ELVN-001 / Enliven Therapeutics - LARVOL DELTA

ENABLE: A Phase 1 Study of ELVN-001, a Novel, Selective ATP-Competitive Inhibitor of BCR::ABL1, in Patients With Previously Treated CP-CML (SOHO 2026) - P1 | " Of 141 patients (median age, 58 years), nine had atypical BCR::ABL1 transcripts and 28 had ABL1 kinase mutations (15 with T315I; 12 with asciminib-resistance mutations); 67% received ≥3 prior TKIs (24% with ≥5 TKIs; 61% prior asciminib; 38% prior ponatinib), with 64% discontinuing the prior TKI due to lack of efficacy (according to ELN guidelines). In this updated analysis of ENABLE, ELVN-001 showed favorable safety and tolerability and robust anti-CML activity in heavily pretreated patients. ABL1: ABL proto-oncogene 1, non-receptor tyrosine kinase, ATP: adenosine triphosphate, BCR::ABL1: breakpoint cluster region–Abelson 1, CML: chronic myeloid leukemia, CP: chronic phase, ELN: European LeukemiaNet, MMR: major molecular response, T315I: threonine-to-isoleucine mutation at position 315."

Clinical • P1 data • Chronic Myeloid Leukemia • Oncology • ABL1 • BCR

ENABLE: A PHASE 1A/1B STUDY OF ELVN-001, A SELECTIVE ACTIVE SITE INHIBITOR OF BCR::ABL1, IN PATIENTS WITH PREVIOUSLY TREATED CML (EHA 2025) - P1 | "The majority of patients (66%) had received ≥3 prior TKIs, including ponatinib (45%) andasciminib (57%). ELVN-001 demonstrated favorable safety and tolerability across a wide range of doses, consistent with its selective kinase profile. Despite the heavily pretreated patient population, encouraging preliminary efficacy was observed, including in patients with asciminib-resistant mutations."

Clinical • P1 data • Chronic Myeloid Leukemia • Hematological Disorders • Neutropenia • Pancreatitis • Thrombocytopenia • ABL1

ENABLE: A Phase 1a/1b Study of ELVN-001, a Selective Active Site Inhibitor of BCR::ABL1, in Patients With Previously Treated Chronic Myeloid Leukemia (SOHO 2025) - P1 | "The majority of patients (66%) had received three or more prior TKIs, including ponatinib (45%) and asciminib (57%). ELVN-001 demonstrated favorable safety and tolerability across a wide range of doses, consistent with its selective kinase profile. Despite the heavily pretreated patient population, encouraging preliminary efficacy was observed."

Clinical • P1 data • Chronic Myeloid Leukemia • Hematological Malignancies • Leukemia • Oncology • ABL1

ENABLE: UPDATED EFFICACY AND SAFETY RESULTS OF ELVN-001, A NOVEL SELECTIVE ATP-COMPETITIVE INHIBITOR OF BCR::ABL1, IN PATIENTS WITH PREVIOUSLY TREATED CP-CML (EHA 2026) - P1 | "The majority of pts (67%) received ≥3 prior unique TKIs, with 24% ≥5; 61% had prior asciminib, 38% prior ponatinib; 64% discontinued their last prior TKI due to lack of efficacy. Summary/Conclusion With longer follow-up and more pts enrolled, ELVN-001 continues to demonstrate robust anti-CML activity despite the heavily pretreated patient population. In addition, ELVN-001 maintains favorable safety and tolerability, consistent with its selective kinase profile."

Clinical • Chronic Myeloid Leukemia • Hematological Disorders • Neutropenia • Thrombocytopenia • ABL1

Enliven Therapeutics…announced that the Company will present data from the ENABLE Phase 1 clinical trial of ELVN-001 in an oral and a poster presentation at the Society of Hematologic Oncology (SOHO) Annual Meeting… (PRNewswire) - "ENABLE is a dose escalation and expansion trial designed to evaluate safety and tolerability and to determine the recommended dose for further clinical evaluation of ELVN-001 in patients with CML with and without T315I mutations that is relapsed, refractory or intolerant to tyrosine kinase inhibitors (TKIs)."

P1 data • Chronic Myeloid Leukemia

The Company also provided an update on recent regulatory interactions with the Food and Drug Administration (FDA) (PRNewswire) - "Key Outcomes from the End-of-Phase 1 Meeting with the FDA: (i) 80 mg QD selected as the recommended dose for Phase 3 ENABLE-2 trial; (ii) ENABLE-2 is expected to enroll patients with CML previously treated with one or more TKIs, and to be randomized to receive either ELVN-001 or physician's choice of an ATP-competitive TKI; (iii) Additional details of the Phase 3 trial design are expected to be finalized following further discussions with the FDA, including at a planned End-of-Phase 2 meeting anticipated in the third quarter of 2026."

