Tumor mutation load approved by FDA keytruda second "unlimited cancer" indication approved

The FDA has accelerated approval of Keytruda, a heavy PD-1 inhibitor developed by MSD, according to the FDA's official website todayNon-removable or metastatic solid tumor patients with high mutation load (TMB-H) for single-drug treatment of tumors and progression of disease after previous treatment, regardless of cancer typeThese patients had TMB in tumor tissue with tMG of 10 mutations/million bases, developed disease progression after previous treatment, and there was no satisfactory alternative treatmentthis is the first time that tumor mutation loadhasd from the FDA to be a biomarker that guides patient treatment optionsThis approval is expected to further expand the range of patients treated with Keytruda, as well as other PD-1/PD-L1 inhibitors, for the benefit of more cancer patients, Keytruda received FDA approval in 2017 to become the world's first biomarker-based "unlimited cancer" cancer treatment for microsatellite instability (MSI-H) or mismatch repair defect (dMMR) solid tumorsMSI-H is due to mismatch repair defects that cause a very large number of genetic mutations in specific areas of DNAPatients with MSI-H responded significantly to PD-1/PD-L1 inhibitors, reaching approximately 50%However, with the exception of colorectal cancer and endometrial cancer, the incidence of MSI-H in other cancer types is not high, so the use of MSI-H to screen patients can affect a small number of patientsprevious studies have shown that in patients with TMB-H, the proportion of patients with MSI-H at the same time is between 15% and 40% (how to define TMB-H has a significant impact on this number), so checkpoint inhibitors may benefit more patients if TMB-H can be used as a molecular biomarker to screen cancer patientsthis approval is based on a multicenter, multi-queue, non-random, open-label trial called KEYNOTE-158In this trial, different types of patients with treated metastatic solid tumors were treated with Keytruda monodrugThe total remission rate (ORR) for TMB-H patients reached 30.3%, including 4% full remission and 26.3% partial remissionIn non-TMB-H patients, the ORR was 6.7%After one year, the progression survival rate was 26.4% in tMB-H patients, while in non-TMB-H patients, the non-progression survival rate was 14.1%in terms of total survival (OS), the median OS (11.7 months) in TMB-H patients was shorter than in non-TMB-H patients (13.0 months)It is worth noting here that tumors carried by Patients with TMB-H may progress faster or be more invasive due to more genetic mutations, resulting in a worse prognosis than non-TMB-H patients in the age of individualized therapies, doctors aim to find the best treatment for patients by conducting deeper analysis Based on the analysis and screening of tumor mutation status, which is most suitable for immunocheckpoint inhibitor treatment, is an important part of improving the efficacy of immunocheckpoint inhibitors In this year's ASCO annual meeting, the results of clinical trials presented by Mercadon showed that Keytruda doubled the patient's progression-free survival (16.5 months vs 8.2 months) compared to chemotherapy in the treatment of MSI-H/dMMR colorectal cancer patients This means that treatments based on MSI-H/dMMR, a biomarker, are expected to be among the first-line therapies the approval of Keytruda, an "unlimited cancer" application, is an important step in TMB's emergence as a biomarker for individualized therapies We look forward to further refining and standardizing TMB testing so that more patients can be prescreened to find the best treatment for them original title: Tumor mutation load approved by FDA for the first time auxiliary treatment options, Keytruda second "unlimited cancer" indicationisis approved