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.
Cordavis Report Outlines Strategies for Biosimilar Development, Access in the US Health Care Market
May 8th 2024Cordavis, a CVS Healthspire company, released a report detailing the current hurdles faced in developing and commercializing biosimilars in the US and highlighting efforts by the organization to enhance access and affordability for these products.
Biosimilars Policy Roundup for April 2024—Podcast Edition
May 5th 2024On this episode of Not So Different, The Center for Biosimilars® glances back at all the major biosimilar policy updates from April, including 2 FDA approvals, 1 European approval, and several insights into possible policy changes from the Festival of Biologics USA conference.
Review: Product Attributes Relevant to Injection-Site Pain, Adalimumab Treatment
May 4th 2024A review article summarizes the product attributes of reference and biosimilar adalimumab products, such as formulation with or without citrate, delivery volume, and needle gauge, relevant to patients’ experience of injection-site pain.
Cencora Analysis Shows Differences in Payer Coverage Between G-CSF Biosimilars
May 2nd 2024Data from a Cencora study showed some misalignment in payer coverage of granulocyte colony-stimulating factor (G-CSF) biosimilars, highlighting that while filgrastim biosimilars are often favored over the originator, reference pegfilgrastim still dominates over its biosimilars.