The results of the first phase 3 study of the first-line immunotherapy for gastric cancer in China are announced, which is expected to revolutionize the treatment landscape

▎ WuXi AppTec's content team reported that on April 10, Bristol-Myers Squibb (BMS) announced the main results of the key phase 3 study of the CheckMate-649 China subgroup.

The results show that in the Chinese population, compared with chemotherapy alone, Odivo (Navulimab) combined with chemotherapy has achieved clinically significant results in the first-line treatment of unresectable advanced or metastatic gastric cancer and gastroesophageal junction cancer.
Survival (OS) and progression-free survival (PFS) benefit.

Regardless of whether PD-L1 expression is positive and the combined positive score (CPS) ≥ 5, CPS ≥ 1, or all random populations, OS and PFS benefit are observed.

The above subgroup analysis results are consistent with the results of the overall population of advanced gastric cancer, gastroesophageal junction cancer and esophageal adenocarcinoma in the CheckMate-649 study.

"The incidence and mortality of gastric cancer in China accounted for 44% and 49% of the world's total, and about 80% of patients were already in the advanced stage at the time of diagnosis.
The
first-line treatment of gastric cancer is a key factor in determining the survival benefit and subsequent treatment of patients.
The first-line standard chemotherapy can bring very limited survival benefits to patients, and innovative treatment options are urgently needed in the clinic.

" Professor Lin Shen, the main researcher of CheckMate-649 in China and the deputy dean of Peking University Cancer Hospital, said, "Chinese patients are urgently Clinical demand is one of the biggest driving forces for the development of advanced gastric cancer treatments in the world.

The Chinese subgroup data of the CheckMate-649 study strengthens our confidence in promoting the continuous development of gastric cancer and gastroesophageal junction cancer immunotherapy, and is expected to comprehensively revolutionize advanced gastric cancer in China And the pattern of first-line treatment for gastroesophageal junction cancer.

"The Bristol-Myers Squibb Company press release pointed out that in the clinical study of immunotherapy for gastric cancer and gastroesophageal junction cancer covering patients in mainland China, the CheckMate-649 study is the first and currently the only phase 3 study of first-line treatment with positive results.
Enrolled 208 previously untreated and inoperable HER2-negative patients with advanced or metastatic gastric cancer or gastroesophageal junction cancer in Mainland China, and were randomly assigned to the nivolumab combined chemotherapy group or the chemotherapy group alone.

Regardless of PD-L1 expression ,
Can be included in the group.
As a PD-1 inhibitor directly involved in the development of Nobel Prize winners in Physiology or Medicine, Odivo has been approved in July 2014 as the world’s first PD-1 immunotherapy.
More than ten cancer indications have been approved worldwide, covering lung cancer, head and neck cancer, stomach cancer, esophageal cancer, liver cancer, kidney cancer, colorectal cancer, urothelial cancer, melanoma, Hodgkin's lymphoma, pleural tumors, etc.

In China Odivo is also the first immuno-oncology drug approved.
It has been approved for indications such as non-small cell lung cancer, head and neck squamous cell carcinoma, and gastric or gastroesophageal junction adenocarcinoma.

CheckMate-649 is a product.
A phase 3 randomized, multi-center, open-label clinical study designed to evaluate the use of nivoliumab combined with chemotherapy or nivoliumab combined with ipilimumab in the treatment of previously untreated patients compared with chemotherapy alone Efficacy of HER2-negative, advanced or metastatic gastric cancer, gastroesophageal junction cancer, or esophageal adenocarcinoma.
The
primary end point of the study is compared with chemotherapy alone, nivolumab combined with chemotherapy for PD-L1 positive expression means a combined positive score (CPS) OS in patients ≥5, and PFS based on the blinded Independent Central Review Committee (BICR) assessment.
The
results of the study showed that in patients with PD-L1 positive and CPS ≥5, the main endpoint of the study, Odivo combined The median OS of the chemotherapy group was 15.
5 months, and the control chemotherapy alone group was 9.
6 months.

The median PFS of the Odivo combined chemotherapy group was 8.
5 months, and the chemotherapy alone group was 4.
3 months.

