Bristol Myers Squibb's Opdivo Gains Second Indication in China for Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma
Bristol-Myers Squibb
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EO Intelligence, October 8 – Bristol-Myers Squibb announced that its PD-1 monoclonal antibody Opdivo (nivolumab) has received formal approval from China’s National Medical Products Administration for the treatment of patients with disease progression during or after platinum-based therapy and whose tumors are PD-L1 positive (PD-L1 expression in tumor cells ≥1%).Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma(SCCHN) patients. It is reported that this is the approval of Opdivo in ChinaSecond Indication。
On June 15 last year, Opdivo became the first PD-1 monoclonal antibody drug approved in China. Subsequently, Merck & Co.’s PD-1 monoclonal antibody Keytruda (pembrolizumab) also entered the Chinese market. In December of the same year,Junshi Biosciences, Innovent BiologicsIts PD-1 monoclonal antibody received sequential approvals, achieving a “zero breakthrough” for domestically produced PD-1 monoclonal antibody drugs. In May 2019, Hengrui Medicine became the fifth company in China to gain approval for a PD-1 inhibitor, with its product Ailituo.
Unlike traditional treatments such as chemotherapy,Tumor immunotherapy does not directly target cancer cells; instead, it combats tumors by activating the body’s own immune system, thereby offering favorable safety and tolerability profiles.As representative agents of tumor immunotherapy, PD-1/PD-L1 antibody drugs have garnered significant attention in the treatment of advanced malignant tumors in recent years, with numerous successful cases reported. With the approval of five PD-1 monoclonal antibodies in China since last year, the competitive landscape of oncology drugs is quietly undergoing a transformation.
However,In terms of indications, most domestically approved PD-1 monoclonal antibodies remain relatively limited in scope.Among them, Bristol-Myers Squibb'sOpdivoPreviously, the main focus was onLocally Advanced or Metastatic Non-Small Cell Lung Cancer(NSCLC) adult patients; Merck & Co.’sKeytrudais indicated for patients who have failed first-line therapyUnresectable or Metastatic Melanoma; Junshi Biosciences'TuoyiFor the treatment ofMelanoma; Innovent Biologics'Tyvytand Jiangsu Hengrui Medicine Co., Ltd.'sErbituxconsistent with the indications, both used for patients who have received at least second-line systemic chemotherapyRelapsed or Refractory Classical Hodgkin LymphomaPatient Treatment.
The approval of Opdivo’s second indication in China undoubtedly marks a new breakthrough for domestic PD-1 monoclonal antibody drugs, particularlyIn the field of immunotherapy for head and neck squamous cell carcinoma, Opdivo is currently the first and only approved drug in China.
It is understood that squamous cell carcinoma of the head and neck (SCCHN) accounts for more than 90% of all head and neck cancer cases, with approximately 50% of treated patients experiencing recurrence, mostly within two years. The five-year survival rate for patients with recurrent or metastatic stage IV disease is less than 3.6%. Furthermore, organ dysfunction caused by conventional treatments significantly impairs patients’ quality of life.
Bristol-Myers Squibb stated,This approval is based on the positive results from the Phase 3 CheckMate-141 clinical trial, which included patients with recurrent or metastatic head and neck squamous cell carcinoma who had experienced platinum therapy failure, regardless of PD-L1 expression and HPV status.Study results showed that, compared with standard treatment, Opdivo can help patients with recurrent or metastatic head and neck squamous cell carcinoma prolong their expected survival.Risk of death reduced by 32%; atTwo-Year Survival RateOpdivo’s performance reached16.9%, significantly higher than the 6.0% in the control group; furthermore, OpdivoMedian overall survival (OS) reached 7.7 months, while this figure was 5.1 months in the control group.
Professor Ma Jun, Executive Vice President of Sun Yat-sen University Cancer Center, stated that the recent approval of Opdivo will break the decades-long stagnation in new drug development for head and neck squamous cell carcinoma (HNSCC) in China, propelling the treatment of HNSCC in the country into a new era of immunotherapy. However, for Bristol-Myers Squibb,The expansion of Opdivo’s indications has a more direct impact on enhancing the product’s competitiveness and market share.
It is worth noting that,Opdivo has been approved for 15 indications in the United States, for the treatment of 8 different types of cancer., including melanoma, non-small cell lung cancer, renal cancer, Hodgkin’s lymphoma, head and neck cancer, bladder cancer, MSI-H colorectal cancer, and liver cancer. How to gradually transfer this advantage to the Chinese market will be a key step for Bristol-Myers Squibb to seize the current dividends of the transformation from “generic to innovative.”
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Editor: Guo Mingzi
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