Get the qualification of FDA FTD, Envolimu will bring survival benefits to patients with multi -tumors!

*For medical professionals for reading reference

Envoli Mippy not only takes into account the efficacy, safety, and convenience, but also is also expected to become "all -round players"!

Immunotherapy is a major breakthrough in the field of tumors today. It is a new concept and method completely different from traditional treatment methods, bringing new treatment options to the majority of tumor patients. Immune examination point inhibitors represented by PD-1/PD-L1 inhibitors have shown good treatment potential in the field of multi-tumor treatment. Among them, PD-L1 inhibitors independently developed by China-my country's independent developed PD-L1 inhibitors- — Evol Mippitive, because it is the world's first PD-L1 inhibitor that can be administered by subcutaneous injection, can take into account the efficacy and convenience of tumor treatment, which has attracted the attention of tumor doctors and patients.

Not long ago, Envoli Mutterum obtained the qualifications of the Fast Examination and Approval Channel (FTD) for the treatment of first -line/second -tier chemotherapy after the development of first -line/second -line diseases. (UPS)/Fibrous tissue cell sarcoma (MFS). But do you know? Envolimab has already made progress in the field of multiple tumor drug treatment. This article will review the research progress of Endolimura in the field of digestive tract tumors and clinical application practice for readers.

Immunotherapy brings "new vitality" to the digestive tract tumor

my country is a large tumor country, and the incidence of gastrointestinal tumors is also at a high level in my country. According to the latest global cancer data released by the World Health Organization International Cancer Research Agency (IARC), in the top 10 high incidence tumors in my country in 2020, digestion Tao tumors accounted for 4, namely colorectal cancer, gastric cancer, liver cancer, and esophageal cancer. At the same time, data showed that the death rate of cancer in my country was higher, of which 36.4%of cancer -related death came from digestive tract tumors [2].

Because most of the patients in my country are diagnosed, it is advanced when diagnosed, so it is impossible to undergo radical surgical treatment, and the survival benefits of traditional treatment and chemotherapy and other treatment methods are very limited. The poor pessimistic situation, so there is currently a huge uncomfortable demand in the field of gastrointestinal tumors. It is worth noting that in recent years, immunotherapy has shown excellent results in digestive tract tumors, which is expected to become a new choice of patients.

In terms of gastric cancer, Checkmate-649 studies the Chinese Asian group analysis [3], Orient-16 studies [4] proved that compared with simple chemotherapy, immunotherapy combined chemotherapy can bring better effects to patients with advanced gastric cancer in China. In addition, Keynote-811 studies [5] proves that immunotherapy can also bring clinical benefits to Her-2 positive patients. Based on the above studies, immunotherapy is brilliant in the first -line treatment of advanced gastric cancer, and has obtained recommendations from many domestic and foreign guidelines such as the National Comprehensive Cancer Network (NCCN) and the China Clinical Oncology Society (CSCO).

In terms of colorectal cancer, immunotherapy can also be described as blooming more. The emergence of Keynote-177 research [6] makes immunotherapy a "cornerstone" therapy for immune therapy to become highly unstable/mismatch repair defects (MSI-H/DMMR) metastatic colorectal cancer. The CHECKMATE-142 research [7] further made people see the potential of dual-free treatment solutions in MSI-H/DMMR metastatic colorectal cancer. Not only that, in recent years, immunotherapy has also been frequently passed on the treatment of digestive tract tumors such as liver cancer and esophageal cancer. Among them, there is a special drug worth looking forward to. It is the PD-L1 inhibitor independently developed by my country-Endovari Mipide.

Safety! efficient! Convenience! Envoli Mupage has become a new selection of various digestive tract tumors

Compared with conventional PD-1/PD-L1 inhibitors, Envoli Mipide has a unique advantage. It maintains the advantages of high efficacy and good safety of PD-L1 antibody drugs, and has small molecular weight, high affinity, stability, stability Good and convenient characteristics of subcutaneous injection.

Earlier, KN035-US-001 Study [8], KN035-JP-001 Studies [9] and KN035-CN-001 Study [10] Three-stage clinical studies were conducted in the United States, Japan, and China. The safety and feasibility of patients with the treatment of advanced physical tumors in the treatment of late -stage drugs. The above studies have shown that Evol's single anti -skin injection has good tolerance and lasting anti -tumor activity.

The KN035-CN-006 study led by Chinese scholars [11] further showed that Evolipab showed good curative effects and safety among patients with advanced MSI-H/DMMR physical tumors. This study is a multi -centered and phase II clinical study, with a total of 103 subjects, including 65 patients with colorectal cancer, 18 patients with advanced gastric cancer, and 20 patients with advanced physical tumors.

The results of the study show that the objective relief rate (ORR) of the OK (ORR) of the Blind Independence Evaluation Committee (BIRC) evaluation (ORR) is 43.1%, 55.6%, 40.0%, and 44.7 among advanced colorectal cancer, ORR). %; As of data analysis, patients with advanced colorectal cancer, advanced gastric cancer, other physical tumors, and all population were 89.3%, 100%, 100%, and 93.2%of patients. ) The rates were 72.0%, 77.4%, 75.0%, and 73.6%. A total of 18 patients (17.5%) occurred in a total of 3-4 drug-related treatment (Trape), and no level 5 TRAE occurred. Based on the KN035-CN-006 study, Envoli Mipide has been recommended by the "CSCO Gastric Cancer Diagnosis and Treatment Guide 2022", respectively. Status) Patients with advanced gastric cancer (grade I, class 2A evidence); "CSCO colorectal cancer diagnosis and treatment Guidelines 2022" recommendation for palliative second-line, third-line MSI-H/DMMR patients (class II recommendation, class 2A evidence); "" Class 2A evidence); "Class 2A evidence); CSCO Immune Examination Point Inhibitors Clinical Application Guide 2022 "is recommended for MSI-H/DMMR advanced physical tumor second-line treatment (grade I recommendation, class 2A evidence).

