Hu5F9, an immune checkpoint inhibitor blocking CD47, has showed promise in working together with rituximab to eliminate non-Hodgkin lymphoma cells. A recent study looked to evaluate the drug in combination with rituximab in a clinical setting.
Hu5F9, an immune checkpoint inhibitor blocking CD47, has showed promise in working together with rituximab to eliminate non-Hodgkin lymphoma cells. A recent study looked to evaluate the combination therapy in a clinical setting.
Researchers conducted a phase 1B study that enrolled 22 patients with relapsed or refractory Hodgkin lymphoma. Hu5F9 was administered intravenously at a priming dose of 1 mg per kg of body weight, with a weekly maintenance dose of 10 mg to 30 mg per kg together with rituximab in order to allow for the evaluation of safety and efficacy in suggesting a phase 2 dose.
Of the 22 patients enrolled, 15 had diffuse large B-cell lymphoma (DLBCL) and 7 had follicular lymphoma. Patients had received a median of 4 (range, 2-10) prior therapies, and 95% of the patients had disease that was refractory to rituximab. The most common adverse events seen in the trial were anemia and infusion-related reactions.
In total, 50% of patients demonstrated an objective response to the therapy, with 36% experiencing a complete response. The rates of objective response and complete response were 40% and 33%, respectively, among patients with DLBCL and 71% and 43%, respectively, among patients with follicular lymphoma. Additionally, at a median follow-up of 6.2 months among patients with DLBCL and 8.1 months in patients with follicular lymphoma, researchers noted that 91% of the responses were ongoing.
Overall, the study authors reported that “The macrophage checkpoint inhibitor [Hu5F9] combined with rituximab showed promising activity in patients with aggressive and indolent lymphoma.” Furthermore, the authors found that there were no clinically significant safety events demonstrated in the trial.
Reference
Advani R, Flinn I, Popplewell L, et al. CD47 blockade by Hu5f9-G4 and rituximab in non-Hodgkin’s lymphoma. N Engl J Med. 2018;379(18):1711-1721. doi: 10.1056/NEJMoa1807315.
Julie Reed: Why 2024 Is Important for Biosimilars
April 17th 2024Julie Reed, executive director of the Biosimilars Forum, showcases how the biosimilar industry is expected to develop throughout 2024, including major policy changes and hope for continued improvement in market share for adalimumab biosimilars.
Alvotech’s Stelara Biosimilar, Selarsdi, Receives FDA Approval
April 16th 2024Alvotech’s Selarsdi (ustekinumab-aekn), a biosimilar referencing Stelara (ustekinumab), gained FDA approval, making it the second ustekinumab biosimilar and second for the company to be given the green light for the American market.
Decoding the Patent Puzzle: Navigating the Legal Landscape of Biosimilars
March 17th 2024On this episode of Not So Different, Ha Kung Wong, JD, an intellectual patent attorney and partner at Venable LLP, details the confusing landscape that is the US patent system and how it can be improved to help companies overcome barriers to biosimilar competition.
BioRationality: Removing the Misconceptions Surrounding Interchangeability
April 15th 2024Sarfaraz K. Niazi, PhD, outlines the current state of interchangeable biosimilars in the US and policy changes needed to clear up misconceptions surrounding the meaning behind interchangeability designations.
Sintilimab, Bevacizumab Biosimilar, HAIC Improves Survival in Patients With Unresectable HCC
April 14th 2024Positive results of sintilimab, IBI305, and hepatic arterial infusion chemotherapy (HAIC) treatment showed shrinking tumors and previously converting inoperable hepatocellular carcinoma (HCC) to resectable HCC with manageable adverse effects.