Bristol Myers Squibb announced that their phase 3 CheckMate-649 trial demonstrated superior overall survival and profession-free survival using nivolumab plus chemotherapy to treat patients with gastric and esophageal cancers.
The phase 3 CheckMate-649 trial evaluating nivolumab (Opdivo) plus chemotherapy compared to chemotherapy alone as a first-line treatment of gastric and esophageal cancers met its primary endpoints of overall survival (OS) and progression-free survival (PFS), according to a Bristol Myers Squibb press release.
Nivolumab is the first PD-1 inhibitor to demonstrate a superior OS and PFS rate when combined with chemotherapy compared to chemotherapy alone for patients with metastatic gastric cancer, gastroesophageal junction (GEJ) cancer or esophageal adenocarcinoma.
“There is an urgent need to improve therapeutic options for patients with esophageal and stomach cancer,” Yelena Y. Janjigian, MD, Principal Investigator, chief of Gastrointestinal Oncology for Memorial Sloan Kettering Cancer Center, said in a press release. “Responses to the current standard chemotherapy in patients are short lived, and less than 6% of patients with metastatic disease survive beyond five years.”
In the phase 3 randomized, multi-center, open-label study, patients in both the nivolumab plus chemotherapy arm and chemotherapy alone arm continued treatment for 2 years or until disease progression, unacceptable toxicity or withdrawal of consent. Secondary endpoints of the trial included OS in combined positive score ≥ 1 and all randomized patients treated with nivolumab plus chemotherapy.
The safety profile of this combination is reflective of the known safety profiles for both nivolumab and chemotherapy in first-line gastric and esophageal cancers.
Janjigian continued to say that the results from the CheckMate-649 trial represent a new opportunity to “improve survival for patients beyond standard chemotherapy.”
Bristol Myers Squibb plans to complete a full evaluation of the available data from the CheckMate-649 trial. More, the company is working to share the results at an upcoming medical conference as well as with health authorities.
“The results from CheckMate-649, the largest study of gastric and esophageal cancers conducted to date, indicate the potential for Opdivo plus chemotherapy to change practice in the first-line setting and become a new standard of care for certain patients with gastric cancer, gastroesophageal junction cancer or esophageal adenocarcinoma,” Ian M. Waxman, MD, development lead for Gastrointestinal Cancers at Bristol Myers Squibb, said in a press release.
Gastric cancer is the fifth most common type of cancer and the third leading cause of cancer deaths worldwide. For patients with metastatic disease in the United States, the 5-year relative survival rate is 5.5%. First-line treatment for patients with gastric or GEJ cancer provides the best chance for efficacy.
For esophageal cancer, this type is the seventh most common cancer and fifth leading cause of cancer deaths worldwide. The 5-year relative survival rate for patients with metastatic disease in the United States is 4.9%. The most common type of esophageal cancer is squamous cell carcinoma, accounting for 85% of all esophageal cancer cases.
“We look forward to engaging health authorities worldwide with the goal of bringing this immunotherapy-based treatment option to patients as soon as possible,” said Waxman.
CheckMate -649, a Phase 3 Trial Evaluating Opdivo (nivolumab) Plus Chemotherapy vs. Chemotherapy, Meets Primary Endpoints Demonstrating Superior Overall Survival and Progression-Free Survival in First-Line Treatment of Gastric and Esophageal Cancers [news release]. Princeton, New Jersey. Published August 11, 2020. https://news.bms.com/press-release/corporatefinancial-news/checkmate-649-phase-3-trial-evaluating-opdivo-nivolumab-plus-c. Accessed August 11, 2020.