Is this set value correct? The cut-off value of TMB should be examined based on future clinical data.Ģ. 10 / Mb is set as the cutoff value as the TMB value. The following points have been pointed out as problems in future cancer genomic medicine.ġ. On the other hand, in cancer genomic medicine at a national university in Japan, treatment with Nivolumab or Atezolizumab was recommended for cases determined to be TMB (10 <). Most of the cases determined to be MSI-H were solid tumors resistant to platinum. There were 4 cases with TMB of 20 or more. In addition, a total of 25 cases (Ncc oncopanel test: 6 cases, F1CDx test: 19 cases) were determined to be TMB (10 <). On 16 June 2020, the US Food and Drug Administration (FDA) granted accelerated approval to pembrolizumab for the treatment of ‘adult and pediatric patients with unresectable or metastatic tumor mutational burden-high (TMB-H) solid tumors, as determined by an FDA-approved test, that have progressed following prior treatment and who have no satisfactory alternative treatment options.ĭuring the period from December 2019 to December 2020, treatment methods for total of 576 cases (Ncc oncopanel test: 129 cases, F1CDx test: 447 cases) were examined in cancer genomic medicine at a national university in Japan.įrom the examination results, total of 33 cases (test with Ncc oncopanel: 8 cases, test with F1CDx: 25 cases) were determined to be MSI-H. Therefore, based on the results of the KEYNOTE-158 trial, an application for approval of pembrolizumab for TMB-H (10 <) solid tumors was submitted. In the solid cancer of MSI-High, the value of the TMB has been found very high. In 2017, based on a common biomarker across cancer types, pembrolizumab was approved by the FDA for solid tumors with MSI-High or mismatch repair deficiency (dMMR). Shared Decision Making and Communication.Scientific Discovery and the Future of Medicine.Health Care Economics, Insurance, Payment.Clinical Implications of Basic Neuroscience.Challenges in Clinical Electrocardiography.
On the basis of these results, the US Food and Drug Administration granted accelerated approval of pembrolizumab for patients with advanced PD-L1-positive cervical cancer who experienced progression during or after chemotherapy. Pembrolizumab monotherapy demonstrated durable antitumor activity and manageable safety in patients with advanced cervical cancer. Treatment-related grade 3 to 4 adverse events occurred in 12.2% of patients. Treatment-related adverse events occurred in 65.3% of patients, and the most common were hypothyroidism (10.2%), decreased appetite (9.2%), and fatigue (9.2%). Median duration of response was not reached (range, ≥ 3.7 to ≥ 18.6 months). All 12 responses were in patients with PD-L1-positive tumors, for an ORR of 14.6% (95% CI, 7.8% to 24.2%) 14.3% (95% CI, 7.4% to 24.1%) of these responses were in those who had received one or more lines of chemotherapy for recurrent or metastatic disease. ORR was 12.2% (95% CI, 6.5% to 20.4%), with three complete and nine partial responses. Median follow-up was 10.2 months (range, 0.6 to 22.7 months). Eighty-two patients (83.7%) had programmed death-ligand 1 (PD-L1)-positive tumors (combined positive score ≥ 1), 77 having previously received one or more lines of chemotherapy for recurrent or metastatic disease. Median age was 46.0 years (range, 24 to 75 years), and 65.3% of patients had Eastern Cooperative Oncology Group performance status of 1. The primary end point was objective response rate (ORR), assessed per Response Evaluation Criteria in Solid Tumors (version 1.1) by independent central radiologic review. Tumor imaging was performed every 9 weeks for the first 12 months and every 12 weeks thereafter. Patients received pembrolizumab 200 mg every 3 weeks for 2 years or until progression, intolerable toxicity, or physician or patient decision. We present interim results from patients with previously treated advanced cervical cancer. KEYNOTE-158 ( identifier: NCT02628067) is a phase II basket study investigating the antitumor activity and safety of pembrolizumab in multiple cancer types.
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