Kisqali (ribociclib)

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Novartis to showcase transformative data in advanced prostate and early breast cancer at ESMO 2025
Globenewswire· 2025-09-26 05:15
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]
OLMA Stock Soars 47% in September So Far on Second PFE Deal
ZACKS· 2025-09-12 15:41
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]