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/Opdivo® approved as China's first and currently only immunotherapy for adjuvant treatment of urothelial cancer
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Opdivo® approved as China's first and currently only immunotherapy for adjuvant treatment of urothelial cancer

Bristol Myers Squibb China
2023/01/19
  • Opdivo is the first and currently the only PD-1 inhibitor that has been proven in global phase III clinical studies to be used in the adjuvant treatment of urothelial cancer to significantly reduce the risk of postoperative recurrence in patients.
  • Compared with the control group, Opdivo's use in the adjuvant treatment of muscle-invasive urothelial carcinoma can double the median disease-free survival (DFS) of patients in the entire population.
  • Including this approval, Opdivo has been approved in China for the early treatment of three tumor types.

BMS

19/01/23

(Shanghai, January 19, 2023) Bristol-Myers Squibb announced that Opdivo ® (nivolumab injection) has been approved by the China National Medical Products Administration as a single agent for the adjuvant treatment of patients with urothelial cancer (UC) who have a high risk of recurrence after radical resection. With this approval, Opdivo becomes the first PD-1 inhibitor approved for adjuvant treatment of urothelial cancer in China. So far, in the treatment of early cancer, Opdivo is currently the only PD-1/PD-L1 inhibitor approved for two adjuvant treatment indications in China.

This approval is based on the CheckMate -274 study, which is a randomized, double-blind, multi-center global Phase III study that included a total of 709 patients, including patients from mainland China. This is the world's first and currently only Phase III clinical study that has proven that immunotherapy as an adjuvant treatment for muscle-invasive urothelial carcinoma (MIUC) can significantly reduce the risk of disease recurrence in patients. The latest study follow-up data shows that the median disease-free survival (DFS) of patients in the Opdivo group was twice that of the placebo control group, reaching 22.0 months (10.9 months in the control group), and the risk of disease recurrence or death was reduced by 30% [1].

In China, the most common subtype of MIUC is muscle-invasive bladder urothelial carcinoma (MIBC) [2] . The exploratory analysis results of the CheckMate -274 study showed that among the MIBC subgroup population, the median DFS of patients in the Opdivo group reached 25.8 months, which was nearly three times that of the control group (9.4 months), reducing the risk of disease recurrence or death by 39% 1 .

"In recent years, the incidence of bladder cancer in China has been on the rise [3]. In 2020, there were 85,700 new cases of bladder cancer in China, and 39,400 deaths [4]. Among them, MIBC has a low pathological stage, high malignancy, and poor prognosis. In the past, more than half of the patients would relapse after radical resection [5]. Currently, there is a lack of adjuvant treatment recommendations supported by high evidence levels for such patients, and some patients are not suitable for existing adjuvant chemotherapy. The treatment needs of patients need to be met." Professor Ye Dingwei, Vice President of Fudan University Cancer Hospital, pointed out, "Nowadays, nivolumab has brought a new treatment option, which means that many Chinese bladder cancer patients are expected to benefit from surgery, and it also marks that adjuvant treatment of urological tumors in China has entered the era of immunotherapy. The CheckMate -274 study confirmed that Opdivo can double the median DFS of patients in the entire population; further exploration shows that the DFS benefits it brings to the MIBC subgroup are also gratifying."

Additionally, Opdivo demonstrated clinically meaningful improvements in secondary and exploratory endpoints. The median extra-urinary tract recurrence-free survival (NUTRFS) of patients who received one-year adjuvant treatment with Opdivo was 26.0 months, nearly twice that of the control group (13.7 months); the median distant metastasis-free survival (DMFS) was nearly one year longer than that of the control group (41.1 months and 29.2 months respectively) 1 . In addition, the safety profile of Opdivo is consistent with that observed in previous clinical studies in other solid tumors.

"For patients with muscle-invasive urothelial cancer who undergo radical cystectomy, distant metastasis after surgery will greatly increase the difficulty of subsequent treatment and is a major risk factor for prognosis. The improvement of DMFS with nivolumab in the CheckMate -274 study further confirms that adjuvant immune therapy can bring more benefits to patients in the earlier stages of urothelial cancer. This approval can be said to be a strong breakthrough for immunotherapy in the early treatment of urothelial cancer in my country." Professor He Zhisong, Director of the Department of Urology at Peking University First Hospital, said, "The exploration of immunotherapy in the field of urothelial cancer has been carried out for a long time. In the case of previous setbacks in the exploration of late-stage first-line and adjuvant treatments, the outstanding results of the CheckMate -274 study have become a landmark breakthrough. In the future, nivolumab is expected to become the standard treatment plan for adjuvant treatment in this field."

Based on the CheckMate -274 study, Opdivo has been included in the "Chinese Society of Clinical Oncology (CSCO) Urothelial Cancer Diagnosis and Treatment Guidelines" [6], the "National Comprehensive Cancer Network (NCCN) Bladder Cancer Clinical Practice Guidelines" [7] and other authoritative domestic and foreign guidelines, becoming the only recommended adjuvant immunotherapy drug for urothelial cancer.

