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Enliven Therapeutics Early Leukemia Drug Results Impress, Stock Soars
Benzinga· 2026-01-08 19:16
Core Viewpoint - Enliven Therapeutics Inc. has reported promising initial data from its Phase 1b ENABLE trial of ELVN-001 for chronic myeloid leukemia, leading to a significant increase in stock price. Group 1: Clinical Data - As of December 22, 2025, 60 heavily pre-treated patients were enrolled in the trial [2] - In the 80 mg QD cohort (n=19), major molecular response (MMR) achievement was 38% and deep molecular response (DMR) was 16%, which is favorable compared to previous Phase 1 trials of approved BCR::ABL1 TKIs [2] - In the randomized 60 mg and 120 mg cohorts (n=41), MMR achievement was 53% and DMR was 35% [3] - Across all Phase 1b cohorts, 100% of evaluable patients who achieved MMR at enrollment maintained or deepened their response [3] Group 2: Safety and Efficacy - Clinical activity was observed at doses from 60 mg to 120 mg QD, with no clear evidence of dose response in efficacy or safety [4] - ELVN-001 demonstrated a favorable safety and tolerability profile across all evaluated doses, consistent with previously reported data, with no maximum tolerated dose and no new safety signals identified [4] Group 3: Future Plans and Market Reaction - The company plans to initiate the ENABLE-2 Phase 3 trial of ELVN-001 in the second half of 2026 [5] - Enliven Therapeutics shares increased by 50.42% to $23.27 at the time of publication [5]
Novartis data underscore pioneering scientific innovation in Hematology and Oncology at ASH and SABCS
Globenewswire· 2025-11-25 06:15
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]
Terns Pharmaceuticals' Leukemia Drug Seen As Potential Disruptor In CML Treatment Landscape, Analyst Upgrades
Benzinga· 2025-11-03 18:05
Core Viewpoint - Terns Pharmaceuticals Inc. is experiencing a significant increase in stock price following positive data from the ongoing CARDINAL trial of TERN-701 for chronic myeloid leukemia (CML), suggesting the potential for TERN-701 to be a transformative therapy in the CML treatment landscape [1][2][3]. Group 1: Trial Data and Efficacy - The CARDINAL trial is currently in the dose-escalation and dose-expansion phases, with 55 patients enrolled as of June 30 [2]. - Among 32 efficacy-evaluable patients, the major molecular response (MMR) achievement rate at 24 weeks is reported at 64%, which is significantly higher than rates in other Phase 1 studies of CML therapies [2][3]. - The overall cumulative MMR rate is 75% (24 out of 32 patients), with 100% (10 out of 10) maintaining MMR [6]. Group 2: Market Reaction and Analyst Sentiment - TERN stock has surged by 88.67%, reaching $15.58 [4]. - William Blair has upgraded Terns to Outperform from Market Perform, highlighting the promising outcomes of the TERN-701 readout [3]. - Analyst Andy Hsieh believes that TERN-701 has the potential to significantly disrupt the current CML treatment market, which is dominated by Novartis AG's Scemblix [3].