Friday, April 29, 2016
Bristol-Myers Squibb announced today that the Singapore Health Sciences Authority (HSA) has approved the use of the first immuno-oncology agent in Singapore, Opdivo® (nivolumab), to treat adults with locally-advanced or metastatic non-small cell lung cancer (NSCLC) who do not respond to first-line chemotherapy treatment. Opdivo® has also been approved by the HSA to treat advanced melanoma (skin cancer) in adults.
Opdivo® has proven its superior overall survival compared to chemotherapy in locally-advanced or metastatic NSCLC. Both CheckMate -057 and -017 are landmark, comparative studies designed with the goal of demonstrating survival. In these clinical trials, the median overall survival rate (OS) for metastatic non-squamous NSCLC was 51% and squamous NSCLC was 42%.
In non-squamous NSCLC patients, the median OS was 12.2 months in the Opdivo® group and 9.4 months in the chemotherapy group, which translates to a 27% reduction in the risk of death with Opdivo® compared to chemotherapy. Over in the squamous NSCLC population, the median OS was 9.4 months in the Opdivo® arm and 6.0 months in the chemotherapy arm, translating to a 41% reduction in the risk of death with Opdivo® compared to chemotherapy.
Opdivo® belongs to a new class of drugs known as PD-1 inhibitors, which activate the immune system to attack tumours. Opdivo® uses the PD-1 checkpoint protein found on immune cells that are known as T cells. The PD-1 checkpoint protein prevents the T cells from attacking healthy cells in the body. PD-1 protein essentially acts as an ‘off switch’2. As it activates the immune system to find and fight cancer, it is known as an immuno-oncology agent. While other forms of cancer treatment can harm and damage healthy cells while attacking cancer cells, immuno-oncology agents does not attack the healthy cells in your body.
For several decades now, lung cancer has been the most common cancer globally, with an estimated 1.8 million new cases in 2012 (12.9% of total cancer cases)3. On the local front, the Singapore Cancer Registry reported that 5,732 men and women died from lung cancer from 2010 to 2014, making it one of the deadliest cancer in Singapore4. There are two types of lung cancer – NSCLC and small cell lung cancer, with NSCLC being the most common type of lung cancer. NSCLC is further divided into squamous and non-squamous types. In Singapore, NSCLC comprises close to 90% of all lung cancer cases and most are diagnosed at an advanced stage5. Less than 30% of advanced NSCLC patients respond to first-line chemotherapy treatment.
"As oncologists, we often have patients ask us how much time they have left. Transforming cancer into a chronic disease with extended survival and quality of life represents the ultimate goal of treatment," said Dr Lim Hong Liang, Medical Oncologist at Parkway Cancer Centre. With immunooncology innovations like Opdivo®, patients with advanced lung cancer who do not respond to or tolerate chemotherapy, now have hope for longer overall survival. Opdivo® is well-tolerated, suitable for a wide group of patient and they may experience better management of their condition as well as longer duration of response," emphasized Dr Lim.
“Immuno-oncology has been recognized worldwide as one of the most significant advances in cancer treatment,” said Joyce Lee, Country Manager, Singapore of Bristol-Myers Squibb. “With today’s HSA approval, Bristol-Myers Squibb is pleased to know that Opdivo® will be made available for patients in Singapore and around the region who come to Singapore to seek treatment. Opdivo® is a mark of our commitment to further discover, develop and deliver innovative medicines that have the potential to transform the lives of the patients we work for.”
Opdivo® was approved in Singapore by the HSA on 4 April 2016. The drug is administered as an intravenous infusion upon prescription in a hospital or clinic, under the supervision of an experienced healthcare professional. Opdivo® has been approved for use in 50 countries worldwide, including the U.S. and Europe.
Immuno-Oncology at Bristol-Myers Squibb
Surgery, radiation, cytotoxic or targeted therapies have represented the mainstay of cancer treatment over the last several decades, but long-term survival and a positive quality of life have remained elusive for many patients with advanced disease. To address this unmet medical need, Bristol-Myers Squibb is leading research in an innovative field of cancer research and treatment known as Immuno-Oncology, which involves agents whose primary mechanism is to work directly with the body’s immune system to fight cancer. The company is exploring a variety of compounds and immunotherapeutic approaches for patients with different types of cancer, including researching the potential of combining Immuno-Oncology agents that target different pathways in the treatment of cancer. Bristol-Myers Squibb is committed to advancing the science of Immuno- Oncology, with the goal of changing survival expectations and the way patients live with cancer.
About Bristol-Myers Squibb
Bristol-Myers Squibb is a global pharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. For more information about Bristol-Myers Squibb, visit www.bms.com, or follow us on Twitter at http://twitter.com/bmsnews.
Issued on behalf of Bristol-Myers Squibb by WE Communications
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