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    Home > Active Ingredient News > Antitumor Therapy > FDA News . . . Paboli sepsal lightning was approved for first-line treatment of MSI-H/dMMR metastatic colorectal cancer.

    FDA News . . . Paboli sepsal lightning was approved for first-line treatment of MSI-H/dMMR metastatic colorectal cancer.

    • Last Update: 2020-07-18
    • Source: Internet
    • Author: User
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    On June 29, 2020, FDA approved pembrolizumab as the first-line treatment for unresectable or metastatic colorectal cancer (mCRC) with high microsatellite instability / mismatch repair defect (MSI-H / dmmr).the approval is based on the results of the phase III keynote-177 (nct02563002) study just released at this year's ASCO annual meeting: compared with the current standard treatment (chemotherapy ± bevacizumab or cetuximab), the first-line treatment of pabolizumab brings clinical and statistically significant PFS improvement in patients with MSI-H MCRC, with the median PFS extended from 8.2 months to 16.5 months The risk of developing or dying was reduced by 40%.MSI-H / dmmr population accounts for about 5% of MCRC patients. In recent years, MSI-H has been widely recognized as a biomarker of CRC immunotherapy. Studies such as keynote-164 and checkmate-142 have confirmed the efficacy of PD-1 inhibitors in the treatment of MSI-H / dmrr MCRC. Thekeynote-177 research is undoubtedly the most concerned research in the field of ASCO colorectal cancer this year. It is the first phase III clinical trial to compare the first-line application of immunomonotherapy and chemotherapy in MSI-H / dmmr colorectal cancer patients.a total of 307 patients with MSI-H / dmmr metastatic colorectal cancer were included in the study, with ECoG PS of 0-1.the first-line treatment was randomized to receive pabolizumab (200 mg q3w, up to 2 years) or chemotherapy of the investigator's choice (mfolfox6 or FOLFIRI q2w ± bevacizumab or cetuximab, the chemotherapy regimen was determined before randomization).treatment to disease progression, unacceptable toxicity, patients or researchers decide to withdraw, or complete 35 cycles of treatment (pabolizumab only).patients receiving chemotherapy can cross over to pabolizumab group to complete up to 35 cycles of treatment after confirming progress.the primary endpoint was progression free survival (PFS) as assessed by RECIST 1.1, and the secondary end points included objective response rate (ORR) and safety as assessed by RECIST 1.1.efficacy results showed that the median PFS of pabolizumab group was 16.5 months, which was significantly better than 8.2 months of standard chemotherapy group, and the risk of disease progression or death was reduced by 40% (HR 0.60, 95% CI 0.45-0.80, P = 0.0002).PFS rates at 12 and 24 months were 55.3% and 48.3% in the pabolizumab group and 37.3% and 18.6% in the chemotherapy group.confirmed orr were 43.8% and 33.1% in the two groups, respectively; the median (range) duration of remission was not achieved in the pabolizumab group (2.3 + to 41.4 +) and 10.6 months (2.8 to 37.5 +) in the chemotherapy group.the incidence of grade 3-5 treatment-related adverse events (AE) was 22% in the pabolizumab group and 66% in the chemotherapy group.there was 1 treatment-related death in the chemotherapy group.conclusion in May 2017, the FDA approved the use of pabolizumab in the treatment of patients with unresectable or metastatic MSI-H / dmmr solid tumors who have progressed after previous treatment or have no satisfactory alternative treatment, or who have progressed after 5-FU, oxaliplatin and irinotecan.the publication of keynote-177 research results has added new evidence for colorectal cancer immunotherapy. The first-line treatment indications approved by pabolizumab have brought new treatment options for MSI-H colorectal cancer patients.References: [1] FDA approved Merck's keytruda (pembrolizumab) first line treatment of patients with refractory or metallic MSI-H or dmmr chromatic cancer. News release. Merck. June 29, 2020. Accessed June 29, 2020 bwnews.pr/3ePxyfu .[2] Andre T. Shiu Kai-Keen, Kim TW,et al. Pembrolizumab versus chemotherapy for microsatellite instability-high/mismatch repair deficient metastatic colorectal cancer: The phase 3 KEYNOTE-177 study. J Clin Oncol. 2020;38(suppl 15; abstr LBA4).doi:10.1200/JCO.2020.38.15_ suppl.LBA4 [3] FDA grants accelerated approval to pembrolizumab for first tissue/site agnostic indication. News release. FDA. May 23, 2017. Accessed June 29, 2020.bit.ly/3bI0DHK .
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