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Phase 3 Maintenance Results Show Patients with Crohn’s Disease Receiving Risankizumab (SKYRIZI®) Achieved Endoscopic Response and Clinical Remission at One Year

The Pharma Data

After one year, 47 percent of patients receiving risankizumab 360 mg achieved endoscopic response compared with 22 percent of patients in the induction-only control group (p<0.001). analysis plan), with 52 percent on risankizumab 360 mg achieving clinical remission versus 41 percent in the induction-only control group (p<0.01).

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Second Phase 3 Induction Study Confirms Upadacitinib (RINVOQ™) Improved Clinical, Endoscopic and Histologic Outcomes in Ulcerative Colitis Patients

The Pharma Data

AbbVie (NYSE: ABBV) today announced that upadacitinib (45 mg, once daily) met the primary endpoint of clinical remission (per Adapted Mayo Score) and all ranked secondary endpoints in the Phase 3 induction study, U-ACCOMPLISH. All primary and ranked secondary endpoints achieved p-values of <0.001 versus placebo.

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AbbVie Presents New Late-Breaking Data Analyses Showing Risankizumab (SKYRIZI®) Achieves Clinical Remission and Endoscopic Response at Week 12 in Patients with Moderate to Severe Crohn’s Disease

The Pharma Data

All differences between the overall risankizumab dose groups and placebo are statistically significant, with p-values <0.001. Risankizumab (SKYRIZI) is part of a collaboration between Boehringer Ingelheim and AbbVie, with AbbVie leading development and commercialization globally. About AbbVie in Gastroenterology.

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New Data Shows AbbVie’s VENCLYXTO®/VENCLEXTA® Fixed Duration Combination Demonstrates Sustained Progression-Free Survival in Chronic Lymphocytic Leukemia Patients after Three Years off Treatment

The Pharma Data

vice president and head, global oncology development, AbbVie. VENCLYXTO/VENCLEXTA is being developed by AbbVie and Roche. It is jointly commercialized by AbbVie and Genentech, a member of the Roche Group, in the U.S. and by AbbVie outside of the U.S. 1.35]; P=0.49). VENCLYXTO is being developed by AbbVie and Roche.

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CAPTIVATE Study Shows an IMBRUVICA® (ibrutinib) Plus VENCLEXTA®/VENCLYXTO® (venetoclax) Chemotherapy-Free Combination Has Potential to Provide Remission After Fixed-Duration Treatment for Chronic Lymphocytic Leukemia (CLL)

The Pharma Data

This rate was higher than the 37% minimum meaningful rate study assumption (P<0.0001). “Combining our novel therapies to deliver a new potential treatment is an example of AbbVie’s innovative approach to identify options for difficult-to-treat blood cancers, like CLL,” said Mohamed Zaki , M.D., NORTH CHICAGO, Ill.

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IMBRUVICA® (ibrutinib) Plus VENCLEXTA®/VENCLYXTO® (venetoclax) Combination Shows Superior Progression-Free Survival Compared to Chlorambucil Plus Obinutuzumab in First-line Chronic Lymphocytic Leukemia (CLL) Phase 3 GLOW Study

The Pharma Data

The study met its primary endpoint of superior progression-free survival (PFS) as assessed by an independent review committee (IRC) with a HR 0.216 (95% CI, 0.131-0.357; p < 0.0001), demonstrating a reduction in the risk of disease progression or death for I+V of approximately 78% compared to C+O. vs. 11.4%) (p < 0.0001).

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Results from IMBRUVICA® (ibrutinib) RESONATE-2 Study Provide Up to Seven Years of Progression-Free and Overall Survival Data in First-Line Chronic Lymphocytic Leukemia (CLL)

The Pharma Data

June 4, 2021 /PRNewswire/ — AbbVie (NYSE: ABBV), today announced extended long-term data from the Phase 3 RESONATE-2 study ( PCYC-1115/1116 ) evaluating single-agent IMBRUVICA (ibrutinib) versus chlorambucil with up to seven years of follow-up in patients with chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL).