Opdivo Demonstrates Significant Overall Survival Benefit in First-Line Treatment of Esophageal Squamous Cell Carcinoma, Either Combined with Chemotherapy or Ipilimumab, According to CheckMate -648 Trial

SHANGHAI, June 4, 2021 /PRNewswire/ -- Bristol-Myers Squibb today announced the results of the Phase III clinical trial CheckMate -648. The study includedOpdivotwo combination therapies based on. Results demonstrated that, in the pre-specified interim analysis, compared with chemotherapy,Opdivo (Nivolumab)Combination chemotherapy andOpdivo®CombinationIpilimumabFor patients with advanced unresectable or metastatic esophageal squamous cell carcinoma (ESCC), a statistically significant and clinically meaningful overall survival (OS) benefit was demonstrated in both the tumor PD-L1-positive population and the all-randomized population.OpdivoCombination`Ipilimumab`YesFirstDual immunotherapy proven to improve survival benefit in the aforementioned patients and superior to chemotherapy.

Regarding the primary endpoint, in the PD-L1-positive patient population,OpdivoThe median OS was 15.4 months in the combination chemotherapy group and 9.1 months in the chemotherapy group (hazard ratio [HR] = 0.54; 99.5% confidence interval [CI]: 0.37, 0.80, p < 0.0001). Regarding secondary study endpoints, in the overall randomized population,`Opdivo`The median OS was 13.2 months in the combination chemotherapy group versus 10.7 months in the chemotherapy group (HR = 0.74, 99.1% CI: 0.58–0.96, p = 0.0021). Furthermore, per blinded independent central review (BICR), in the PD-L1-positive population,OpdivoThe combination chemotherapy group demonstrated a statistically significant progression-free survival (PFS) benefit.OpdivoThe median PFS was 6.9 months in the combination chemotherapy group compared with 4.4 months in the chemotherapy-alone group (HR=0.65, 98.5% CI: 0.46, 0.92, p=0.0023).

Regarding another primary endpoint, in PD-L1-positive patients,OpdivoCombinationIpilimumab groupmedian OS was 13.7 months, versus 9.1 months in the chemotherapy group (HR = 0.64; 98.6% CI: 0.46, 0.90; P = 0.001). Regarding secondary endpoints, in the overall randomized population,OpdivoCombination`Ipilimumab`The median OS in the group was 12.8 months, compared with 10.7 months in the chemotherapy group (HR = 0.78, 98.2% CI: 0.62, 0.98, p = 0.011). In the PD-L1-positive patient population,OpdivoCombinationIpilimumabThe group did not meet the other primary study endpoint, BICR-assessed PFS (4.0 months vs. 4.4 months; HR=1.02, 98.5% CI: 0.73, 1.43, p=0.8958).

Opdivo®Combination Chemotherapy andOpdivoCombinationIpilimumabThe safety profile is consistent with that previously reported in other tumor types.OpdivoCombinationIpilimumabThe proportion of patients in the Opdivo group or Opdivo plus chemotherapy group who experienced grade 3 or 4 treatment-related adverse events (TRAEs) was 32% and 47%, respectively, compared with 36% in the chemotherapy group, and the safety profile in the PD-L1-positive patient population was consistent with that in the overall randomized population.

“The median overall survival for patients with advanced esophageal squamous cell carcinoma receiving chemotherapy alone is approximately 10 months. Therefore, innovative treatment options superior to the current standard of care are urgently needed,” said Dr. Ian Chau, Consultant Medical Oncologist at The Royal Marsden NHS Foundation Trust. “The data presented at ASCO demonstrates that, compared with chemotherapy, the twoNivolumab...-based treatment options can significantly improve patient survival and are expected to provide a potential new treatment option for this patient population.。”

In PD-L1-positive patients,OpdivoThe median duration of response (DoR) assessed by BICR in the combination chemotherapy group was 8.4 months,OpdivoCombinationIpilimumabgroup was 11.8 months, and the chemotherapy-alone group was 5.7 months. In the overall randomized population,OpdivoCombination Chemotherapy Group、OpdivoCombinationIpilimumabThe DoRs for the group, the group, and the chemotherapy-alone group were 8.2 months, 11.1 months, and 7.1 months, respectively.

OpdivoThe combination chemotherapy group also demonstrated a clinically meaningful benefit in objective response rate (ORR). In the PD-L1-positive patient population,OpdivoThe BICR-assessed ORR in the combination chemotherapy arm was 53%,OpdivoCombinationIpilimumabgroup was 35%, and the chemotherapy-alone group was 20%. In the overall randomized population,Opdivocombination chemotherapy group、OpdivoCombination`Ipilimumab`group, and the chemotherapy-only group had ORRs of 47%, 28%, and 27%, respectively.

CheckMate -648 isWorld's FirstA Phase III Clinical Study Evaluating Immunotherapy Combined with Chemotherapy and Dual Immunotherapy in Patients with Advanced Esophageal Squamous Cell Carcinoma.

“The newly released data provide us with additional evidence-based support, further demonstrating thatOpdivo"Clinical benefits can be achieved in the treatment of upper gastrointestinal malignancies from advanced to early-stage disease," said Dr. Ian M. Waxman, Head of Gastrointestinal Oncology R&D at Bristol-Myers Squibb Company. "Currently,OpdivoIt has been proven to demonstrate superior therapeutic efficacy as a first-line treatment for upper gastrointestinal malignancies across various histological types and tumor sites.”