Bristol Myers Squibb Receives EU Approval for Opdivo as First Immunotherapy for Esophageal Squamous Cell Carcinoma
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On November 24, Bristol-Myers Squibb (BMS) announced that the European Commission (EC) has approved Opdivo (nivolumab) for the treatment of adult patients with unresectable, advanced, recurrent, or metastatic esophageal squamous cell carcinoma (ESCC) who have previously received fluoropyrimidine- and platinum-based combination chemotherapy.
This approval makes Opdivo the first immunotherapy approved in the European Union for the treatment of a type of gastroesophageal cancer. In addition to this EU approval, Opdivo has been approved in five countries, including the United States and Japan, for second-line treatment of patients with unresectable advanced, recurrent, or metastatic esophageal squamous cell carcinoma (ESCC).
This approval is based on the results of the Phase 3 ATTRACTION-3 trial. Sponsored by Ono Pharmaceutical, a Japanese pharmaceutical company, the trial demonstrated that Opdivo treatment resulted in statistically significant and clinically meaningful improvements in overall survival (OS) compared with the chemotherapy group. In this study, Opdivo exhibited a favorable safety profile, consistent with previously reported findings from studies of Opdivo in other solid tumors.
ATTRACTION-3 (ONO-4538-24/CA209-473; NCT02569242) was a Phase 3, multicenter, randomized, open-label, global study comparing Opdivo with chemotherapy (docetaxel or paclitaxel) in patients with esophageal cancer who were refractory to or intolerant of first-line combination therapy (fluoropyrimidine plus platinum). Patient enrollment primarily occurred in Asia, with the remainder in the United States and Europe. In the study, patients continued treatment until disease progression or unacceptable toxicity. The primary endpoint was overall survival (OS). Secondary endpoints included objective response rate (ORR), progression-free survival (PFS), disease control rate (DCR), duration of response (DOR), and safety, as assessed by the investigators.
The results showed that the study met its primary endpoint of overall survival (OS): compared with chemotherapy, Opdivo reduced the risk of death by 23% (HR=0.77, 95% CI: 0.62-0.96; p=0.019). The median OS was 10.9 months (95% CI: 9.2-13.3) in the Opdivo group versus 8.4 months (95% CI: 7.2-9.9) in the chemotherapy group, demonstrating a 2.5-month improvement.
The 12-month and 18-month overall survival (OS) rates in the Opdivo group were 47% (95% CI: 40–54) and 31% (95% CI: 24–37), respectively, compared with 34% (95% CI: 28–41) and 21% (95% CI: 15–27) in the chemotherapy group. A survival benefit with Opdivo was observed regardless of tumor PD-L1 expression level.
The ORR in the Opdivo group and the chemotherapy group was 19% (95% CI: 14–26) and 22% (95% CI: 15–29), respectively. The median DOR was significantly prolonged in the Opdivo group at 6.9 months (95% CI: 5.4–11.1), compared with 3.9 months (95% CI: 2.8–4.2) in the chemotherapy group.
An exploratory analysis of patient-reported outcomes demonstrated a significant improvement in quality of life with Opdivo compared to chemotherapy. Opdivo was associated with fewer treatment-related adverse events (TRAEs) than chemotherapy. The incidence of TRAEs of any grade was 66% in the Opdivo group versus 95% in the chemotherapy group. The incidence of Grade 3 or 4 TRAEs was also lower in the Opdivo group compared to the chemotherapy group (18% vs. 63%). The proportion of patients who discontinued treatment due to TRAEs was identical in both groups (9%).
Reference Source: Bristol Myers Squibb Receives European Commission Approval for Opdivo (nivolumab) as Second-Line Treatment for Unresectable Advanced, Recurrent or Metastatic Esophageal Squamous Cell Carcinoma
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