US-based pharmaceutical giant Bristol-Myers Squibb (BMS, NYSE: BMY) has received two new indication approvals in China for its PD-1 inhibitor Opdivo (nivolumab). The immunotherapy is now approved as adjuvant therapy for patients with pathological residual esophageal cancer or gastroesophageal junction cancer following neoadjuvant chemoradiotherapy (CRT) and complete surgical resection. Additionally, Opdivo is approved for first-line treatment of advanced or metastatic esophageal squamous cell carcinoma (ESCC) in combination with fluoropyrimidine and platinum. These fifth and sixth approvals make Opdivo the first and only PD-1/PD-L1 inhibitor in China for adjuvant therapy and advanced first-line therapy for esophageal cancer, as well as the first to cover first-line gastrointestinal cancer.
Adjuvant Therapy Approval: CheckMate-577 Study
The adjuvant therapy approval is based on the CheckMate-577 study, which showed that Opdivo doubled the median disease-free survival (DFS) of postoperative patients to 22.4 months compared to 10.4 months in the control group. Patients benefited regardless of PD-L1 expression status and histological type. In Chinese patients with high incidence of esophageal squamous cell carcinoma, a greater DFS benefit was observed. The median DFS in the Opdivo group was 29.7 months, compared to 10.6 months in the control group.
First-Line Advanced ESCC Approval: CheckMate-648 Study
The approval for first-line advanced ESCC is based on the CheckMate-648 study. Opdivo combined with chemotherapy significantly improved overall survival (OS) compared to chemotherapy alone, with a median OS of 13.2 months in the Opdivo plus chemotherapy group versus 10.7 months in the chemotherapy-only group. The combination also demonstrated a clinically meaningful improvement in objective response rate (ORR), with an ORR of 47% in the Opdivo group compared to 27% in the chemotherapy-only group. In patients with PD-L1 expression ≥ 1%, Opdivo plus chemotherapy showed a median OS of 15.4 months, more than six months longer than chemotherapy alone (9.1 months), reducing the risk of death by 46%. The ORR was 53% in the Opdivo group, 2.5 times higher than the 20% observed with chemotherapy alone.
Opdivo’s Expanding Indications in China
Since its initial approval in China in June 2018, Opdivo has been approved for multiple indications, including treatment of EGFR mutation-negative and ALK-negative locally advanced or metastatic non-small cell lung cancer (NSCLC) after progression or intolerance to platinum-containing chemotherapy; recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) with PD-L1 expression; advanced or recurrent gastric or gastroesophageal junction adenocarcinoma; and first-line treatment of advanced or metastatic gastric cancer, gastroesophageal junction cancer, or esophageal adenocarcinoma in combination with fluorouracil and platinum-based chemotherapy. These approvals highlight Opdivo’s growing role in addressing significant unmet needs in oncology.-Fineline Info & Tech
