Venetoclax

Pictured: AbbVie office in San Francisco, California/iStock, Michael Vi AbbVie on Friday beat Wall Street expectations in its first quarter of 2024, thanks in part to robust sales of its immunology drugs Rinvoq and Skyrizi, the company announced. The company said it is raising its guidance for the full-year 2024 from $10.97 to $11.17 per share to $11.13 to $11.33 per share. AbbVie also reported net revenue of over $12.3 billion, a 0.7% increase from the first quarter of 2023. Skyrizi’s worldwide revenue for Q1 was more than $2 billion, a 47% increase from the first quarter of last year and beating estimates of $1.94 billion. Rinvoq brought in $1.09 billion in global sales, a 59% increase from Q1 2023 and narrowly higher than expectations of $1.06 billion. AbbVie’s immunology sector overall pulled in a total of $5.3 billion globally in Q1, representing a 3.9% decrease from last year. The company said the drop was due to biosimilar competition for its arthritis drug Humira, which posted global sales of $2.27 billion in the quarter, a 35% decrease from the same period last year and mostly in line with estimates of $2.28 billion. Earlier this year, Humira maintained its dominance and only ceding 2% of its market share to competing biosimilars. However, the competition spiked this month as new prescriptions for Humira biosimilars increased by 36% after CVS Caremark removed AbbVie’s drug from its major formulations in favor of the biosimilars. Nonetheless, William Blair analysts in a Friday note wrote that the company “has managed the erosion well” for Humira and while “some uncertainty remains” they contend “investors now have enough visibility to get comfortable with the strong growth outlook for AbbVie over the near and long term.” AbbVie’s oncology drug Imbruvica, one of the first drugs named to the Medicare drug price negotiations last year, secured $838 million in Q1, a 4.5% drop from the same period last year but beating estimates of $744 million. Venclexta saw a 14% rise in global sales, pulling in $614 million, while Elahere, which secured full approval in March 2024, netted $64 million in the most recent quarter. Overall, the company’s oncology business reported $1.5 billion in global sales, a 9% increase from Q1 2023. “We continue to demonstrate outstanding operational execution and delivered another quarter of strong results,” AbbVie CEO Richard Gonzalez said in a statement. Tyler Patchen is a staff writer at BioSpace. You can reach him at tyler.patchen@biospace.com. Follow him on LinkedIn.

Multiple presentations to showcase the efficacy and safety of BRUKINSA® across a range of B-cell malignancies Company to present three-year data from RATIONALE-306 study of TEVIMBRA® in advanced or metastatic esophageal squamous cell carcinoma (ESCC) BASEL, Switzerland & BEIJING & CAMBRIDGE, Mass.--(BUSINESS WIRE)-- BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), a global oncology company, today announced it will share research outcomes from its broad hematology and solid tumor portfolio at the American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, May 31 - June 4, 2024. “Our presentations at this year’s ASCO highlight the strength of our growing oncology portfolio and our commitment to developing treatments that address the unmet needs of patients with B-cell malignancies and solid tumors,” Mehrdad Mobasher, M.D., M.P.H., Chief Medical Officer, Hematology at BeiGene. “The exciting data we will share during ASCO showcase BRUKINSA’s uniquely differentiated clinical pro add to the growing body of evidence supporting its role across the blood cancer treatment paradigm.” BeiGene will share new data for BRUKINSA (zanubrutinib), which add to the robust efficacy and safety evidence differentiating it within the BTK class. Key highlights include: A network meta-analysis comparing the efficacy of BRUKINSA vs acalabrutinib in patients with relapsed/refractory chronic lymphocytic leukemia (CLL); and A post-hoc analysis from the Phase 3 ALPINE study of BRUKINSA vs ibrutinib evaluating the risk of developing hypertension based on the initiation and adjustment of antihypertensive medications. Reflecting BeiGene’s growing solid tumor development program, TEVIMBRA (tislelizumab-jsgr) will be the subject of multiple presentations – as a monotherapy, in combination with chemotherapy agents, and as part of immunotherapy regimens across a range of tumor types. Key highlights include: New data from the Phase 3 RATIONALE-306 study evaluating TEVIMBRA plus chemotherapy in patients with advanced or metastatic esophageal squamous cell carcinoma (ESCC); and Initial data from a first-in-human study evaluating HPK1 inhibitor BGB-15025 alone and in combination with TEVIMBRA. “Our data at ASCO are a testament to the potential versatility of TEVIMBRA