Envolimab has been recommended by 6 CSCO guidelines and has unlimited prospects in the field of multitumors

*For medical professionals only

Congratulations to Envolimab for winning the 2022 CSCO Ovarian Cancer Guidelines recommendation!

Simcere Pharmaceutical, Sidi Pharmaceutical, and Corning Jereh Biopharma strategic cooperation between Simcere Pharmaceutical, Sidi Pharmaceutical, and Corning Jereh Biopharmaceutical, the world's first PD-L1 antibody drug for subcutaneous injection and administration, Envolimab, which was approved for marketing in November last year, has been recommended by six new guidelines of the Chinese Society of Clinical Oncology (CSCO), including: "CSCO Gastric Cancer Diagnosis and Treatment Guidelines 2022 Edition", "CSCO Colorectal Cancer Diagnosis and Treatment Guidelines 2022 Edition", " CSCO Guidelines for the Diagnosis and Treatment of Cervical Cancer 2022 Edition, CSCO Ovarian Cancer Guidelines 2022 Edition, and CSCO Immune Checkpoint Inhibitor Clinical Application Guidelines 2022 Edition, covering gastrointestinal tumors, gynecologic tumors and microsatellite highly unstable (MSI-H)/mismatch repair gene deficient (dMMR) advanced solid tumors
.

Tumors of the digestive tract

For metastatic advanced gastric cancer, the CSCO Gastric Cancer Guidelines 2022 Edition states that dMMR/MSI-H people (regardless of HER2 status) who have not previously used PD-1/PD-L1 monoclonal antibody are recommended for envolimab treatment (class I recommendation, class 2A evidence).

This update is based on the results of the Chinese multicenter, single-arm Envolimab CN-006 Phase II study ^[1], which included a total of 18 patients with advanced gastric cancer with MSI-H/dMMR, who had received at least first-line therapy and were treated with envolumab after enrollment, with an overall objective response rate (ORR) of 55.
6%, and median overall survival (OS) was not reached at the time of data analysis, with a 12-month OS rate of 77.
4%.

For metastatic colorectal cancer, the CSCO Guidelines for the Diagnosis and Treatment of Colorectal Cancer 2022 Edition states that envolimab is recommended for the second- and third-line treatment of MSI-H/dMMR initial unresectable metastatic colorectal cancer not previously treated with immune checkpoint inhibitors (level II recommendation, class 2A evidence).

This update is also based on the results of the CN-006 phase II study of envolimab ^[1], which included a total of 65 patients with advanced colorectal cancer with MSI-H/dMMR with an ORR of 43.
1%, median OS not reached as of data analysis, and a 12-month OS rate of 72.
0%.

MSI-H/dMMR advanced solid tumors

For advanced solid tumors, the CSCO Immune Checkpoint Inhibitor Clinical Application Guidelines 2022 Edition recommends envolimab for the second-line and above treatment of MSI-H/dMMR advanced solid tumors (grade I recommendation, class 2A evidence).

This update is also based on the results of the CN-006 phase II study of envolimab ^[1], which included a total of 20 patients with MSI-H/dMMR advanced solid tumors (except colorectal cancer and gastric cancer) with an ORR of 40%, and as of the time of data analysis, the median OS was not reached, and the 12-month OS rate was 75.
0%.

Gynecologic tumors

Endometrial, cervical and ovarian cancers are common gynecologic malignancies in Chinese women, and some patients are diagnosed at an advanced stage or have relapsed and metastasized
after treatment 。 Now envolimab has successfully obtained the recommendation of the "CSCO Endometrial Cancer Diagnosis and Treatment Guidelines 2022 Edition" and "CSCO Cervical Cancer Diagnosis and Treatment Guidelines 2022 Edition" for the second-line treatment of MSI-H/dMMR recurrent or metastatic endometrial cancer and cervical cancer (level II recommendation), and has been recommended by the "CSCO Ovarian Cancer Diagnosis and Treatment Guidelines 2022 Edition" to evaluate the treatment of MSI-H/dMMR platinum-sensitive recurrent ovarian epithelial carcinoma that cannot be surgically removed to achieve satisfactory debulking (grade III recommendation).
and treatment of MSI-H/dMMR platinum-resistant recurrent ovarian epithelial carcinoma (grade III recommendation).

In addition, on August 19, 2022, the National Medical Products Administration (NMPA) approved the new "300mg biweekly administration" regimen of envolimab, which is more flexible for doctors to formulate treatment plans and more convenient
for patients to receive treatment compared with the previous "150mg weekly administration" regimen.
As the world's first subcutaneous injection of PD-L1 monoclonal antibody, envolimab provides a new way
of administration for clinical treatment.
Compared with other PD-1/PD-L1 monoclonal antibodies, subcutaneous injection can not only avoid the infusion reaction that may be caused by intravenous administration, but also facilitate the long-term use of immunotherapy and help realize the management
of chronic tumor disease.
It is believed that envolimab can make progress in the treatment of more tumors in the future, and obtain more tumor diagnosis and treatment guidelines, thereby benefiting more tumor patients
.

References:

Shen Lin, Li Jian, Deng Yanhong, et al.
Efficacy and safety of Envafolimab (KN035) monotherapy in the treatment of MSI-H/dMMR advanced solid tumors: data update of single-arm, multicenter phase II.
study[J].
2021 CSCO.