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Merck’s Keytruda+platinum chemotherapy phase 3 clinical success
Merck’s Keytruda+platinum chemotherapy phase 3 clinical success. First-line immunotherapy for cervical cancer! Merck‘s Keytruda+platinum chemotherapy phase 3 clinical success: significantly prolonged overall survival (OS) and progression-free survival (PFS)!
Merck & Co recently announced the evaluation of the anti-PD-1 therapy Keytruda (generic name: pembrolizumab, pembrolizumab) for the first-line treatment of the cervix Results of the Cancer Critical Phase 3 KEYNOTE-826 trial (NCT03635567). The trial included 617 cases of persistent, recurrent, or metastatic cervical cancer (including squamous cell carcinoma, adenosquamous carcinoma) that have not previously received systemic chemotherapy and are no longer suitable for radical treatment (such as surgery and/or radiotherapy). , Adenocarcinoma) in adult patients, is evaluating Keytruda versus placebo, combined with platinum chemotherapy (paclitaxel + cisplatin, or paclitaxel + carboplatin) with or without bevacizumab for first-line treatment Efficacy and safety. The primary endpoints of the study are overall survival (OS) and progression-free survival (PFS). Secondary endpoints include: overall response rate (ORR), duration of response (DOR), and safety.
The results showed that the trial reached the primary endpoints of OS and PFS. According to an interim analysis conducted by the Independent Data Monitoring Committee (IDMC), regardless of the patient’s tumor PD-L1 status, compared with the control regimen (placebo + platinum chemotherapy regimen, with or without bevacizumab), the Keytruda regimen (Keytruda + the same platinum-based chemotherapy regimen, with or without bevacizumab) showed statistically significant and clinically significant improvements in OS and PFS.
According to the test results, Keytruda is the first anti-PD-1/PD-L1 therapy to prove this. In this trial, the safety of Keytruda is consistent with that reported in previous studies. The results of the trial will be announced at an upcoming medical conference and will be submitted to regulatory agencies.
Dr. Roy Baynes, Chief Medical Officer, Senior Vice President and Head of Global Clinical Development of Merck Research Laboratories, said: “Despite progress in prevention and screening, cervical cancer is still a major health problem that often affects young and middle-aged people. Women. Women diagnosed with metastatic cervical cancer have a particularly poor prognosis and urgently need new treatment options. KEYNOTE-826 is the first study to show positive results of immunotherapy in first-line persistent, recurrent or metastatic cervical cancer. We We look forward to sharing these findings and discussing with regulatory agencies at the upcoming conference. We thank patients, their caregivers and researchers for participating in this important research.”
The Phase 3 KEYNOTE-826 trial is also a confirmatory trial for accelerating the approval of Keytruda for the treatment of cervical cancer. In June 2018, Keytruda received accelerated approval from the U.S. FDA for second-line treatment of patients with recurrent or metastatic cervical cancer, specifically: disease progression during or after chemotherapy, and FDA-approved detection methods confirmed that tumors express PD-L1 (combined positive Women with recurrent or metastatic cervical cancer with score [CPS]≥1).
Under this accelerated approval, Keytruda becomes the first PD-1 immunotherapy approved for the treatment of advanced cervical cancer. This approval also marks Keytruda’s first indication in the field of gynecological cancer. Data from Phase II KEYNOTE-158 cohort E showed that in PD-L1 positive (CPS≥1) patients, the overall response rate (ORR) of Keytruda treatment was 14.3%, while in PD-L1 negative (CPS<1) patients No treatment response was observed in the patient.
Cervical cancer is the fourth leading cause of cancer deaths in women worldwide. Although cervical cancer may occur in women of any age, it is most common in women aged 35-44. Almost all cases are caused by human papillomavirus (HPV) infection, about 80% are classified as squamous cell carcinoma (SCC, cells originating from the bottom of the cervix), and most of the rest are adenocarcinoma (originating from the cervix) Upper glandular cells).
Although progress has been made in routine medical screening and prevention (HPV vaccine), cervical cancer is still widespread. It is estimated that there are more than 600,000 newly diagnosed cervical cancer cases worldwide and more than 340,000 deaths every year. Cervical cancer is usually curable when it is detected early and effectively treated, but treatment options for advanced, recurrent or metastatic cervical cancer are limited, and the survival rate is very low. In the United States, the 5-year survival rate for patients diagnosed with cervical cancer who has spread to distant parts of the body is estimated to be about 17%.
(source:internet, reference only)