn, and the results showed that Keytruda was 50% (HR-0.69) in TPS≥ %CI: 0.56-0.85, p=0.0003), TPS≥20% (HR=0.77 (95% CI:0.64-0.). 92', p=0.0020), TPS≥1% (HR=0.81 (95% CI: 0.71-0.93), p=0.001 8) OS was significantly extended in patients, with the middle OS being 20.0 months (12.2 months in the control group), 17.7 months (13.0 months in the control group) and 16.7 months (12.1 months in the control group). In this study, the safety of Keytruda was consistent with previously reported Studies of Keytruda Single Drug Treatment for Advanced NSCLC.Dr. Roy Baynes, Senior Vice President and Global Clinical Development Officer,
Mercedon Research Laboratory, said keytruda is now a cornerstone of metastasis NSCLC clinical treatment, and we are pleased that the FDA has granted this new sBLA priority review qualification, and look forward to the expansion of Keytruda monodrug adaptation to the local late stage or metastasis NSCLC patient population of PD-L1-positive (TPS≥1%).
analysts point out that the sBLA is significant for Mercadon and, if approved, would triple the pool of potential lung cancer patients treated with Keytruda's single-drug first-line treatment, meaning that the entire PD-L1-positive lung cancer patient population (TPS≥1 percent) would fall into Keytruda's patient pool. It is estimated that these patients account for 70 per cent of the group of patients treated with non-scaly NSCLC in the first line.
In addition to the KEYNOTE-042 study, Mercedon's clinical development program for lung cancer includes 10 Phase III studies that are evaluating the therapeutic potential of Keytruda monodharma and combination therapies in a variety of clinical contexts and for lung cancer at all stages. (Bio Valley)