"Thanks to the policy support of the Chinese government to accelerate innovative drugs to benefit patients, Opdivo continues to make breakthrough achievements in the field of early-stage tumor treatment. The approval of the indication for adjuvant treatment of urothelial cancer makes Opdivo the only immuno-oncology drug in my country with three perioperative indications for early-stage tumors. It also marks another important milestone for Bristol-Myers Squibb in implementing the 'China 2030 Strategy.'" Ms. Chen Siyuan, Vice President of Bristol-Myers Squibb, General Manager of China and Asia Regional Marketing, and President of China He said, "During the 40 years since our roots in China, Bristol-Myers Squibb has continued to pay attention to and meet the urgent medical needs of Chinese patients, continuously accelerate the development of indications in the field of immuno-oncology, and expand our innovative leadership in the field of early treatment of more tumor types; at the same time, we actively cooperate with all parties in society to further improve drug accessibility. In the future, we will continue to promote the development of innovative cancer treatments and help build a 'Healthy China'."

Since Opdivo became the first approved tumor immunotherapy drug in China in 2018, Bristol-Myers Squibb has always paid close attention to the accessibility of innovative treatments to Chinese patients. In December 2018, it supported the China Cancer Foundation (CFC) in launching the Opdivo patient assistance project. With the approval of new indications for Opdivo, the China Cancer Foundation announced that the Opdivo Patient Assistance Project will increase the indications for single-drug adjuvant treatment of urothelial cancer with a high risk of recurrence after radical resection, reducing patients' payment pressure and helping more patients gain the opportunity to extend their survival.

The information contained in this material is for reference only. Please follow the advice or guidance of your doctor or other health care professional.

About Odivo

  • Opdivo was approved as the world's first PD-1 inhibitor in July 2014. It has been approved in 66 countries and regions for a total of 12 tumor types*, covering lung cancer, head and neck cancer, gastric cancer, esophageal cancer, liver cancer, kidney cancer, colorectal cancer, urothelial cancer, melanoma, Hodgkin lymphoma, pleural tumors, and tumors of unknown primary site, benefiting more than 590,000 patients worldwide.
  • Opdivo is the first immuno-oncology drug approved for marketing in China. Opdivo-based immunotherapy has been approved for 9 indications in China: 1) Opdivo can be used to treat adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) who are negative for epidermal growth factor receptor (EGFR) gene mutations and negative for anaplastic lymphoma kinase (ALK), and who have previously received platinum-containing chemotherapy or who have disease progression or are intolerable; 2) Opdivo can be used to treat patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) who have disease progression during or after receiving platinum-containing regimens and whose tumors are positive for PD-L1 expression (defined as ≥1% of tumor cells expressing PD-L1); 3) Opdivo can be used to treat patients with advanced or recurrent gastric or gastroesophageal junction adenocarcinoma (GC/GEJ) who have previously received two or more systemic treatment regimens; 4) Opdivo combined with Yiwo can be used for adult patients with unresectable, previously untreated non-epitheloid malignant pleural mesothelioma (MPM); 5) Opdivo combined with fluorouracil-containing and platinum-based drug chemotherapy is suitable for the first-line treatment of patients with advanced or metastatic gastric cancer, gastroesophageal junction cancer or esophageal adenocarcinoma; 6) Opdivo can be used as adjuvant treatment for patients with esophageal cancer or gastroesophageal junction cancer who still have pathological residual disease after neoadjuvant chemoradiotherapy (CRT) and complete surgical resection; 7) Opdivo combined with fluoropyrimidines and platinum-containing chemotherapy is suitable for first-line treatment of patients with advanced or metastatic esophageal squamous cell carcinoma; 8) Opdivo combined with platinum-containing double-drug chemotherapy is suitable for neoadjuvant treatment of resectable (tumor ≥4 cm or lymph node positive) adult patients with non-small cell lung cancer (NSCLC); 9) Opdivo can be used as adjuvant treatment for patients with urothelial carcinoma (UC) who have undergone radical resection and are at high risk of recurrence.
  • Opdivo is the only PD-1 inhibitor directly participated in the development by a Nobel Prize winner in Physiology or Medicine.

*Opdivo-based immune monotherapy and immune combination therapy

[1] Galsky MD, Witjes JA, Gschwend JE, et al. Disease-free survival with longer follow-up from the phase 3 CheckMate 274 trial of adjuvant nivolumab in patients who underwent surgery for high-risk muscle-invasive urothelial carcinoma. Presented at: 22nd Annual Meeting of the Society of Urologic Oncology; December 1-3, 2021; Orlando, FL. Poster 175.

[2] Chinese Guidelines for Diagnosis and Treatment of Urology and Andrology Diseases, 2019: 191.

[3] Zheng RS, Zhang SW, Zeng HM, Wang SM, Sun KX, Chen R, Li L, Wei WQ, He J. Cancer incidence and mortality in China, 2016[J]. JNCC, 2022, 2(1): 1-9. DOI: https://doi.org/10.1016/j.jncc.2022.02.002.

[4] World Health Organization (WHO). GLOBOCAN 2020: Estimated number of incident cases bladder, both sexes, all ages 2020. Accessed March 29, 2022. https://gco.iarc.fr/today/online-analysis-multi-bars.

[5] Witjes JA et al. Muscle-invasive and Metastatic Bladder Cancer Guidelines. European Association of Urology. 2016. https://uroweb.org/guideline/bladder-cancer-muscle-invasive-and-metastatic/. Accessed June 21, 2016.

[6] 2021 Chinese Society of Clinical Oncology (CSCO) Guidelines for the Diagnosis and Treatment of Urothelial Carcinoma, 2021.

[7] NCCN. NCCN Clinical Practice Guidelines in Oncology – Bladder Cancer, 2021.