NEW YORK CITY (dpa-AFX) - Bristol-Myers Squibb Co. (BMY) announced positive results from a cohort of patients in its ongoing Phase 1b trial (CheckMate -039) which evaluated PD-1 immune checkpoint inhibitor, Opdivo (nivolumab), in patients with relapsed or refractory hematological malignancies (n=23).
Results showed high levels of response in patients with relapsed or refractory classical Hodgkin Lymphoma (HL), with an overall response rate of 87% (n=20) and stable disease in 13% (n=3).
In patients with HL, initial treatment typically consists of chemotherapy and/or radiation therapy, followed by an autologous stem cell transplant (ASCT) if the disease recurs. For those who relapse within one year after receiving a standard of care like ASCT, the median survival is only 1.3 years after progression.
CheckMate -039 results support the first Breakthrough Therapy Designation for Opdivo, granted in May 2014 by the U.S. Food and Drug Administration (FDA) for the treatment of patients with HL after failure of autologous stem cell transplant and brentuximab.
Bristol-Myers Squibb has proposed the name Opdivo (pronounced op-dee-voh), which, if approved by health authorities, will serve as the trademark for nivolumab.
CheckMate -039 is an ongoing Phase 1 dose escalation study of patients with relapsed and refractory hematological malignancies, which includes a cohort evaluating Opdivo in patients with HL after failure of autologous stem cell transplant and brentuximab. The cohort includes 23 patients who were treated with Opdivo 3 mg/kg at week one, week four and every two weeks until disease progression or complete response or for a maximum of two years.
The primary endpoints included evaluating the safety and tolerability of Opdivo. Secondary endpoints included determining antitumor activity, characterizing Opdivo pharmacokinetics and immunogenicity, and assessing PD-L1 and PD-L2 expression as a predictive biomarker.
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