In addition, the secondary study endpoints The objective response rate (ORR) of the Odivo combined chemotherapy group was 68%, and the chemotherapy group alone was 48%.

In PD-L1 positive patients with CPS≥1 and all randomized populations, Odivo combined chemotherapy also showed clinically significant OS benefits.

Among patients with PD-L1 positive and CPS≥1, the median OS of the Odivo combined chemotherapy group was 14.
3 months, and that of the chemotherapy alone group was 9.
9 months.

In all randomized populations, the median OS of Odivo combined with chemotherapy was 14.
3 months, and that of chemotherapy alone was 10.
3 months.

In this study, the safety characteristics of Odivo combined with chemotherapy are consistent with the known safety characteristics of Odivo and chemotherapy, and no new safety signals have been observed.

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

Picture source: 123RF public information shows that in 2020, approximately 1.
09 million new cases of gastric cancer and 768,000 deaths are expected worldwide.

In China, the number of new incidences and deaths of gastric cancer ranks the top three among all cancers, accounting for 44% and 49% of the global incidences and deaths of gastric cancer, respectively.

The definition of gastric cancer is broad.
A variety of cancers, including gastroesophageal junction (GEJ) cancer formed at the junction of the stomach and esophagus, can be classified as gastric cancer.

Because many patients with gastric cancer cannot tolerate follow-up treatment due to their worsening condition, first-line treatment is often the best opportunity for patients with gastric or gastroesophageal junction cancer to achieve curative effect.

There will be approximately 604,000 new cases of esophageal cancer worldwide in 2020, and the death toll will exceed 544,000.

Squamous cell carcinoma (ESCC) and adenocarcinoma are still the two most common types, accounting for nearly 90% and 10% of the total number of esophageal cancer patients, respectively.
The composition of different tissue types varies greatly between regions.

Most ESCC cases are concentrated in Asia, accounting for about 80% of ESCC cases worldwide in 2020.

Most patients with esophageal cancer are already at an advanced stage when they are diagnosed.

Professor Xu Ruihua, a Chinese researcher of CheckMate-649 and dean of Sun Yat-sen University Cancer Center, pointed out: "Gastric 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 the first-line treatment of Chinese gastric cancer and gastroesophageal junction cancer patients, and this conclusion is based on considerable China The population size provides abundant evidence-based medical evidence for the clinical treatment and academic research of gastric cancer in China, which 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 diagnosis and treatment of gastric cancer in China.

"Under the premise of fully considering the high incidence of gastric cancer in China, the CheckMate-649 study included large-scale Chinese patients who are representative of first-line gastric cancer, and adopted a strategy that is highly compatible with the current clinical practice of gastric cancer in China.
The clinical research and treatment of gastric cancer in China Landmark.

"Bristol-Myers Squibb Global R&D Vice President and Head of China R&D, Dr.
Cai Xuejun said, "In the first-line treatment of HER2-negative gastric cancer and gastroesophageal junction cancer, Odivo combined chemotherapy is the first and currently only treatment in more than ten years.
Phase 3 clinical trials have confirmed a treatment plan that can surpass chemotherapy and bring significant survival benefits to patients.

We hope to bring this breakthrough clinically valuable treatment option to more Chinese patients as soon as possible, and solve their urgent and unmet need for treatment.

"I look forward to more good news from Odivo’s related research and benefit more patients.

Read about the precise treatment of advanced gastric cancer.
What new targets and new therapies are there? The sub-publish of Nature draws a blueprint for ASCO's anti-cancer progress in 2020 : Accurate treatment of gastrointestinal cancer and lung cancer shines brightly, multiple combination therapies prolong survival "The Lancet-Oncology": A new choice for the first-line treatment of advanced gastric cancer in Asians? TAS-118 combined with oxaliplatin is better than standard plan reference Data [1] The results of the first phase III study of the first-line immunotherapy for gastric cancer in China were announced.
Retrieved Apr 10, 2021, from Bristol-Myers Squibb Press Release Note: This article aims to introduce the progress of medical and health research, not a treatment plan recommendation.

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