In addition, on August 19 this year, the State Drug Administration (NMPA) also approved the new "300mg administration every two weeks" medication solution for Ervoli Meticuke, which was "once a week" by "150mg once a week". Compared with the scheme, while maintaining similar pharmacokinetics, safety, and effective characteristics, it is more flexible when doctors formulate treatment plans, and patients are more convenient when receiving treatment.

The stage of Envolimab is far more than the digestive tract tumor!

It can be seen that Envoli Metico shows a good curative effect on the MSI-H/DMMR colorectal cancer and gastric cancer. It is basically the same as most PD-1 inhibitors and has good safety The "surprise" brought to us by Li Zhi is far more than that.

The 2020 American Society of Clinical Oncology (ASCO) Annual Meeting reported the KN035-CN-007 study conducted by Chinese scholars [12]. The safety of the first -line treatment of adenocarcinoma patients and the preliminary efficacy of phase II, one -arm, and open multi -center research. The study showed that among the 15 patients with evaluation, ORR was 60%, the median DOR did not reach, the median PFS was 6.8 months, and the incidence of 3-4 TEAE was 73.3%.

This year's CSCO Annual Meeting, Professor Shen Lin of Peking University Cancer Hospital, Professor Xu Jianming, Professor Xu Jianming, First Medical Center of the General Hospital of the PLA, will also introduce us to the latest research progress related to Envolimaguy. In addition, a phase III clinical study that explores the efficacy and safety of patients with the first -line treatment of Envolitab combined with Gisbinbin and Osarbin Phase III.

Not only that, researchers have also explored the efficacy of Envolipumu in the field of non -digestive tumor treatment in non -small cell lung cancer, endometrial cancer, urinary tract skin and other non -digestive tumors. This time, Envolimab's treatment of soft tissue sarcoma for the treatment of FTD was obtained by the FTD qualification of FDA, which is based on ENVASARC research [13] data. In the future, Envolitab is expected to become a PD-L1 inhibitor applied in more tumors, and will benefit more tumor patients.

references

[1] https://gco.ik.fr/

[2] Wang Yilei, Peng Xinguo. The detection application and research status of tumor markers during the diagnosis of digestive tract tumors [J]. Test medicine and clinical, 2021,18 (05): 700-701+710.

[3] Liu T, Bai Y, Lin X, et al. First-line nivolumab plus chemotherapy vs chemotherapy in patients with advanced gastric, gastroesophageal junction, and esophageal adenocarcinoma: CheckMate 649 Chinese subgroup analysis[J]. Int J Cancer. 2022 , 19.

[4] Xu JM, Jiang HP, Pan YY, et al. Sintilimab plus chemotherapy (chemo) versus chemo as the first-line treatment for advanced gastric or gastroesophageal junction (G/GEJ) adenocarcinoma (ORIENT-16). 2021 ESMO, Abstract LBA53.[5] Janjigian YY, Kawazoe A, Yañez P, et al. The KEYNOTE-811 trial of dual PD-1 and HER2 blockade in HER2-positive gastric cancer[J]. Nature. 2021, 600(7890): 727-730.

[6] Diaz LA Jr, Shiu KK, Kim TW, et al. Pembrolizumab versus chemotherapy for microsatellite instability-high or mismatch repair-deficient metastatic colorectal cancer (KEYNOTE-177): final analysis of a randomised, open-label, phase 3 Study [j]. Lancet Oncol. 2022, 23 (5): 659-670.

[7] Michael J. Overman, Heinz-Josef Lenz, Thierry Andre, et al. Nivolumab (NIVO) ± ipilimumab (IPI) in patients (pts) with microsatellite instability-high/mismatch repair-deficient (MSI-H/dMMR) Metastatic Colretal Cancer (MCRC): Five-year Follow-up from Checkmate 142. 2022 ASCO. Abstract 3510.

[8] K.P. Papadopoulos, W. Harb, N. Lu, Phase I Study of KN035, a novel fusion Anti-PD-L1 Antibody administered subcutaneously in Patients with Advanced Solid Tumors in the USA. 2018 ESMO, Abstract 1456.

[9] Toshio Shimizu , Takako Eguchi Nakajima, Ni Lu, et al. Phase I Safety and Pharmacokinetic Study of KN035, the first subcutaneously administered, novel fusion Anti-PD-L1 Antibody in Japanese Patients with Advanced Solid Tumors. 2019 ASCO, Abstract 2609.

[10] Jian-Ming Xu, Shukui Qin, Yun Zhang, et al. Phase I study of KN035, the first subcutaneously administered, novel fusion anti-PD-L1 antibody in patients with advanced solid tumors in China. 2019 ASCO, Abstract 2608 Then, then, then

[11] Shen Lin, Li Jian, Deng Yanhong, etc.CSCO. [12] Yin XL, ZHANG Y, DENG YENG YH, et al. ENVAFOLIMAB PLUS Chemotherapy in Advanced Gastroesopal Junction (G/Gej) CANCER. 2020 Asco, ABSTRACT E1658585.

Chemotherapy. 2021 AACR, Abstract CT239.

*This article is only used to provide scientific information to medical people, and does not represent the viewpoint of this platform

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