- Updated iptacopan data confirm hemolysis control in paroxysmal nocturnal hemoglobinuria (PNH) patients from Phase III APPLY-PNH and APPOINT-PNH studies
- Head-to-head data from Phase III ASCEMBL trial reaffirm Scemblix superiority over Bosulif* in patients with chronic myeloid leukemia (CML) in chronic phase, previously treated with two or more tyrosine kinase inhibitors
- Preliminary global results from large-scale Survey on Unmet Needs in CML disrupt notion that CML is solved and underscore importance of the patient voice in treatment decisions that balance quality of life, efficacy and tolerability goals
Basel, May 11, 2023 — Novartis will present new data across its hematology portfolio at the upcoming European Hematology Association (EHA) 2023 Hybrid Congress, with 40 accepted abstracts, including updated results from pivotal trials for iptacopan and Scemblix®.
“Further scientific advancement is crucial to fulfilling unmet treatment needs for patients living and dealing with daily challenges from devastating cancers and blood disorders,” said Jeff Legos, Executive Vice President, Global Head of Oncology and Hematology Development at Novartis. “Set against the backdrop of our established hematology legacy, we look forward to presenting updated trial results in key areas such as CML and PNH, at EHA.”
Key highlights of data accepted by EHA include:
| Medicine / Therapeutic area | Abstract Title | Abstract Number/ Presentation Details |
| Iptacopan (LNP023) | Oral Iptacopan Monotherapy Increases Paroxysmal Nocturnal Hemoglobinuria (PNH) Red Blood Cell Clone Size via Control of Intra- and Extravascular Hemolysis in Anti-C5-Treated PNH Patients With Anemia | Abstract #S182 Oral Presentation Friday, June 9, 3:15 – 3:30 PM CEST |
| Iptacopan (LNP023) | Substantial Increases in Paroxysmal Nocturnal Hemoglobinuria (PNH) Red Blood Cell Clone Size With Oral Iptacopan Monotherapy Confirms Control of Hemolysis in Complement Inhibitor-Naïve PNH Patients | Abstract #P774 Poster Presentation Friday, June 9, 6:00 – 7:00 PM CEST |
| Scemblix® (asciminib) | Rapid and Deep Responses With Asciminib in Patients (Pts) with Chronic Myeloid Leukemia in Chronic Phase (CML-CP) After ≥2 Prior Tyrosine Kinase Inhibitors (TKIs) in the Phase 3 ASCEMBL Study | Abstract #P665 Poster Presentation Friday, June 9, 6:00 – 7:00 PM CEST |
| Jakavi® (ruxolitinib) | Ruxolitinib in Pediatric Patients With Treatment-Naive or Steroid Refractory Chronic Graft versus Host Disease: Primary Findings From the Phase II REACH 5 Study | Abstract #S245 Oral Presentation Saturday, June 10, 11:30 AM – 12:45 PM CEST |
| Paroxysmal nocturnal hemoglobinuria | Hospitalization in Patients With Paroxysmal Nocturnal Hemoglobinuria: A Retrospective Analysis of Observational Study Data From the United States | Abstract #P796 Poster Presentation Friday, June 9, 6:00 – 7:00 PM CEST |
| Chronic myeloid leukemia | Chronic Myeloid Leukemia Survey on Unmet Needs (CML SUN): Balancing Tolerability and Efficacy Goals of Patients and Physicians Through Shared Treatment Decision-making | Abstract #P668 Poster Presentation Friday, June 9, 6:00 – 7:00 PM CEST |
| Immune thrombocytopenia | Patient (PT) and Physician (MD) Perceptions of the Burden of Immune Thrombocytopenia (ITP) and its Management: Results From the ITP World Impact Survey (I-WISH) 2.0 | Abstract #P1589 Poster Presentation Friday, June 9, 6:00 – 7:00 PM CEST |
Product Information
For full prescribing information, including approved indications and important safety information about marketed products, please visit https://www.novartis.com/about/products.
Disclaimer
This press release contains forward-looking statements within the meaning of the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements can generally be identified by words such as “potential,” “can,” “will,” “plan,” “may,” “could,” “would,” “expect,” “anticipate,” “seek,” “look forward,” “believe,” “committed,” “investigational,” “pipeline,” “launch,” or similar terms, or by express or implied discussions regarding potential marketing approvals, new indications or labeling for the investigational or approved products described in this press release, or regarding potential future revenues from such products. You should not place undue reliance on these statements. Such forward-looking statements are based on our current beliefs and expectations regarding future events, and are subject to significant known and unknown risks and uncertainties. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those set forth in the forward-looking statements. There can be no guarantee that the investigational or approved products described in this press release will be submitted or approved for sale or for any additional indications or labeling in any market, or at any particular time. Nor can there be any guarantee that such products will be commercially successful in the future. In particular, our expectations regarding such products could be affected by, among other things, the uncertainties inherent in research and development, including clinical trial results and additional analysis of existing clinical data; regulatory actions or delays or government regulation generally; global trends toward health care cost containment, including government, payor and general public pricing and reimbursement pressures and requirements for increased pricing transparency; our ability to obtain or maintain proprietary intellectual property protection; the particular prescribing preferences of physicians and patients; general political, economic and business conditions, including the effects of and efforts to mitigate pandemic diseases such as COVID-19; safety, quality, data integrity or manufacturing issues; potential or actual data security and data privacy breaches, or disruptions of our information technology systems, and other risks and factors referred to in Novartis AG’s current Form 20-F on file with the US Securities and Exchange Commission. Novartis is providing the information in this press release as of this date and does not undertake any obligation to update any forward-looking statements contained in this press release as a result of new information, future events or otherwise.
About Novartis
Novartis is reimagining medicine to improve and extend people’s lives. We deliver high-value medicines that alleviate society’s greatest disease burdens through technology leadership in R&D and novel access approaches. In our quest to find new medicines, we consistently rank among the world’s top companies investing in research and development. About 103,000 people of more than 140 nationalities work together to bring Novartis products to nearly 800 million people around the world. Find out more at https://www.novartis.com
Novartis is on Twitter. Sign up to follow @Novartis at https://twitter.com/novartisnews
For Novartis multimedia content, please visit https://www.novartis.com/news/media-library
For questions about the site or required registration, please contact [email protected]
# # #
*BOSULIF® (bosutinib) is a registered trademark of Pfizer.
| Novartis Media Relations E-mail: [email protected] | |||||
| Central | North America | ||||
| Richard Jarvis | +41 79 584 2326 | Julie Masow | +1 862 579 8456 | ||
| Anja von Treskow Anna Schäfers | +41 79 392 9697 +41 79 801 7267 | Michael Meo Mary Carmichael | +1 862 274 5414 +1 862 200 8344 | ||
| Marlena Abdinoor | +1 617 335 9525 | ||||
| Switzerland Satoshi Sugimoto | +41 79 619 2035 | ||||
| Novartis Investor Relations Central investor relations line: +41 61 324 7944 E-mail: [email protected] | |||||
| Central | North America | ||||
| Samir Shah | +41 61 324 7944 | Sloan Simpson | +1 862 345 4440 | ||
| Nicole Zinsli-Somm | +41 61 324 3809 | Parag Mahanti | +1 973 876 4912 | ||
| Isabella Zinck | +41 61 324 7188 | ||||