PD-1 inhibitors become "anti-cancer artifacts", how are domestic and foreign companies progressing?

PD-1 inhibitors become "anti-cancer artifacts", how are domestic and foreign companies progressing?

July 21, 2015 Source: Biological Exploration

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Medical Network July 17 As immunotherapy has become an irresistible trend in cancer treatment, PD-1 inhibitors have become one of the most dazzling and heavy drugs. The most famous of these is Opdivo (nivolumab) developed by Bristol-Myers Squibb (BMS) and Keytruda (pembrolizumab) of the "old-to-head" Merck.

Last year, Opdivo and Keytruda received FDA approval for PD-1 inhibitors for melanoma in September and December, respectively. However, the industry believes that the market potential for melanoma indications is limited, and the prospects for PD-1/PD-L1 immunotherapy still depend on other tumors, such as non-small cell lung cancer (NSCLC).

　　 BMS and Merck, you chase me

The good news is coming soon. In early March of this year, Opdivo was approved by the US FDA for the treatment of metastatic squamous non-small cell lung cancer that is still progressing after chemotherapy. It took less than a week from the application to the approval, which set the record for the fastest innovative drug approval in history.

At the 51st American Society of Clinical Oncology (ASCO) held not long ago, BMS and Merck have launched a swipe mode, which announced a series of gratifying results in the treatment of different cancers with their respective PD-1 drugs. The smell of gunpowder that you chase after the two companies is getting stronger and stronger. But in general, BMS seems to be a little bit faster than Merck.

In mid-June, BMS's Opdivo was approved by the European Union for the treatment of advanced melanoma, making it the first PD-1 immunotherapy to open the European market. It was also the first PD to successfully win the three major markets of Japan, the United States and the European Union. -1 immunotherapy. At the same time, it is expected that the Opdivo lung cancer application is likely to be approved in July, becoming the first PD-1 immunotherapy for non-small cell lung cancer in the European market.

Several pharmaceutical giants seize the PD-1 market

Of course, it is impossible for these two pharmaceutical giants to compete for such a drug. Amgen and Lilly are also involved. In December last year, Amgen and Merck signed a strategic partnership in immuno-oncology to investigate the combination of cancer vaccine T-vec and PD-1 immunotherapy Keytruda for the treatment of advanced melanoma. Recently, the two sides expanded cooperation to use the immune cocktail for the treatment of recurrent or metastatic head and neck squamous cell carcinoma, and initiated the phase III clinical study of the immune cocktail for advanced melanoma.

Eli Lilly's layout in the PD-1 field is very interesting. At the beginning of this year, Lilly signed a trial protocol for tumor immunotherapy with the above two "dead rivals" to evaluate the combined therapeutic effect of the company's oncology drugs with PD-1 inhibitors.

Lilly and Merck will work together to develop Keytruda and Pemetrexed or Necitumumab as first-line therapy for non-small cell lung cancer, and the combined use of Keytruda and Ramucirumab in a variety of tumors. Lilly and BMS signed a cooperation agreement to develop a combination of Opdivo and Galunisertib for the treatment of brain tumors, liver cancer, and lung cancer. The details are not disclosed. The strategy of “Left Hand Lilly, Right Hand Merck” is really a profound layout.

Domestic: Received attention and results gradually emerged

Having said so many foreign countries, I put my eyes back home. From the perspective of reporting, the media's preference for PD-1 inhibitors has increased significantly. In addition to websites, newspapers, and public accounts, on June 14, 2015, CCTV's "News Live Room" made a session on "PD1 antibody became Special report on the mainstream direction of cancer treatment.

According to the introduction of the current program, Professor Zhang Ping identified the peripheral immunosuppressive molecule PD-1/PD-L1 and further developed the related work of monoclonal antibody; Professor Zhang Ping discovered that PD-L1 protein binds to the immune cell receptor PD-1. Similar to the role of car brakes, the immune cells that should have attacked the tumor cells stopped working. Based on this principle, Professor Chen's team antagonizes the binding between PD-1 and PD-L1 through monoclonal antibodies, thereby awakening immune cells, protecting lymphocyte activity, and conquering cancer cells through the patient's own immune system; It is proved that this treatment has a role in more than a dozen advanced cancers such as skin cancer, stomach cancer and bladder cancer. The average effective rate is between 30% and 50%, and about 5% of patients have side effects, regardless of efficacy or safety factor. This treatment is far superior to traditional therapies, whether it is radiotherapy, chemotherapy or targeted therapy.

From the company's point of view, domestic companies have also made some progress. On June 5, Baekje Shenzhou announced that its first phase of BGB-A317 clinical trial for advanced cancer treatment has been enrolled. Baekje Shenzhou is a company dedicated to the development of innovative drugs for targeting and immuno-tumor. BGB-A317 is a highly selective and potent all-human monoclonal antibody candidate against PD-1.

In addition to Baekje Shenzhou, the recombinant humanized anti-PD-1 monoclonal antibody injection of Taizhou Junshi Biomedical Technology Co., Ltd. has been submitted to the CFDA for approval, and is currently in the “approval” stage of drug registration. In addition, there are rumors that Hengrui Medicine 's SHR1210 may be an anti-PD-1 drug, and is currently in the “in review” stage.

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