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European approval of PD-1 antibody line for lung cancer
更新时间:2017-02-16

In January 31st, the European Commission (EC) announced that the PD-1 antibody Keytruda could be used for the first line treatment of advanced PD-L1 - positive non - small cell lung cancer in Europe. That is to say, for some patients with advanced lung cancer, first line treatment can be used directly with Keytruda, with small side effects, high efficiency and long living time. However, the patients who did not include the EGFR mutation and ALK fusion continued to use the targeted drug.

In fact, as early as October 24th 2016, FDA had approved Keytruda first-line treatment for lung cancer patients in the United States for high expression of PD-L1 (greater than 50%). This is the first time that the PD-1 antibody is approved for the first line treatment of lung cancer.

The European Union's approval of this indication is also an important clinical trial based on Keytruda, -Keynote-024. The results of clinical trials were published in the world's top medical journal New England Journal of medicine in October 9, 2016.

A total of 305 patients from 16 countries were included in the trial. There were no mutations in EGFR and ALK genes. They were randomly assigned to Pembrolizumab group and platinum based chemotherapy group according to 1:1. The efficiency of the two groups was compared in the untreated progress, the high expression of PD-L1 (high expression definition: the expression rate of more than 50% in the tumor cells) in NSCLC.

A total of 154 patients in group Pembrolizumab, 200mg, and 3 weeks, and 151 patients in the chemotherapy group, and the chemotherapy regimen varied from person to person.

The effective rate of the group treated with Keytruda was 44.6%, the median progression free survival was 10.3 months, median duration has not yet reached 3, above the level of the side effect rate is 26.5%; while the effective rate of this group received chemotherapy was 27.8%, median progression free survival a period of 6 months, the median duration is 6.3 months, more than 3 of the side effect rate is 53.3%.

These data indicate that for patients with strong PD-L1 positive, the first line use of Keytruda is more effective than chemotherapy, with small side effects and is not susceptible to drug resistance.

The data are compared as follows:

PD-1 antibody Keytruda compared with chemotherapy in the first line of NSCLC— Keynote024

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The study was published, China's famous scientist Professor Wu Yilong had lung cancer with “ &rdquo to describe the weather. Why use &ldquo to change; ” this word? Because the improvement of the total survival is not easy.

Targeted therapy is effective, but the total survival is always on the same level. KEYNOTE-024, even if it crossover to Pembrolizumab before chemotherapy, is still not as good as the first line. Patients in the initial treatment need to detect the driving genes and PD-L1, so more than half of the patients with advanced lung cancer can be free from chemotherapy.