Bristol-Myers Squibb Soars 10.49% as Opdivo Gains Ground in China Market

On November 11, Bristol-Myers Squibb (BMY) experienced a notable surge, with its stock price rising 10.49% during the trading session. This upswing in value brought the share price to its highest point since September 2023, marking a significant milestone for the company's market performance.

Bristol-Myers Squibb recently announced that its immunotherapy drug, Opdivo (nivolumab injection), has received approval from the China National Medical Products Administration. This approval allows Opdivo, in combination with cisplatin and gemcitabine, to be used as a first-line treatment for adults with unresectable or metastatic urothelial carcinoma. With this new regulatory nod, Opdivo, combined with chemotherapy, becomes the first and currently the only approved immunotherapy in China for the first-line treatment of advanced urothelial carcinoma. This development positions Opdivo as a cornerstone therapy for the entire course of urothelial cancer treatment in the country.

Urothelial carcinoma is one of the most common malignant tumors of the urinary system and its incidence has been rising in China. For patients with metastatic or inoperable disease at diagnosis, first-line therapy offers the best chance for efficacy. However, progress in this area has long been slow, with cisplatin-based chemotherapy from the 1980s remaining the standard-bearer, despite its limited benefits and short patient survival times, leaving a marked unmet clinical need.

The approval is supported by results from the Phase 3 CheckMate-901 study, which demonstrated superior efficacy of the immunotherapy combination compared to standard cisplatin chemotherapy. The trial showed meaningful improvements in both overall survival (OS) and progression-free survival (PFS) for patients.

Main outcomes from CheckMate-901 showed that, after a median follow-up of approximately 33 months, patients receiving Opdivo combined with cisplatin-based chemotherapy followed by Opdivo monotherapy reported a median OS of 21.7 months, compared to 18.9 months for the chemotherapy group alone. This reflects a significant 22% reduction in the risk of death. The median PFS was also improved at 7.9 months, compared to 7.6 months with chemotherapy, with a 28% reduced risk of disease progression or death.

In terms of response, the combination showed clinically meaningful improvements with an objective response rate (ORR) of 57.6%, compared to 43.1% for chemotherapy. Complete response (CR) was achieved in 21.7% of patients, nearly double that of the chemotherapy group (11.8%), with a median duration of response of 37.1 months, nearly three times that of chemotherapy (13.2 months). The safety profile of Opdivo combined with chemotherapy was consistent with prior studies, showing good tolerability over a treatment duration of up to two years without new safety signals.

Additionally, in a post-hoc analysis, the combination showed encouraging results for patients with lymph node-only metastasis, not involving other organs. These patients had a median OS approaching four years (46.3 months), with a 42% reduction in the risk of death and a median PFS of 30.5 months, reflecting a 62% reduction in disease progression or death. Over 80% of patients experienced significant tumor reduction, with more than 60% achieving complete tumor remission.

Opdivo was initially approved in July 2014 as the world's first PD-1 inhibitor. It is now approved in more than 65 countries and regions for 12 cancer types, including lung cancer, head and neck cancer, gastric cancer, esophageal cancer, liver cancer, kidney cancer, colorectal cancer, urothelial carcinoma, melanoma, Hodgkin's lymphoma, pleural tumors, and cancers of unknown primary site. In China, Opdivo-based immunotherapy has secured approval for 11 indications.