Findings from the CheckMate 649 trial “further support the use of (Opdivo) plus chemotherapy as a tolerable and efficacious first-line treatment” for some patients, according to researchers.
Patients with advanced/metastatic non–human epidermal growth factor receptor 2 (HER2)-positive gastric/gastroesophageal junction cancer (GC/GEJC) or esophageal adenocarcinoma (EAC) and treated with Opdivo (nivolumab) and chemotherapy maintained their health-related quality of life (HRQoL) “with a reduced risk of definitive deterioration in disease-related and overall health status and without increased treatment-related symptom burden” when compared with patients treated with standalone chemotherapy, according to recent study findings.
Those findings, published in the Journal of Clinical Oncology, “can be helpful when counseling patients with advanced or metastatic GE/GEJC or EAC, providing reassurance that the benefits of adding (Opdivo) to chemotherapy extend not only to improved survival, but also to preservation of their quality of life and prolonged symptom control,” wrote Journal of Clinical Oncology associate editor, Dr. Andrew H. Ko, in a contextual commentary published alongside the study.
Analyzing patient-reported outcomes (PROs) from the phase 3 CheckMate 649 trial, researchers assessed 1,581 participants’ HRQoL via the EQ-5D and Functional Assessment of Cancer Therapy-Gastric (FACT-Ga) scales, including the FACT-General (FACT-G) and Gastric Cancer subscale (GaCS), with the FACT-G GP5 item used to assess treatment-related symptom burden, and studied longitudinal changes in HRQoL measured with mixed models for repeated measures in the PRO analysis population of 1,360 randomly assigned patients, researchers detailed, noting that they also conducted time to symptom or definitive deterioration analyses.
Researchers found that patient-reported symptom burden was not increased with Opdivo plus chemotherapy versus chemotherapy alone in the PRO analysis population, and mean improved changes from baseline were greater for patients treated with Opdivo plus chemotherapy versus chemotherapy alone “for FACT-Ga total, GaCS and EQ-5D visual analog scale in patients with a CPS (combined positive score, the measure of the number of PD-L1-positive cells compared with the total number of tumor cells) of (at least) 5; results were similar for the overall PRO analysis population
“In CPS ≥5 and all randomly assigned populations, (Opdivo) plus chemotherapy reduced the risk of symptom deterioration versus chemotherapy, on the basis of FACT-Ga total score and GaCS; time to definitive deterioration was longer, and the risk of definitive deterioration in HRQoL was reduced with (Opdivo) plus chemotherapy across EQ-5D and most FACT-Ga measures.”
These PRO results, when combined with CheckMate 649’s previously reported discovery of Opdivo’s “clinically meaningful efficacy benefit and manageable safety profile, further support the use of (Opdivo) plus chemotherapy as a tolerable and efficacious first-line treatment for patients with advanced or metastatic non–HER2-positive GC/GEJC or EAC,” the study authors wrote.
With more than 2,000 overall participants, CheckMate 649 was launched in 2020 and is expected to be completed in May of 2024, according to its listing on clinicaltrials.gov.
Three-year follow-up data from the trial, presented during the 2023 Gastrointestinal Cancers Symposium, showed that patients’ median overall survival (the time following treatment when a patient is still alive) was 14.4 months when treated with Opdivo plus chemotherapy and 11.1 months when treated with chemotherapy alone among patients with a PD-L1 combined positive score (CPS) of at least five, and that the three-year overall survival rates for the two patient groups were 21% and 10%, respectively.
Among patients in the all-randomized population, Opdivo plus chemotherapy reduced the risk of death by 21% when compared with standalone chemotherapy, with a median overall survival of 13.7 months versus 11.6 months and three-year overall survival rates of 17% and 10%, respectively.
Opdivo is an immune checkpoint inhibitor, a type of targeted immunotherapy which prevents the protein programmed death 1 (PD-1) from binding with the proteins programmed death-ligand 1 and 2 (PD-L1 and PD-L2) allowing PD-1 to let the body’s T cells fight the cancer cells.
The combination of Opdivo and chemotherapy was approved by the Food and Drug Administration in 2021 for the treatment of patients with advanced or metastatic gastric cancer, gastroesophageal junction (GEJ) cancer and esophageal adenocarcinoma. Opdivo was the first front-line immunotherapy agent approved for the treatment of gastric cancer.
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