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    Home > Active Ingredient News > Digestive System Information > ​OS is over 1.5 times, PFS has nearly doubled!

    ​OS is over 1.5 times, PFS has nearly doubled!

    • Last Update: 2021-04-24
    • Source: Internet
    • Author: User
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    *Only for medical professionals to read for reference.
    Last Saturday night, the results of the first phase III study of the first-line immunotherapy for gastric cancer in the Chinese subgroup were stunning at the American Association for Cancer Research (AACR) annual meeting.

    The results of the Chinese subgroup of the CheckMate-649 study confirmed that drug O (Odivo, nivolumab) combined with chemotherapy for advanced Chinese patients achieved clinically significant overall survival (OS) and progression-free survival (PFS) ) Benefits, and a higher objective response rate (ORR), this result is consistent with the results of the overall population of advanced gastric cancer, gastroesophageal junction cancer and esophageal adenocarcinoma in the study.

    Just two days before the release of this data, CheckMate-649’s sister study, CheckMate-648, also released preliminary positive results: O drug combined with chemotherapy, first-line treatment of patients with esophageal squamous cell carcinoma, OS and PFS significantly benefited; immune twins Star O drug combined with Y drug (Ipilimumab), the first-line treatment of patients with esophageal squamous cell carcinoma, OS has a significant benefit.

    Based on the results of these two studies, O drug has become the world's first and currently the only one in the field of upper gastrointestinal tumors (including gastric cancer, gastroesophageal junction cancer, esophageal adenocarcinoma, and esophageal squamous cell carcinoma) to achieve first-line full coverage of immunity Tumor treatment drugs.

     CheckMate-649 Chinese subgroup results: OS and PFS have a beautiful survival benefit curve! ORR is higher! China is a country with a high incidence of gastric cancer, and most patients are diagnosed in an advanced stage.

    Due to insufficient treatment of advanced gastric cancer, the 5-year survival rate for patients with metastatic gastric cancer is only 9.
    4%.

    Therefore, there is an urgent need for innovative treatments in the clinic.

    In a clinical study of immunotherapy for gastric cancer and gastroesophageal junction cancer covering patients in mainland China, CheckMate-649 is the first and currently the only first-line phase III study that has achieved positive results.

    The study included a total of 208 previously untreated and inoperable HER2-negative patients with advanced or metastatic gastric cancer or gastroesophageal junction cancer in mainland China, and adopted a strategy that is highly compatible with the current clinical practice of gastric cancer in China, and clinical research and treatment of gastric cancer in China Landmark.

    The results of the Chinese subgroup of the CheckMate-649 study showed that compared with chemotherapy alone, nivolumab combined with chemotherapy in the first-line treatment of unresectable advanced or metastatic gastric cancer and gastroesophageal junction cancer achieved clinically significant OS and PFS gains.
    Benefits; regardless of whether PD-L1 expression is positive and combined positive score (CPS) ≥ 5, CPS ≥ 1, or all random populations, OS and PFS benefits are observed; in patients with PD-L1 positive and CPS ≥ 5 It was observed that the median overall survival and median progression-free survival benefits of the nivolumab combined with chemotherapy group were more than 1.
    5 times and nearly twice that of the chemotherapy group alone.

    For this result, the main researcher of CheckMate-649 in China, Professor Lin Shen, deputy dean of Peking University Cancer Hospital, fully affirmed: "The incidence and mortality of gastric cancer in China accounted for 44% and 49% of the global total, and about 80%.
    % Of patients are already in advanced stage at diagnosis.

    First-line treatment of gastric cancer is a key factor in determining the survival benefit and subsequent treatment of patients.
    However, in the past, standard first-line chemotherapy can bring very limited survival benefits to patients, and innovative treatment options are urgently needed in the clinic .

    clinical needs of patients in China is one of the biggest driving force for the development of advanced gastric cancer in the world.

    China subgroup data CheckMate-649 study strengthened our confidence and promote gastric cancer immunotherapy gastroesophageal junction growing, and is expected to fully Revolutionize the pattern of first-line treatment for advanced gastric cancer and gastroesophageal junction cancer in China.