FDA event • New P3 trial • Chronic Myeloid Leukemia

Enliven Therapeutics…presented updated positive data from the Phase 1 ENABLE clinical trial evaluating ELVN-001 in patients with previously treated chronic myeloid leukemia (CML) (PRNewswire) - "An oral presentation will be delivered later today at the European Hematology Association (EHA) 2026 Congress....Of the 90 patients enrolled in the Phase 1b, 78 had typical BCR::ABL1 transcripts and had at least one post-baseline transcript; 69 patients were evaluable for major molecular response (MMR) by 24 weeks. Additionally, of the 49 patients enrolled in the 80 mg once daily (QD) Phase 1b cohort, 37 had typical BCR::ABL1 transcripts and had at least one post-baseline transcript; 28 patients were evaluable for MMR by 24 weeks....Deep Molecular Response (DMR) achievement rates were also encouraging. By 24 weeks, DMR was achieved in 22% of patients in the overall Phase 1b and 30% of patients in the 80 mg QD Phase 1b cohort."

P1 data • Chronic Myeloid Leukemia

Enliven Therapeutics…announced that the Company will host a webcast conference call on Thursday, June 11, 2026 at 8:30 a.m. ET to discuss updated data from the Phase 1 ENABLE clinical trial evaluating ELVN-001 in patients with previously treated chronic myeloid leukemia (CML) that will be presented at the European Hematology Association (EHA) 2026 Congress (PRNewswire)

P1 data • Chronic Myeloid Leukemia

Chronic myeloid leukemia: incorporation of recent advances into current treatment algorithms. (PubMed, Blood Cancer J) - "In patients experiencing failure of frontline therapy due to resistance or intolerance, multiple second- and third-line options are available, including second-generation TKIs, ponatinib, and asciminib, as well as novel investigational agents, including the ABL1 kinase domain inhibitors olverembatinib and ELVN-001 and the STAMP inhibitors TGRX-678 and TERN-701. In this review, we discuss the recent advances in the treatment of CML-CP and challenge some established management practices."

Journal • Review • Chronic Myeloid Leukemia • Hematological Malignancies • Leukemia • Oncology • ABL1

Enliven Therapeutics Inc. (NASDAQ:ELVN) announced today that updated data from its Phase 1 ENABLE trial of ELVN-001 for chronic myeloid leukemia will be presented at the European Hematology Association Congress on June 11 in Stockholm. (Investing.com) - "The abstract includes previously reported data showing a cumulative major molecular response rate of 47% in the initial 80 mg once-daily Phase 1b cohort, with 38% of patients achieving this response by 24 weeks. In patients who previously received asciminib, the cumulative response rate was 52%, with 38% achieving major molecular response by 24 weeks."

P1 data • Chronic Myeloid Leukemia

ELVN-001, a highly selective ATP-competitive ABL1 tyrosine kinase inhibitor for the treatment of chronic myeloid leukemia alone or in combination with asciminib (AACR 2025) - "While the active-site TKI ponatinib is active against T315I, its poor kinome selectivity limits its clinical utility. Finally, ENU mutagenesis screens were conducted in a Ba/F3 BCR-ABL1 line with ELVN-001 and asciminib, alone and in combination. Results of these studies and their impact on the clinical utility of this combination will be discussed."

Combination therapy • Chronic Myeloid Leukemia • Hematological Malignancies • Leukemia • Oncology • ABL1 • BCR • FLT3 • KDR • KIT

ELVN-001-101: A Phase 1a/1b Study of ELVN-001 for the Treatment Chronic Myeloid Leukemia (clinicaltrials.gov) - P1 | N=250 | Recruiting | Sponsor: Enliven Therapeutics | Trial completion date: Dec 2026 ➔ Dec 2027 | Trial primary completion date: Dec 2026 ➔ Dec 2027

First-in-human • Trial completion date • Trial primary completion date • Chronic Myeloid Leukemia • Hematological Malignancies • Leukemia • Oncology • ABL1 • BCR

Expected 2026 Clinical Milestones for ELVN-001 (PRNewswire) - "Mid-year presentation of additional Phase 1 data from the ongoing ENABLE trial; Regulatory alignment with the FDA on dose selection and Phase 3 trial design; Initiation of ENABLE-2, the Phase 3 clinical trial of ELVN-001, in the second half of 2026."