across a range of tumor types, and we are excited by the momentum of this critical pillar of our solid tumor development program,” said Mark Lanasa, M.D., Ph.D., Chief Medical Officer, Solid Tumors at BeiGene. “During the meeting, we look forward to sharing a new analysis from our RATIONALE-306 study, which will provide insights into the three-year efficacy and safety of TEVIMBRA as a first-line treatment for ESCC.” BeiGene Presentations During ASCO 2024 Abstract Title Abstract # Presentation Details Lead Author Hematology Comparative efficacy of Bruton tyrosine kinase inhibitors in the treatment of relapsed/refractory chronic lymphocytic leukemia: a network meta-analysis (NMA) 7048 Session Type and Title: Poster Session – Hematologic Malignancies—Lymphoma and Chronic Lymphocytic Leukemia Session Date and Time: June 3 at 9:00 AM-12:00 PM CDT M. Shadman Real-world treatment patterns and outcomes of zanubrutinib in chronic lymphocytic leukemia and small lymphocytic lymphoma (CLL/SLL) 11158 Session Type and Title: Poster Session – Quality Care/Health Services Research Session Date and Time: June 3 at 9:00 AM-12:00 PM CDT M. Krackeler Risk of hypertension in patients with CLL/SLL who participated in ALPINE: a post hoc analysis N/A Online D. Ramirez Risk of new-onset hypertension in newly diagnosed chronic lymphocytic leukemia (CLL) patients (pts) treated with Bruton tyrosine kinase inhibitors (BTKi): A real-world data study using the Symphony Health Solution database N/A Online T. Kou Real-world treatment switching and sequencing to next line of therapy of zanubrutinib, acalabrutinib, and ibrutinib in CLL/SLL N/A Online J. Pinilla-Ibarz Real-world adherence and healthcare resource utilization of Bruton tyrosine kinase inhibitors (BTKi) in mantle cell lymphoma N/A Online B. Shah Comparison of zanubrutinib (zanu) and acalabrutinib (acala) in B-cell malignancies: an adverse event (AE)-based analysis N/A Online T. Munir Clinical and financial burden of mental health (MH) conditions in patients (pts) with low-grade non-Hodgkin lymphoma (LG-NHL) 7072 Session Type and Title: Poster Session – Hematologic Malignancies—Lymphoma and Chronic Lymphocytic Leukemia Session Date and Time: June 3 at 9:00 AM-12:00 PM CDT K. Yang Real-world evaluation of treatment pattern, time to next treatment (TTNT), healthcare resource utilization (HCRU), and cost of care in follicular lymphoma (FL) N/A Online S. Gaballa Real-world Bruton tyrosine kinase inhibitor (BTKi) treatment patterns and outcomes among patients with chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL) in US community oncology practices N/A Online J. Hou BGB-11417-203, an ongoing, phase 2 study of sonrotoclax (BGB-11417), a next-generation BCL2 inhibitor, in patients with Waldenström macroglobulinemia TPS7090 Session Type and Title: Poster Session – Hematologic Malignancies—Lymphoma and Chronic Lymphocytic Leukemia Session Date and Time: June 3 at 9:00 AM-12:00 PM CDT H. Lee CELESTIAL-TNCLL: An ongoing, open-label, multiregional, phase 3 study of sonrotoclax (BGB-11417) + zanubrutinib vs venetoclax + obinutuzumab for treatment-naïve (TN) CLL TPS7087 Session Type and Title: Poster Session – Hematologic Malignancies—Lymphoma and Chronic Lymphocytic Leukemia Session Date and Time: June 3 at 9:00 AM-12:00 PM CDT M. Shadman Solid Tumor/IO Global, randomized, phase III study of tislelizumab plus chemotherapy versus placebo plus chemotherapy as first-line treatment for advanced/metastatic esophageal squamous cell carcinoma (RATIONALE-306 update): minimum 3-year survival follow-up 4032 Session Type and Title: Poster Session – Gastrointestinal Cancer—Gastroesophageal, Pancreatic, and Hepatobiliary Session Date and Time: June 1 at 1:30-4:30 PM CDT H. Yoon BGB-A317-212: A multicenter, open-label, phase II study to evaluate the efficacy and safety of tislelizumab in combination with lenvatinib in patients with selected solid tumors 2610 Session Type and Title: Poster Session – Developmental Therapeutics—Immunotherapy Session Date and Time: June 1 at 9:00 AM-12:00 PM CDT L. Yufei Preoperative (neoadjuvant) therapy with tislelizumab for locally advanced colorectal cancer with high microsatellite instability or deficient mismatch repair: an open-label, single-arm, multicenter phase II study 3599 Session Type and Title: Poster Session – Gastrointestinal Cancer—Colorectal and Anal Session Date and Time: June 1 at 1:30-4:30 PM CDT K. Ding Tislelizumab First-Line (1L) Gastric/Gastroesophageal Junction Cancer (G/GEJ) Treatment Efficacy on PRO-Based Symptom Endpoints Adjusting for Informative Missing Data Bias: Results from RATIONALE 305 2605 Session Type and Title: Poster Session – Developmental Therapeutics—Immunotherapy Session Date and Time: June 1 at 9:00 AM-12:00 PM CDT D. Serrano A first‑in‑human phase 1a