ABBVIE INC. - ABBV STOCK NEWS

AbbVie reports positive results from the EPCORE NHL-1 phase 2 trial of epcoritamab for relapsed/refractory large B-cell lymphoma (LBCL). The study showed an overall response rate (ORR) of 63% with a complete response (CR) of 39%. Notably, CAR T-naïve patients had a 69% ORR and 42% CR. The safety profile was consistent with prior data, with most adverse effects occurring in the initial treatment phase. These findings were presented at the EHA's Presidential Symposium, highlighting a significant advancement in treatment options for LBCL.

AbbVie announced preliminary data from the Phase 2 REFINE study, showing positive early results for navitoclax combined with ruxolitinib in treating JAK inhibitor naïve myelofibrosis (MF) patients. Data revealed a 63% spleen volume reduction of ≥35% at week 24. Additionally, 41% of evaluable patients reported a ≥50% reduction in symptom scores. No new safety signals were identified, though 97% of patients reported adverse events, with thrombocytopenia being the most common. These findings could support further exploration of navitoclax as a treatment to modify disease progression.

AbbVie announced five-year follow-up results from the Phase 3 CLL14 trial, revealing that over 60% of patients with untreated chronic lymphocytic leukemia (CLL) who received a one-year treatment of venetoclax plus obinutuzumab maintained longer progression-free survival (PFS) compared to those treated with chlorambucil plus obinutuzumab. The median PFS was not reached for the venetoclax group versus 36.4 months for the chlorambucil group (p<0.0001). Moreover, 18.1% of patients treated with venetoclax showed undetectable minimal residual disease after four years, demonstrating the regimen's effectiveness in CLL treatment.

AbbVie announced it will showcase data from its migraine portfolio at the 2022 AHS Annual Scientific Meeting in Denver, June 9-12. The highlights include findings from the Phase 3 PROGRESS trial for atogepant (QULIPTA) in preventing chronic migraine. This research may support a supplemental New Drug Application with the FDA to expand atogepant’s indication. AbbVie will also present data on ubrogepant (UBRELVY) and onabotulinumtoxinA (BOTOX), enhancing its commitment to treating migraine sufferers. A total of 29 abstracts will provide insights into ongoing research in migraine therapies.

AbbVie announced positive outcomes from the Phase 3 SELECT-AXIS 2 trials of upadacitinib (RINVOQ) aimed at treating non-radiographic axial spondyloarthritis (nr-axSpA) and ankylosing spondylitis (AS) in patients with inadequate responses to existing therapies. Both studies met the primary endpoint, achieving the ASAS40 response at week 14—45% for nr-axSpA compared to 23% placebo, and 45% for AS compared to 18% placebo. Safety profiles remained consistent with previous studies, with no new risks identified. Regulatory applications to the FDA and EMA for nr-axSpA are ongoing.

AbbVie announced that The Lancet published results from three pivotal Phase 3 trials of upadacitinib (RINVOQ) for treating moderately to severely active ulcerative colitis. The U-ACHIEVE (induction), U-ACCOMPLISH, and U-ACHIEVE (maintenance) studies demonstrated the efficacy and safety of upadacitinib in patients with inadequate responses to prior therapies. The studies focused on clinical remission and endoscopic improvement over 8 weeks and 52 weeks. While RINVOQ is not yet approved in the EU, it is currently under review by global health authorities.

AbbVie (NYSE: ABBV) announced results from three pivotal Phase 3 clinical trials published in The Lancet, focusing on risankizumab (SKYRIZI) for treating moderately to severely active Crohn's disease. The ADVANCE and MOTIVATE studies evaluated induction therapy efficacy, while the FORTIFY study assessed maintenance therapy. Results showed significant improvements in clinical remission and endoscopic response. However, risankizumab's approval for Crohn's disease is pending, as safety and efficacy are under regulatory review.

Genmab (Nasdaq: GMAB) announced the acceptance of multiple abstracts for presentation at the 2022 ASCO Annual Meeting, showcasing investigational medicines from its pipeline. Key highlights include data from the phase 1b/2 EPCORE™ NHL-2 trial evaluating epcoritamab (DuoBody-CD3xCD20) in B-cell non-Hodgkin lymphoma and an oral presentation of tisotumab vedotin in recurrent or metastatic cervical cancer. The findings reinforce Genmab's commitment to delivering innovative therapies, with partnerships alongside AbbVie (ABBV) and Seagen (SGEN).

AbbVie (NYSE: ABBV) will participate in the Bernstein 38^th Annual Strategic Decisions Conference on June 1, 2022, at 10:00 a.m. Central Time. Richard A. Gonzalez, chairman and CEO, will present. A live audio webcast will be available on AbbVie's Investor Relations website, with an archived version accessible later the same day.

AbbVie focuses on discovering and delivering innovative medicines across various therapeutic areas, including immunology, oncology, and neurology. For more information, visit www.abbvie.com.