Core Insights - Novartis will present over 70 abstracts at the upcoming ASH and SABCS meetings, highlighting advancements in hematology and oncology, including 11 oral presentations and a late-breaker abstract for the Phase III VAYHIT2 trial of ianalumab in immune thrombocytopenia (ITP) [1][2][3] Hematology Highlights - The pivotal Phase III trial results for ianalumab in ITP patients previously treated with corticosteroids will be presented as a late-breaker [3] - Scemblix (asciminib) shows continued improvement in patient-reported outcomes compared to investigator-selected tyrosine kinase inhibitors in newly diagnosed chronic myeloid leukemia (CML) [2][3] - The 96-week data from the Phase III MANIFEST-2 study of pelabresib plus ruxolitinib in myelofibrosis represents the longest follow-up in a randomized combination trial [3] Oncology Highlights - Kisqali (ribociclib) data from the MONALEESA studies indicate long-term benefits for early and metastatic breast cancer patients [3] - The pooled analysis of patients treated with first-line ribociclib plus endocrine therapy shows long-term progression-free survival [5] - Five-year analysis of distant disease-free survival from the NATALEE trial of ribociclib plus a nonsteroidal aromatase inhibitor in HR+/HER2− early breast cancer patients will be presented [5] Product Information - Novartis has a strong legacy in hematology, having delivered over 10 medicines for more than 15 blood cancers and serious blood disorders over the past two decades [7][8] - The company has been at the forefront of scientific advancements in breast cancer for over 30 years, leading in the discovery of new therapies and combinations [9]

Core Insights - Novartis announced positive results from the five-year analysis of the Phase III NATALEE trial for Kisqali (ribociclib), showing a sustained benefit in reducing the risk of recurrence in high-risk early breast cancer patients [1][2][4] Efficacy Results - The trial demonstrated a 28.4% reduction in the risk of recurrence (HR=0.716; 95% CI 0.618-0.829; nominal p-value <0.0001) for patients treated with Kisqali plus endocrine therapy (ET) compared to ET alone [1] - Five-year invasive disease-free survival (iDFS) rates were 85.5% for the Kisqali plus ET group versus 81.0% for the ET alone group, indicating a 4.5% improvement [2] - A 29.1% risk reduction in distant disease-free survival was also observed [6] Long-term Benefits - The benefits of Kisqali persist beyond the three-year treatment period, providing patients with a greater chance of remaining breast cancer-free [3][4] - Overall survival (OS) showed a trend towards improvement, with a hazard ratio of 0.800, indicating a 20% reduction in the risk of death compared to ET alone [4] Subgroup Analysis - iDFS results across pre-specified subgroups showed consistent benefits: - Stage II: HR 0.660 (3.7% absolute risk reduction) - Stage III: HR 0.730 (5.6% absolute risk reduction) - Node-negative: HR 0.606 (5.7% absolute risk reduction) - Node-positive: HR 0.737 (4.4% absolute risk reduction) [5] Safety Profile - Long-term safety data indicated no new safety signals, with secondary primary malignancies reported at 2.7% for Kisqali plus ET and 3.0% for ET alone [7] Regulatory Status - Kisqali is approved in over 100 countries, including the U.S. and EU, for various indications in HR+/HER2- early and advanced breast cancer [10][11] Clinical Guidelines - Kisqali is recommended as a Category 1 preferred treatment in the NCCN Guidelines for both node-positive and high-risk node-negative early breast cancer [11][12]

Core Insights - Novartis will present new data from 34 abstracts related to its oncology portfolio at the ESMO Congress 2025 in Berlin from October 17-21, 2025 [1] - The company aims to set new standards of care for prevalent cancers, particularly breast and prostate cancer, through innovative therapies like radioligand therapy [2] Oncology Data Highlights - Key data from the PSMAddition trial will be showcased, highlighting the efficacy and safety of Pluvicto combined with standard care versus standard care alone in patients with PSMA-positive metastatic hormone-sensitive prostate cancer [4] - The NATALEE trial will provide five-year outcomes for Kisqali in early breast cancer, offering insights into recurrence risk reduction [4] - New data for Pluvicto and Kisqali strengthens their profiles, indicating potential for new standards of care in earlier disease settings [4] Presentation Details - Pluvicto's Phase 3 trial results will be presented at the Presidential Symposium on October 19, 2025 [3] - Additional presentations for Pluvicto and Kisqali will occur on October 18 and 20, 2025, covering various aspects of their efficacy and safety [3][5] Novartis Oncology Strategy - Novartis focuses on improving the lives of cancer patients and their caregivers by developing innovative and differentiated medicines [6] - The company collaborates with patient advocacy groups and supports education and early cancer screening initiatives [7] - Novartis has approximately 35 research and development projects in oncology, emphasizing technology and patient-centered research [7]

Core Insights - Olema Pharmaceuticals (OLMA) shares have increased by 46.5% in September following a collaboration agreement with Pfizer (PFE) for its lead product candidate, palazestrant [1][6] - The collaboration involves a phase Ib/II study to evaluate the safety and potential combinability of palazestrant with Pfizer's atirmociclib in patients with ER+/HER2- metastatic breast cancer (MBC) [2][6] - Year-to-date, OLMA stock has risen by 37.2%, outperforming the industry growth of 4% [3] Collaboration Details - The phase Ib/II study is expected to enroll approximately 35 patients, with initiation anticipated by the end of 2025 [3] - Pfizer will supply atirmociclib for the study, while Olema will lead the study and retain exclusive global commercial rights to palazestrant [4][6] - This marks Olema's second partnership with Pfizer, the first being established in 2020 [7] Pipeline Development - Olema is also conducting a pivotal phase III OPERA-01 study for palazestrant as a monotherapy in second/third-line ER+/HER2- MBC, with top-line data expected in the second half of 2026 [8] - In partnership with Novartis (NVS), Olema is evaluating palazestrant in combination with Kisqali (ribociclib) in an ongoing phase Ib/II study, with a pivotal phase III OPERA-02 study planned [9][10] - Olema is exploring palazestrant in combination with a PI3Ka inhibitor and an mTOR inhibitor in separate phase I/II studies [11] Additional Investigational Candidates - Olema has a second investigational candidate, OP-3136, currently in a phase I study for advanced solid tumors, with initial results anticipated in 2026 [12][13] - The global market opportunity for OP-3136 in second/third-line ER+/HER2- MBC is estimated at around $5 billion [13]