dose‑escalation study of BGB‑15025 (HPK1 inhibitor) as monotherapy and in combination with tislelizumab (TIS; anti‑PD‑1 antibody) in patients (pts) with advanced solid tumors 2585 Session Type and Title: Poster Session – Developmental Therapeutics—Immunotherapy Session Date and Time: June 1 at 9:00 AM-12:00 PM CDT S. Deva Long-term pooled safety analysis of tislelizumab as monotherapy or in combination with chemotherapy in patients with advanced cancers. N/A Online C. Zhou About BRUKINSA® (zanubrutinib) BRUKINSA is a small molecule inhibitor of Bruton’s tyrosine kinase (BTK) designed to deliver complete and sustained inhibition of the BTK protein by optimizing bioavailability, half-life, and selectivity. With differentiated pharmacokinetics compared with other approved BTK inhibitors, BRUKINSA has been demonstrated to inhibit the proliferation of malignant B cells within a number of disease-relevant tissues. Please see full U.S. Prescribing Information for BRUKINSA® (zanubrutinib), including U.S. Patient Information or visit . About TEVIMBRA® (tislelizumab-jsgr) Tislelizumab is a uniquely designed humanized immunoglobulin G4 (IgG4) anti-programmed cell death protein 1 (PD-1) monoclonal antibody with high affinity and binding specificity against PD-1. It is designed to minimize binding to Fc-gamma (Fcγ) receptors on macrophages, helping to aid the body’s immune cells to detect and fight tumors. Please see full U.S. Prescribing Information for TEVIMBRA® (tislelizumab-jsgr), including Medication Guide. About Sonrotoclax (BGB11417) Sonrotoclax is an investigational small molecule B-cell lymphoma 2 (BCL2) inhibitor. It belongs to a class of BCL2 homology 3 (BH3) mimetics, and preclinical and IND-enabling studies have demonstrated potent activity and high selectivity of sonrotoclax against the antiapoptotic protein BCL2. Sonrotoclax is more potent and selective for BCL2 relative to BCLxL than venetoclax and shows the potential to overcome common BCL2 resistance mutations. About BeiGene BeiGene is a global oncology company that is discovering and developing innovative treatments that are more affordable and accessible to cancer patients worldwide. With a broad portfolio, we are expediting development of our diverse pipeline of novel therapeutics through our internal capabilities and collaborations. We are committed to radically improving access to medicines for far more patients who need them. Our growing global team of more than 10,000 colleagues spans five continents, with administrative offices in Basel, Beijing, and Cambridge, U.S. To learn more about BeiGene, please visit and follow us on LinkedIn, X (formerly known as Twitter), and Facebook. Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and other federal securities laws, including statements regarding the strength and future growth of BeiGene’s oncology portfolio; BeiGene’s ability to develop treatments that address the unmet needs of patients with B-cell malignancies and solid tumors; the versatility of tislelizumab across tumor types; and BeiGene’s plans, commitments, aspirations, and goals under the heading “About BeiGene.” Actual results may differ materially from those indicated in the forward-looking statements as a result of various important factors, including BeiGene’s ability to demonstrate the efficacy and safety of its drug candidates; the clinical results for its drug candidates, which may not support further development or marketing approval; actions of regulatory agencies, which may affect the initiation, timing, and progress of clinical trials and marketing approval; BeiGene’s ability to achieve commercial success for its marketed medicines and drug candidates, if approved; BeiGene’s ability to obtain and maintain protection of intellectual property for its medicines and technology; BeiGene’s reliance on third parties to conduct drug development, manufacturing, commercialization, and other services; BeiGene’s limited experience in obtaining regulatory approvals and commercializing pharmaceutical products; BeiGene’s ability to obtain additional funding for operations and to complete the development of its drug candidates and achieve and maintain profitability; and those risks more fully discussed in the section entitled “Risk Factors” in BeiGene’s most recent annual report on Form 10-K, as well as discussions of potential risks, uncertainties, and other important factors in BeiGene’s subsequent filings with the U.S. Securities and Exchange Commission. All information in this press release is as of the date of this press release, and BeiGene undertakes no duty to update such information unless required by law. View source version on businesswire.com: Contacts Investor Contact: Liza Heapes +1 857-302-5663 ir@beigene.com Source: BeiGene, Ltd. View this news release online at: