The seminar was held at Chandrakasem Rajabhat University. ![]() Accessed February 22, 2022.China's ambassador to Thailand Han Zhiqiang on Monday gives his keynote address at a forum titled 'Contemporary China with the World: An exchange of a new generation between Thailand and China' at Chandrakasem Rajabhat University. (Photo: Varuth Hirunyatheb)Ĭhinese ambassador Han Zhiqiang on Monday expressed confidence that China's Belt and Road Initiative would promote mutual growth and bring benefits to Thailand and China.ĭelivering a keynote speech at a seminar on "Contemporary China with the World: An exchange of a new generation between Thailand and China", the ambassador said the Belt and Road Initiative, which was intended to promote joint development, played a role in guiding and advancing bilateral relations and created a new open and inclusive system for development. FDA grants accelerated approval to pembrolizumab for first tissue/site agnostic indication. FDA Approves FoundationOne®CDx as a Companion Diagnostic for KEYTRUDA® (pembrolizumab) to Identify Patients with Microsatellite Instability-High (MSI-H) Solid Tumors. Immune-mediated side effects associated with pembrolizumab include pneumonitis, colitis, hepatitis, endocrinopathies, and nephritis.ġ. In its news release on the approval, the FDA listed common side effects of pembrolizumab, including fatigue, pruritus, diarrhea, decreased appetite, rash, pyrexia, cough, dyspnea, musculoskeletal pain, constipation, and nausea. In patients with metastatic CRC, 84% had received at least 2 prior lines of therapy, compared with 53% in patients with other solid tumors.īeyond CRC, other tumor types in which patients had responses included endometrial cancer (n = 5), biliary cancer (n = 3), gastric or GE junction cancer (n = 5), pancreatic cancer (n = 5), small intestinal cancer (n = 3), breast cancer (n = 2), prostate cancer (n = 1), esophageal cancer (n = 1), retroperitoneal adenocarcinoma (n = 1), and small cell lung cancer (n = 1). Among patients with metastatic or unresectable disease, the median number of prior therapies was 2. Two percent of patients had locally advanced, unresectable disease, and 98% of patients had metastatic disease. Across the population, 77% of patients were white, 56% were male, 36% had an ECOG performance status (PS) of 0, and 64% had an ECOG PS of 1. The median age among the 149 patients was 55 years, with 36% of patients aged 65 or older. Pembrolizumab was administered at 200 mg every 3 weeks or 10 mg/kg every 2 weeks until disease progression, unacceptable toxicity, or a maximum of 24 months. The pivotal data for the approval included patients from the KEYNOTE-016 (n = 58), KEYNOTE-164 (n = 61), KEYNOTE-012 (n = 6), KEYNOTE-028 (n = 5), and KEYNOTE-158 (n = 19) trials. Among patients who responded to pembrolizumab, 78% had responses that lasted for at least 6 months. The median duration of response was not yet reached (range, 1.6+ months to 22.7+ months). The ORR was 36% in patients with CRC and 46% in patients with other tumor types. The objective response rate (ORR) with pembrolizumab was 39.6% (95% CI, 31.7-47.9), including 11 (7.4%) complete responses (CRs) and 48 (32.2%) partial responses (PRs). ![]() Ninety patients had colorectal cancer (CRC) and the remaining 59 patients had 1 of 14 other tumor types. The 2017 approval of pembrolizumab for patients with MSI-H/dMMR solid tumors was based on data from 149 patients with MSI-H or dMMR cancers enrolled across 5 single-arm clinical trials. “Not only could this approval allow more patients to benefit from Keytruda, but it also underscores an important shift toward tumor-agnostic cancer care.” Approval of pembrolizumab for MSI-H “Immunotherapy has huge promise as a potential treatment option for patients with advanced cancer however, identifying those who may benefit is complex and requires high-quality diagnostics,” Mia Levy, MD, PhD, chief medical officer at Foundation Medicine, the developer of FoundationOneCDx stated in a news release. 2 The emergence of such tumor-agnostic approvals has increased the significance of genomic profiling in urology, as patients with prostate, bladder, or kidney cancer may benefit from these therapies. Pembrolizumab was approved by the FDA in 2017 for the treatment of patients with MSI-H or mismatch repair deficient solid tumors. The FDA has approved FoundationOneCDx for use as a companion diagnostic to identify patients with solid tumors that are microsatellite instability high (MSI-H) and thus eligible to be treated with the immunotherapy pembrolizumab (Keytruda).
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