Clinical protocol • New P3 trial • P1 data • Chronic Myeloid Leukemia

Enliven Reports Positive Initial Phase 1b Data for ELVN-001 in CML… (PRNewswire) - "As of the cutoff date of December 22, 2025, 60 patients were enrolled in the initial cohorts of the Phase 1b trial...In the 80 mg QD Phase 1b cohort (n=19), all patients were evaluable for efficacy by 24 weeks. In these mature data, rates of MMR achievement (38%) and DMR (16%) compare favorably to precedent Phase 1 trials of approved BCR::ABL1 TKIs, including asciminib; In the randomized 60 mg and 120 mg cohorts (n=41), 26 patients were evaluable for efficacy by 24 weeks, reflecting their more recent enrollment. In this cohort, highly encouraging rates of MMR achievement (53%) and DMR (35%) were observed."

P1 data • Chronic Myeloid Leukemia

Preliminary safety and efficacy of ELVN-001, a selective active site inhibitor of BCR::ABL1, in patients with CML driven by atypical fusion transcripts (ASH 2025) - P1 | "Thepatient discontinued prior imatinib and nilotinib due to lack of efficacy, had a concurrent diagnosis ofMDS (treated with dasatinib plus azacitidine), a prior allogeneic myeloablative stem cell transplant, andwas last treated with asciminib (discontinued due to lack of efficacy)...The patient discontinued prior nilotinib, dasatinib,ponatinib, asciminib and a combination of asciminib and ponatinib due to lack of efficacy...ELVN-001 demonstrated encouraging anti-CML activity in patients with atypical transcripts, including inpatients with the e13a3 transcript, which is resistant to TKIs targeting the myristoyl pocket."

Clinical • Chronic Myeloid Leukemia • ABL1

CARDINAL: A Phase 1 study of TERN-701, a novel investigational allosteric BCR::ABL1 inhibitor for patients with previously treated CML (ASH 2025) - P1 | "Herewe report initial results from the ongoing Phase 1 study of TERN-701 in pts with previously treated CML-CP. CARDINAL (NCT06163430) is an ongoing, open-label, two-part, global, multicenter Phase 1study in pts ≥18 years old with BCR::ABL1-positive CML-CP (with or without T315I mutation and withoutmyristoyl binding pocket mutations) previously treated with ≥1 prior second-generation (2G) TKI(bosutinib, dasatinib, or nilotinib)...Baseline characteristics included: median 3 prior TKIs (range: 1‒6); 35% had ≥4 prior TKIs; 36% had prior asciminib; 25% had prior ponatinib and/or investigational TKI(olverembatinib/ELVN-001); 56% had baseline BCR::ABL1>1%, with 44% having baseline BCR::ABL1>10%; and 13% with BCR::ABL1 mutations (9% T315I, 4% F317L)... TERN-701 demonstrated encouraging safety/tolerability and efficacy in a heavily pre-treatedpatient population with CML-CP previously treated with approved 1G/2G TKIs, ponatinib, asciminib, andother investigational,..."

Clinical • P1 data • Chronic Myeloid Leukemia • Hematological Disorders • Hematological Malignancies • Leukemia • Neutropenia • Thrombocytopenia

"ENABLE: A Phase 1a/1b Study of ELVN-001, a selective active site inhibitor of BCR::ABL1, in patients with previously treated CML" (DGHO 2025) - P1 | "The majority of patients (66%) had received ≥3 prior TKIs, including ponatinib (45%) and asciminib (57%). ELVN-001 demonstrated favorable safety and tolerability across a wide range of doses, consistent with its selective kinase profile. Despite the heavily pretreated patient population, encouraging preliminary efficacy was observed."

Clinical • P1 data • Chronic Myeloid Leukemia • Hematological Disorders • Neutropenia • Pancreatitis • Thrombocytopenia • ABL1

Enliven Therapeutics Announces Clinical Data in CML Patients with Atypical Fusion Transcripts at ASH 2025 Annual Meeting (PRNewswire) - "As of the cutoff date of April 28, 2025, six patients with previously treated chronic phase CML who had an atypical transcript received ELVN-001 at doses from 20 mg to 80 mg twice daily (BID) in the dose escalation phase of the ENABLE study....Of the six enrolled patients with atypical transcripts, four patients had a baseline transcript available and thus could be assessed for efficacy. ELVN-001 demonstrated encouraging anti-CML activity in patients with atypical transcripts, including in patients with the e13a3 transcript, which is resistant to TKIs targeting the myristoyl pocket."

P1 data • Chronic Myeloid Leukemia

A study to evaluate safety, tolerability and pharmacokinetics of ELVN-001 in Normal Healthy Participants- Part A (ANZCTR) - P1 | N=15 | Completed | Sponsor: Enliven Therapeutics, Inc. | Not yet recruiting ➔ Completed

Trial completion • Chronic Myeloid Leukemia • CNS Disorders • Hematological Malignancies • Leukemia • Movement Disorders • Oncology • Parkinson's Disease

A study to evaluate safety, tolerability and pharmacokinetics of ELVN-001 in Normal Healthy Participants- Part B (ANZCTR) - P1 | N=15 | Completed | Sponsor: Enliven Therapeutics, Inc. | Not yet recruiting ➔ Completed

Trial completion • Chronic Myeloid Leukemia • CNS Disorders • Hematological Malignancies • Leukemia • Movement Disorders • Oncology • Parkinson's Disease

Management of chronic myeloid leukemia in 2025. (PubMed, Cancer) - "Today, the six approved BCR::ABL1 TKIs, five in frontline therapy (imatinib, dasatinib, bosutinib, nilotinib, and asciminib) and all six in later line therapy (including ponatinib), fulfill in one form or another these requirements. Third-generation TKIs that target the ABL1 kinase domain (olverembatinib and ELVN-001) or the myristoyl pocket (TGRX-678 and TERN-701) are under development...However, serious complications, such as graft-vs-host disease, or death could occur. This review summarizes relevant information concerning the management of CML in 2025, and addresses some CML treatment pathways that became entrenched in the management of CML in the first 15-20 years of TKI experience, which may need to be revisited."

Journal • Review • Bone Marrow Transplantation • Chronic Myeloid Leukemia • Graft versus Host Disease • Hematological Malignancies • Immunology • Leukemia • Oncology • Transplantation • ABL1

Enliven Therapeutics Announces Updated Positive Data from Phase 1 Clinical Trial of ELVN-001 in CML at EHA 2025 Congress (Yahoo Finance) - P1a/b | N=180 | ENABLE (NCT05304377) | Sponsor: Enliven Therapeutics | "Enliven Therapeutics, Inc...announced updated, positive data from the Phase 1 ENABLE clinical trial evaluating ELVN-001 in patients with chronic myeloid leukemia (CML) in an oral presentation at the European Hematology Association (EHA) 2025 Congress taking place June 12-15 in Milan, Italy, and virtually....25 of 53 (47%) evaluable patients were in MMR by 24 weeks, with 13 of 41 (32%) achieving and 12 of 12 (100%) maintaining MMR. Of those resistant to their last TKI, 14 of 34 (41%) were in MMR by 24 weeks. Of those previously treated with asciminib or ponatinib, 12 of 34 (35%) were in MMR by 24 weeks. All patients who achieved or maintained MMR were still in MMR at the time of data cutoff."

P1 data • Chronic Myeloid Leukemia

Enliven Therapeutics Announces Updated Positive Data from Phase 1 Clinical Trial of ELVN-001 in CML and Oral Presentation at the EHA 2025 Congress (PRNewswire) - P1 | N=180 | ENABLE (NCT05304377) | Sponsor: Enliven Therapeutics | "As of the cutoff date of January 21, 2025, 74 patients have been enrolled in the ongoing Phase 1 trial across dose levels from 10-160 mg daily and the vast majority of patients (82%) remain on study with a median treatment duration of ~26 weeks. Patients enrolled continue to be heavily pretreated, with 66% having received three or more prior tyrosine kinase inhibitors (TKIs), including ponatinib (45%) and asciminib (57%)....16 of 36 (44%) evaluable patients were in major molecular response (MMR) by 24 weeks, with 7 of 27 (26%) achieving and 9 of 9 (100%) maintaining MMR....ELVN-001 remains well-tolerated across all doses, consistent with its selective kinase profile....Dose interruptions and reductions occurred in less than 10% and less than 5% of patients, respectively."

P1 data • Chronic Myeloid Leukemia

Enliven Therapeutics Announces Poster Presentations at the 2025 AACR Annual Meeting (PRNewswire) - "Enliven Therapeutics...announced the Company will present five posters at the upcoming American Association for Cancer Research (AACR) Annual Meeting..."

Clinical data • Preclinical • Chronic Myeloid Leukemia • Solid Tumor

Enliven Therapeutics Reports Fourth Quarter and Full Year 2024 Financial Results and Provides a Business Update (PRNewswire) - "Recent Research and Development Highlights and Upcoming Milestones: ELVN-001...(i) The U.S. Food and Drug Administration (FDA) granted orphan drug designation to ELVN-001 for the treatment of chronic myeloid leukemia (CML); (ii) The first patient was dosed in the Phase 1 trial evaluating ELVN-001 in Japanese patients with CML (NCT06787144); (iii) The Company plans to report additional data from the ongoing Phase 1a/b trial in the middle of 2025."

Orphan drug • P1 data • Trial status • Chronic Myeloid Leukemia