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AbbVie Reports Positive Phase 3 Results for Lutikizumab
AbbVie announced positive topline results from the Phase 3 INTREPID study evaluating the safety and efficacy of lutikizumab, an investigational dual-variable-domain interleukin 1alpha/1beta antagonist, in adults and adolescents with moderate to severe hidradenitis suppurativa. The study met its primary endpoint and 8 ranked secondary endpoints. In the INTREPID study, patients treated with lutikizumab achieved significantly higher response rates for the primary endpoint of HiSCR75 at Week 16 compared with placebo. HiSCR75 is defined as at least a 75% reduction from baseline in the total abscess and inflammatory nodule count, with no increase in abscess count and no increase in draining fistula count relative to baseline. INTREPID is the first phase 3 study including adults and adolescents with HS to demonstrate statistically significant HiSCR75 response rates at Week 16 as the primary endpoint. Lutikizumab also demonstrated statistically significant improvements across key ranked secondary endpoints, including rapid reductions in HS-related pain and significantly fewer HS flares, compared to placebo. At Week 8, 26.2% of patients treated with lutikizumab achieved NRS3, defined as at least a 3-point reduction from baseline in HS-related skin pain on the Numeric Rating Scale, compared with 15.0% of patients receiving placebo. Improvements in NRS3 were reported as early as Week 1. In addition, at Week 8, 36.0% of patients receiving lutikizumab achieved NRS30, defined as at least a 30% reduction and at least a 2-unit reduction from baseline in HS-related skin pain, compared with 22.8% of patients receiving placebo. Lutikizumab also significantly reduced the occurrence of HS flares during the first 16 weeks compared with placebo. Additional improvements were observed in quality-of-life measures, including changes from baseline in the dermatology life quality index and hidradenitis suppurativa impact assessment. Key potential disease drivers, including IL-17A and IL-17F levels were also reduced over the double-blind 16-week treatment period. These findings reinforce the potential for lutikizumab to address the burden of disease for people living with moderate to severe HS.
AbbVie Completes Agreement with Pan-Canadian Pharmaceutical Alliance
AbbVie is pleased to announce that negotiations with the pan-Canadian Pharmaceutical Alliance have successfully been completed for Elahere, and that a Letter of Intent has been signed by both parties. Following the completion of pCPA negotiations, AbbVie looks forward to continued collaboration with provincial and territorial governments and other key stakeholders to support timely and equitable public reimbursement of Elahere for individuals with FRalpha-positive, platinum-resistant epithelial ovarian, fallopian tube or primary peritoneal cancer.
AbbVie Partners with McLaren Racing for Multi-Year Collaboration
AbbVie and McLaren Racing today announced a multi-year partnership naming AbbVie an Official Pharmaceutical Partner of the McLaren Mastercard Formula 1 Team. At the center of the partnership is AbbVie Race to Innovate, a multi-year, purpose-driven campaign, built on a shared belief that innovation is never finished. Race to Innovate turns McLaren's on-track performance into meaningful impact. AbbVie will donate $10,000 to global charities for every 10 Constructors' Championship points earned by McLaren, reflecting approximately 10% of the global population impacted by autoimmune diseases. Donations will support global patient advocacy organizations that provide education, resources and support for people living with immune-mediated diseases.
AbbVie’s ABBV-466 Shows Significant Efficacy in Crohn's Disease
AbbVie announced that its investigational ABBV-466, a dual-targeting therapy against IL-23 p19 and integrin a4ss7, demonstrated higher rates of endoscopic remission at Week 12 than either monotherapy in patients with Crohn's disease, or CD. The difference in endoscopic remission rates between ABBV-466 and monotherapy groups further increased at Week 24. The findings are from the TARGET-CD study, an ongoing open-label, treat-through, Phase 2a platform study in patients with moderate to severe CD. The findings will be presented as a late-breaking abstract at the ongoing 2026 Annual United European Gastroenterology Week, or UEGW, Congress in Barcelona, October. The TARGET-CD study included 300 patients with moderately to severely active Crohn's disease across the spectrum of disease severity and prior treatment experience. While 25% of patients were biologic-naive, 75% had failed at least one advanced therapy, including 9.3% who had failed prior IL-23 therapy and 12% who had failed a JAK inhibitor; 25% had failed three or more advanced therapies. This patient population reflects the real-world complexity of Crohn's disease, where heterogeneous disease biology can contribute to differences in treatment response across patients. At Week 12, 30.2% of patients treated with ABBV-466 achieved the primary endpoint of endoscopic remission, compared to 21.3% and 18.0% of patients receiving anti-IL-23 p19 monotherapy and anti-alpha4beta7 monotherapy, respectively. An improvement with ABBV-466 was also reported at Week 24, with 40.5% of ABBV-466 treated patients achieving endoscopic remission, compared to 22.4% and 20.0% of patients on risankizumab and trosunilimab monotherapy, respectively. Based on gene expression analyses, ABBV-466 showed colonic epithelial repair and barrier restoration at Week 12, followed by tissue remodeling and metabolic changes at Week 24 that were generally not observed with either monotherapy. Rates of serious adverse events, or SAEs, for ABBV-466 were 10.4% and comparable to risankizumab monotherapy and trosunilimab monotherapy. In the ABBV-466 and trosunilimab monotherapy arms, the most common adverse events were Crohn's disease and nausea. In the risankizumab monotherapy arm, the most common adverse events were Crohn's disease and arthralgia.
AbbVie to Present Tumor Data at 2026 ESMO Congress
AbbVie announced that new and updated data from its broad solid tumor portfolio will be presented at the 2026 European Society for Medical Oncology, ESMO, Congress, taking place October 23-27 in Madrid, Spain. Spanning multiple tumor types, therapeutic modalities and stages of development, the presentations represent AbbVie's most expansive ESMO program to date. Collectively, the findings across Temab-A, ABBV-706, ABBV-969, ABBV-1480, alveltamig, Elahere and Emrelis demonstrate how "AbbVie is leveraging its deep expertise in cancer biology to advance differentiated approaches that address the complexity and heterogeneity of solid tumors and help meet the diverse needs of cancer patients worldwide," the company said.
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