NICE Recommends Nivolumab/Chemo for HER2- Advanced Stomach and Esophageal Cancer

The United Kingdom’s National Institute for Health and Care Excellence (NICE) has issued final guidance recommending the use of nivolumab (Opdivo) plus chemotherapy as a treatment option for patients with HER2-negative advanced stomach and esophageal cancer.¹

The combination regimen resulted in improved progression-free survival and overall survival compared with chemotherapy alone in previously untreated patients with PD-L1–positive advanced or metastatic gastric cancer, gastroesophageal junction (GEJ) cancer, and esophageal adenocarcinoma in the phase 3 CheckMate-649 trial (NCT02872116).

At a minimum follow-up of 12 months, nivolumab plus chemotherapy led to a median overall survival (OS) of 14.4 months (95% CI, 13.1-16.2) compared with 11.1 months with chemotherapy alone (95% CI, 10-12.1) in patients with a PD-L1 combined positive score (CPS) of 5 or greater (HR, 0.71; 98.4% CI, 0.59-0.86; P < .0001); this translated to a 29% reduction in the risk of death with the nivolumab combination.² Moreover, nivolumab plus chemotherapy also resulted in a 32% reduction in the risk of disease progression or death compared with chemotherapy alone (HR, 0.68; 95% CI, 0.56-0.81; P < .0001).

“We’re pleased that NICE has recommended nivolumab plus chemotherapy as an alternative first-line treatment for adult patients with advanced or metastatic stomach, gastroesophageal junction (GEJ) or esophageal cancer whose tumors express PD-L1 with a CPS of 5 or more,” Scott Cooke, general manager, UK and Ireland at BMS, said in a press release.

Patients with stomach and esophageal cancer represent a population with high unmet need, often experiencing poor prognosis and impaired quality of life. In the UK alone, approximately 9,300 patients will receive a diagnosis of esophageal cancer and around 6,500 will receive a diagnosis of gastric cancer every year.

On April 16, 2021, the FDA approved nivolumab plus chemotherapy for the frontline treatment of patients with advanced or metastatic gastric cancer, GEJ cancer, and esophageal adenocarcinoma, marking the first PD-1 inhibitor to receive approval in the United States in gastric cancer.³

“[NICE's recommendation] demonstrates the potential of nivolumab-based combinations to improve survival expectations for patients with hard-to-treat cancers,” Cooke added. “We are grateful to all those involved in the clinical trial and NICE submission process, who have made it possible for us to offer an alternative treatment option to those who need it.”

“A diagnosis of advanced stomach, GEJ or esophageal cancer is devastating for patients, many of whom would not have experienced or noticed symptoms until their cancer was already at an advanced, hard-to-treat stage,” said Julie Harrington, chief executive officer of Guts UK. “It is crucial that more treatments are made available for patients with advanced forms of these cancers, which is why we are delighted by NICE’s decision to recommend nivolumab plus chemotherapy as a first-line treatment option.”

References

1. Bristol Myers Squibb immunotherapy-chemo combination gets NICE recommendation. News release. Bristol Myers Squibb. November 25, 2022. Accessed November 29, 2022. https://bit.ly/3FaETFV
2. Moehler M. Shitara K, Garrido M, et al. Nivolumab (NIVO) plus chemotherapy (chemo) versus chemo as first-line (1L) treatment for advanced gastric cancer/gastroesophageal junction cancer (GC/GEJC)/esophageal adenocarcinoma (EAC): first results of the CheckMate 649 study. Ann Oncol. 2020;31(4):S1191. doi:10.1016/j.annonc.2020.08.2296
3. FDA approves first immunotherapy for initial treatment of gastric cancer. News release. FDA. April 16, 2021. Accessed November 29, 2022. https://bit.ly/3tqsjKA