    "In patients with PD-L1 positive and CPS ≥ 5: The OS of the nivoliumab + chemotherapy group was 1.
    5 times that of the chemotherapy alone group.
    The median OS of the nivoliumab + chemotherapy group was 15.
    5 months (95%).
    CI: 11.
    9-25.
    5), the control chemotherapy alone group was 9.
    6 months (95% CI: 8.
    0-12.
    1) (HR: 0.
    54; 95% CI: 0.
    36-0.
    79); the PFS of the nivolumab + chemotherapy group reached The median PFS of the chemotherapy alone group was nearly twice that of nivolumab + chemotherapy group was 8.
    5 months (95% CI: 5.
    9-12.
    4), and the chemotherapy alone group was 4.
    3 months (95% CI: 4.
    1-6.
    5) (HR : 0.
    52; 95% CI: 0.
    34-0.
    77); the ORR of the nivolumab + chemotherapy group compared with the chemotherapy group alone, the ORR of the nivolumab + chemotherapy group was significantly increased, the ORR of the nivolumab + chemotherapy group was 68% (95% CI: 56-79) The chemotherapy alone group was 48% (95% CI: 36-60).

    In PD-L1 positive patients with CPS ≥ 1 and all random populations: nivolumab + chemotherapy also showed clinically significant OS gains Benefits Among patients with CPS ≥ 1, the median OS (HR: 0.
    62; 95% CI: 0.
    43-0.
    87) in the nivolumab + chemotherapy group was 14.
    3 months (95% CI: 11.
    5–17.
    5), chemotherapy alone group It was 9.
    9 months (95% CI: 8.
    1–12.
    1); among all randomized populations, the median OS (HR: 0.
    61; 95% CI: 0.
    44-0.
    85) in the nivolumab + chemotherapy group was 14.
    3 months ( 95% CI: 11.
    5–17.
    5), and the chemotherapy alone group was 10.
    3 months (95% CI: 8.
    1–12.
    1).

    In this study, the safety characteristics of nivolumab plus chemotherapy are similar to those of known nivolumab The safety characteristics of anti-chemotherapy and chemotherapy are consistent, and no new safety signals have been observed.

    And the safety of the Chinese subgroup of patients is generally consistent with the global population.

    Professor Xu Ruihua, a Chinese investigator of CheckMate-649 and dean of the Sun Yat-sen University Cancer Center, commented on the study He spoke highly of: "Stomach cancer is one of the most important public health issues in China.

    Accumulating Chinese data, reflecting the Chinese voice, and exploring innovative treatments suitable for Chinese patients are important links in the development of clinical research.

    The Chinese subgroup data of the CheckMate-649 study, for the first time, clarified that immune checkpoint inhibitors combined with chemotherapy can bring significant survival benefits to Chinese gastric cancer and gastroesophageal junction cancer first-line patients, and this conclusion is based on the considerable Chinese population size Above, it provides abundant evidence-based medical evidence for the clinical treatment and academic research of gastric cancer in China.

    It is expected to become an important reference for the formulation of China's diagnosis and treatment guidelines in the future, and promote the development of the overall level of diagnosis and treatment of gastric cancer in China.

    "CheckMate-649 Chinese subgroup data overview compiled from 2021 AACR POSTER CT184 CheckMate-648 preliminary results: "Stomach" immune king attacked the front line of esophageal cancer, won the "elimination" battle Based on the research results of CheckMate-649, nivolumab Combination chemotherapy has become the first and currently the only treatment program that has been proven to surpass chemotherapy and bring significant survival benefits to patients in the first-line treatment of HER2-negative gastric cancer and gastroesophageal junction cancer for more than ten years.

    O drug was also named the "king of stomach immunity".

    And CheckMate-649's sister research CheckMate-648 allowed the king of "gastric immunity" to advance again, and after the first line of gastric cancer, it won the first line of esophageal cancer.
    , Leading the development of immunotherapy for gastrointestinal tumors.

    Based on the preliminary results of the Phase III clinical study CheckMate-648 announced last week, nivolumab combined with ipilimumab (immune gemini), and nivolumab Combination chemotherapy has been proven to bring significant survival benefits for patients with advanced unresectable or metastatic esophageal squamous cell carcinoma (ESCC).

    In a pre-set interim analysis, nivolumab combined with chemotherapy was the primary endpoint-tumor The overall survival (OS) and secondary endpoints of PD-L1 positive populations-all random populations showed statistical differences and clinical benefits in OS.

    In addition, the nivolumumab combined with ipilimumab also reached the primary and secondary study endpoints at the same time.
    The PD-L1 positive tumor patients and all random populations showed statistical differences and clinical significance.
    Improved overall survival.

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