Keytruda single-agent first-line treatment of NSCLC key phase III success April 10, 2018 Source: Sina Pharmaceutical On Friday, the US drug giant Merck & Co and Incyte developed the star combination therapy Keytruda/epacadostat for the Waterloo incident (see Sina Medical article: Star Combination therapy Keytruda/Epacadostat encounters Waterloo). However, the recent Merck lung cancer clinical project has brought good news. In the key phase III clinical study KEYNOTE-042, which has received much industry attention, Keytruda single-line first-line treatment of non-small cell lung cancer (NSCLC) significantly prolonged overall survival (OS) and reached the primary end point of the study. Based on the recommendations of the Independent Data Monitoring Committee (DMC), the study will continue to evaluate PFS. The results from the study will be synchronized at the upcoming medical conference and submitted to regulatory authorities around the world. KEYNOTE-042 is an international, randomized, open-label phase III study conducted in patients with locally advanced or metastatic PD-L1 positive (tumor ratio score [TPS] ≥ 1%) NSCLC who have not received previous treatment. The efficacy and safety of Keytruda as a monotherapy for first-line therapy versus platinum-containing chemotherapy. It should be noted that patients enrolled in the study did not have EGFR or ALK tumor genomic aberrations and had not previously received systemic therapy for advanced disease. The primary endpoint of the study was to sequentially evaluate OS in patients with TPS ≥ 50%, ≥ 20%, ≥ 1%. Secondary endpoints included PFS and objective response rate (ORR). A total of 1274 patients were enrolled in the study. Patients were randomized to receive either Keytruda monotherapy (200 mg once every 3 weeks) or platinum-selective chemotherapy regimens selected by the investigators, including: (1) scales. In patients with NSCLC, the chemotherapy regimen is carboplatin AUC 5 or 6 mg/mL/min combined with paclitaxel 200 mg/m2 once every 3 weeks (Q3W), with up to 6 cycles of chemotherapy; (2) non-squamous NSCLC patients, chemotherapy regimen is card Platinum AUC 5 or 6mg/mL/min combined with pemetrexed 500mg/m2 Q3W, up to 6 cycles of chemotherapy, followed by optional pemetrexed 500mg/m2. The study showed that an interim analysis by DMC showed that Keytruda monotherapy was in patients with PD-L1 TPS ≥ 1% compared with platinum-containing chemotherapy (carboplatin + paclitaxel or carboplatin + pemetrexed) Significantly extended OS. As part of the pre-specified analysis plan, DMC evaluated patients with TPS ≥ 50%, ≥ 20%, ≥ 1% in turn, and the results showed that Keytruda was TPS ≥ 50%, TPS ≥ 20%, and the entire study population (TPS ≥ 1%) significantly extended the OS. In this study, the safety of Keytruda was consistent with the previously reported study of Keytruda monotherapy for advanced NSCLC. Lung cancer field: Merck's dominant pool of patients will significantly expand 3 times On a global scale, lung cancer is the leading cause of cancer-related deaths. Therefore, lung cancer is a truly extremely profitable treatment market compared to melanoma and other types of cancer. NSCLC is the most common type of lung cancer, accounting for about 85% of all lung cancer cases, and about 75% of NSCLC patients will be diagnosed with metastatic or advanced disease with a very poor prognosis. Prior to this, Keytruda had taken an absolute leading position in the field of lung cancer immunotherapy. The drug is still the only PD-1/PD-L1 immunotherapy for the first-line treatment of NSCLC, and its indications for lung cancer have been Up to 3: (1) single-agent first-line treatment of TPS ≥ 50% of metastatic NSCLC; (2) single-agent second-line treatment of TPS ≥ 1% of metastatic NSCLC with previous progression of chemotherapy; (3) combined with pemetrexed And carboplatin for the treatment of metastatic non-squamous NSCLC. The success of KEYNOTE-042 will triple the potential lung cancer patient population of Keytruda single-line first-line treatment, which means that the entire PD-L1-positive lung cancer patient population (TPS ≥ 1%) will fall into Keytruda's patient pool ( Patient pool), it is estimated that these patients accounted for 70% of the first-line treatment of non-squamous NSCLC patients. At present, Merck is actively promoting a wide range of lung cancer clinical development projects, including 15 clinical studies, enrolling nearly 9000 patients, and is evaluating Keytruda monotherapy and combination therapy in a variety of clinical settings and for various stages of lung cancer. The therapeutic potential. (Sina Pharmaceutical Compilation/newborn) Reference source: 1, KEYTRUDA? (pembrolizumab) Monotherapy Met Primary Endpoint in Phase 3 KEYNOTE-042 Study, Significantly Improving OS as First-Line Therapy in Locally Advanced or Metastatic NSCLC Patients Expressing PD-L1 in at Least 1 Percent of Tumor Cells 2, Merck's Keytruda upends lung cancer market with latest survival win Shaanxi Kang New Pharmaceutical co., Ltd. , https://www.kangnewpharmas.com