Opdivo (nivolumab) demonstrates that the high overall response rate of 87% for the treatment of relapse or refractory Hodgkin's lymphoma
Opdivo
Treatment of metastatic melanoma, Non-Small cell Lung cancer, renal cell carcinoma, Hodgkin's disease, head and neck cancer, carcinoma carcinoma, Colorectal cancer
Update: Opdivo (nivolumab) now FDA approved – December 22, 2014
Opdivo (nivolumab) demonstrates that the high overall response rate of 87% for the treatment of relapse or refractory Hodgkin's lymphoma
PRINCETON, N. J., December 6, 2014 — Bristol-Myers Squibb Company (NYSE: BMY) today announced positive results from a cohort of patients as part of the trial Phase 1b (MAT-039) evaluation of PD-1 immune control point of The inhibitor, Opdivo (nivolumab), in patients relapsed or refractory hemic malignant (n = 23). The results showed high levels of response in relapsing or refractory patients classic Hodgkin's lymphoma (LH), with an overall response rate of 87% (n = 20) and a stabilization of the disease in 13% (n = 3). These results were published today in the New England Journal of Medicine (NEJM) and highlighted in the press briefing on Saturday, December 6, at the 56th annual Meeting of the American Society of Hematology (Abstract #289).
In patients with HL, the initial treatment usually consists of chemotherapy and/or radiotherapy, followed by autografting of stem cells (ASCT) if the disease reoccurs. For those who relapse within one year after receiving a standard of care such as the GATS, the median survival is only 1.3 years after the progression.
"Despite the current treatment of the landscape, this patient population is still experiencing relatively short lifespan of the responses that often result from relapse. So there is a critical need to identify new options that can improve results during their care, "said Philippe Armand, Ph.D., Ph. D, medical oncologist, Dana-Farber Cancer Institute and associate professor, Department of Medicine, Harvard Medical School. "These results with Opdivo are very encouraging as they show that the immuno-oncology approach with a checkpoint blockade has the potential to be applied to lymphomas."
Checkmate-039 results confirm the first breakthrough of the designation therapy for Opdivo, granted in May 2014 by the Food and Drug Administration (FDA) for the treatment of patients with HL, after the failure of autologous stem cell transplant and Brentuximab.
"Bristol-Myers Squibb has a longstanding commitment to the treatment of hematologic cancers, and we continue to advance the potential treatment options for this patient population through our leadership in Immuno-oncology," Said Michael Giordano, senior vice-president, development, Oncology, Bristol-Myers Squibb. "These new data from Opdivo represent the next step towards our goal of identifying therapies that can transform the standard of care through a variety of types of cancer."
Monday, December 8, the results of Mat-039 will be highlighted in another oral presentation (abstract No. 291) that could support Opdivo's potential to treat relapse or refractory non-Hodgkin's lymphoma patients. This Phase 1 study of the trial is also studying the combination of Opdivo and Yervoy in malignant hemic. The data from this arm of the study will be published at a later date.
Bristol-Myers Squibb proposed the name Opdivo (pronounced op-dee-Voh), which, if approved by the health authorities, would use it as a trade-mark for the nivolumab.
About Checkmate-039
Checkmate-039 is a Phase 1 study of the increasing-dose study of relapse and refractory hemic malignant patients, which includes a cohort evaluating Opdivo in patients with HL, after the failure of autologous stem cell grafting and Brentuximab. The cohort comprises 23 patients who were treated with Opdivo 3 mg/kg in one week, the week of four and every two weeks until progression of the disease or full response or for a maximum of two years. The main evaluation criteria included the assessment of the safety and tolerability of Opdivo. The secondary criteria included the determination of antitumor activity, the characterization of Opdivo pharmacokinetics and the immunogenicity and evaluation of PD-L1 and PD-L2 expression as a predictive biomarker.
In the trial, 87% (n = 20) reached a global response, with 17% (n = 4) Full response completion and 70% (n = 16) a partial response. The rest of the patients, 13% (n = 3), had a stabilization of the disease. of patients with complete and partial response, 60% (n = 12) had their first response within an eight-week period (range: 3-39 weeks). The study data also showed a progression-free survival rate of 86% to 24 weeks, which means patients lived six months longer without worsening their disease.
Safety results were reported in all patients treated in the study. Overall, adverse drug reactions of all grades were reported in 78% of patients (n = 18), the most common being skin rash (22%) and a decrease in platelet count (17%). Of these, Grade 3 adverse events occurred in 22% of patients (n = 5). There were no effects related to Grade 4 treatment or 5 adverse events.
On Opdivo
Cancer cells can exploit "regulatory" pathways, such as control point pathways, to hide the immune system and shield the tumor from attacking the immune system. Opdivo is experimental in nature, fully male PD-1 immune control point of inhibitor that binds the control point of receptor PD-1 (programed death-1) expressed on activated T cells.
Bristol-Myers Squibb has an extensive global development program for the study of Opdivo in several types of tumours comprising more than 50 trials in monotherapy or in combination with other therapies – of which more than 7 000 patients were recruited in the World. Among these are potentially several registrational non-small cell lung cancer tests (NSCLC), melanoma, renal cell carcinoma (RCC), head and neck cancer, glioblastoma and non-Hodgkin's lymphoma.
In 2012, the FDA granted the designation Fast Track for Opdivo in NSCLC, melanoma and CCR. In April 2014, the company launched a submission to the FDA for Opdivo third-line pre-treatment of squamous cancer NSCLC cells and expects to complete the presentation by the end of the year. The FDA granted Opdivo Breakthrough therapy designation in May 2014 for the treatment of patients with Hodgkin's lymphoma, after the failure of autologous and brentuximab stem cell grafting. On July 4, Ono Pharmaceutical Co. announced that Opdivo received manufacturing and marketing approval in Japan for the treatment of patients with non-resectable melanoma, making Opdivo the first PD-1 immune control point of The inhibitor to receive regulatory approval anywhere in the world. On September 26, Bristol-Myers Squibb announced that the FDA has accepted a priority review of the previously processed Biologics Licence Application Directorate, advanced melanoma, and Prescription Drug User Fee Act Purpose of the decision date is March 30, 2015. The FDA has also granted Opdivo breakthrough of status therapy for this indication. In the European Union, the European Medicines Agency (EMA) has confirmed, for consideration of the marketing authorisation of the Application for Opdivo in advanced melanoma. The application was also granted for accelerated evaluation by the CHMP of the EMA. EMA also validated for the revision of the Nivolumab agreement in the NSCLC.
On Hodgkin's lymphoma
Hodgkin's Lymphoma (LH), also known as Hodgkin's disease is a cancer of the lymphatic system, which originates in white blood cells. HL is one of the two main types of lymphomas. The five-year survival of HL advance rates is about 65 percent in the United States, the average age of diagnosis is 38 in the United States this year, more than 9 100 new cases are estimated to be diagnosed with more than 1 100 expected deaths.
Immuno-Oncology in Bristol-Myers Squibb
Surgery, radiotherapy, lymphocytes or targeted therapies have been the mainstay of cancer treatment in recent decades, but long-term survival and a good quality of life have remained out of reach for many patients at a Advanced stage of the disease.
To address this unmet medical need, Bristol-Myers Squibb is at the forefront of advances in the areas of immuno-oncology innovation, which involves agents whose main mechanism is to work directly with the system Immune to fight cancer. The company is in the process of exploring a variety of compounds and immunotherapeutic approaches for patients with different types of cancer, including research on the potential of the combination of immuno-oncology agents that target Different and complementary pathways in the treatment of cancer.
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