Recently (April 16), FDA approved PD-1 nivolumab (opdivo) of BMS, Bristol-Myers Squibb Co.) for patients with advanced or metastatic gastric cancer, gastroesophageal junction cancer and esophageal adenocarcinoma in combination with first-line chemotherapy, which caused a great sensation in the tumor circle. This approval makes nivolumab the first approved immunotherapy for first-line treatment of gastric cancer.
It is based on a study called CheckMate-649, a randomized, multicenter, open-label phase III clinical study, serving to assess the efficacy of combined chemotherapy with nivolumab in the treatment of advanced or metastatic gastric, gastroesophageal junction or esophageal adenocarcinoma compared to chemotherapy alone. The study only included patients with negative HER2 expression and no previous treatment.
The primary endpoint of such study was the overall survival (OS) and progression free survival (PFS) assessed by BICR of patients with positive PD-L1 expression (CPS≥5) treated with nivolumab (opdivo) combined with chemotherapy compared with chemotherapy alone.
The study involved a total of 2,032 patients, including 208 in the Chinese subgroup. Research findings show that in terms of OS, the median OS of patients with PD-L1 CPS≥5 was 15.5 months in the combined treatment group and 9.6 in the chemotherapy alone group (Fig. a). In patients with PD-L1 CPS≥1, the median OS was 14.3 months in the combined treatment group and 9.9 in the chemotherapy alone group (Fig. b). Among all randomized populations, the OS was 14.3 months in the combined treatment group and 10.3 in the chemotherapy alone group (Fig. c). Among all randomized populations, the combined treatment group proved a clinically significant overall survival benefit.
For progression free survival (PFS) of patients with PD-L1 CPS≥5, the median PFS was 8.5 months in the combined treatment group and 4.3 in the chemotherapy alone group (Fig. a). In patients with PD-L1 CPS≥1, the median PFS was 8.3 months in the combined treatment group and 4.9 in the chemotherapy alone group (Fig. b). Among all randomized populations, the median PFS was 8.3 months in the combined treatment group and 5.6 in the chemotherapy alone group (Fig. c). Among all randomized populations, the combined treatment group proved clinically significant progression PFS benefits.
Nivolumab combined with the first-line chemotherapy treatment of unresectable advanced or metastatic gastric cancer and gastroesophageal junction cancer has garnered clinically significant OS and PFS benefits in the Chinese population, compared with chemotherapy alone. The OS and PFS benefits were observed in patients with positive PD-L1 expression and combined positive score (CPS) ≥5, CPS≥1, and all other randomized populations.
While imported PD-1 McAb opdivo shows impressive curative effect in gastric cancer, domestic PD-1 McAb is also heading its way ahead. Pharmasource, a vertical e-commerce online marketplace serving the pharmaceutical industry, could offer you not only PD-1 McAb but also pharmaceutical laboratory equipments. Please contact us if you are interested in various types of active pharmaceutical ingredients, too. Next, let's take a glance at what combinations can we foresee.
1. Camrelizumab plus Capecitabine and CAPOX and sequential therapy of combined Camrelizumab and Apatinib
The Clinical Cancer Research virtually published the results of first-line treatment of HER2 negative advanced gastric/gastroesophageal junction adenocarcinoma with Camrelizumab plus Capecitabine and CAPOX and sequential therapy of combined Camrelizumab and Apatinib on March 25. This was a national multi-center Phase II clinical trial led by Professor Shen Lin from Beijing Cancer Hospital. It was revealed in the results that the object...
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