Last month, FDA approved the PD-1 antibody Keytruda as the first antitumor therapy that does not depend on the source of the tumor and is based on biomarkers. This week, the journal Science published an important paper that further confirmed the strength of Keytruda as a &ldquo, a broad-spectrum anticancer drug &rdquo.
As a key component of the revolutionary cancer immunotherapy, the PD-1/PD-L1 antibody has received great attention because of its amazing &ldquo and the anti-cancer performance &rdquo.
Since 2014, the FDA has approved PD-1/PD-L1 antibodies for the treatment of melanoma, non-small cell lung cancer, renal cell carcinoma, classical Hodgkin lymphoma, head and neck cancer, bladder cancer, Merkel cell carcinoma and carrying high microsatellite instability (MSI-H) or defective mismatch repair (dMMR) solid tumor.
When these indications were approved, there were &ldquo and two things ” it caused a little sensation. One thing is that PD-1 antibody Keytruda was approved for the first line treatment of non-small cell lung cancer in October last year. The other thing is that in May of this year, FDA approved Keytruda to become the first &ldquo, the broad-spectrum anticancer drug &rdquo, the solid tumor used for treatment of &ldquo, MSI-H/dMMR subtype &rdquo. This is the first time that FDA has approved a new drug based on the tumor biomarker rather than the original location of the tumor.
In June 8th, PD-1 antibody was identified as &ldquo, broad-spectrum anticancer drug &rdquo, and a new paper published in Science magazine.
Previously, in a conceptual validation study, previous work of scientists has confirmed that colorectal cancer with MMR deficiency (MMR-deficient) is more sensitive to PD-1 antibody Keytruda. In this new study, the researchers expanded the scope of the research, and evaluated the therapeutic effect of PD-1 antibody on 12 different advanced tumors (1 and 2) with MMR deficiency.
The study related clinical trials (NCT01876511) recruited 86 patients between September 2013 and September 2016. All patients received at least one previous treatment (prior therapy) and were progressing before the recruitment.
The results showed that 53% of the patients (46 people) achieved objective radiographic remission, and 21% of the patients (18) had complete remission. 77% of the patients (66 people) were controlled, including partial remission, complete remission, and condition stability (stable disease) (Table 1).
In terms of safety, the adverse reactions of Keytruda in these patients were controlled, similar to those observed in other clinical studies.
In addition, functional analysis of response patients (responding patient) revealed that neoantigen specific (neoantigen-specific) T cell clones were rapidly amplified in vivo. These T cells can play a role in the mutation of neopeptides found on the tumor.
The researchers believe that these data support a hypothesis that no matter what the origin of cancer tissue is, for a MMR deficient cancer, a large number of mutant neoantigen will make them more sensitive to immune checkpoint blocking therapy.
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At present, Keytruda has not yet been listed on the mainland of China. If patients want to get the treatment, they can only go to the United States or Hongkong through overseas. Hangzhou Health Management Co., Ltd. provides an overseas medical direct train to help patients travel to cost-effective medical institutions.
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