INCB123667 / Incyte - LARVOL DELTA

Preliminary Efficacy of INCB123667 (CDK2 Inhibition) with Bevacizumab in Recurrent Epithelial Ovarian Cancer (rEOC) (ESMO 2026) - No abstract available

Clinical • Epithelial Ovarian Cancer • Oncology • Ovarian Cancer • Solid Tumor

A phase 3, double-blind, randomized, controlled study of INCB123667 with bevacizumab versus bevacizumab alone as first-line maintenance therapy for advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer overexpressing cyclin E1 (MAESTRA 3; GOG-3146; ENGOT-OV106) (ESMO 2026) - No abstract available

Clinical • Metastases • P3 data • Fallopian Tube Cancer • Oncology • Ovarian Cancer • Peritoneal Cancer • Solid Tumor • CCNE1

MAESTRA 3: Phase 3 Study of INCB123667 Plus Bevacizumab Versus Bevacizumab Alone as First-Line Maintenance Therapy in Ovarian Cancer Overexpressing Cyclin E1 (clinicaltrials.gov) - P3 | N=590 | Not yet recruiting | Sponsor: Incyte Corporation

New P3 trial • Fallopian Tube Cancer • Oncology • Ovarian Cancer • Peritoneal Cancer • Solid Tumor • BRCA • CCNE1

Association of ctDNA Dynamics and Tumor Mutational Profiles With Clinical Outcomes in Recurrent Metastatic Epithelial Ovarian Cancer Patients Treated With CDK2 inhibitor in INCB123667-101 (EORTC-NCI-AACR 2026) - "Abstract will be available as of 4 November (with consent of the author)"

Circulating tumor DNA • Clinical • Clinical data • Metastases • Epithelial Ovarian Cancer • Oncology • Ovarian Cancer • Solid Tumor

Safety and tolerability of INCB123667, a selective CDK2 inhibitor, in patients (pts) with advanced solid tumors: A phase I study (ESMO 2024) - P1 | "INCB123667 was generally well tolerated with promising antitumor activity in pts with cyclin E1 overexpressing or CCNE1 amplified advanced/metastatic solid tumors. Dose expansion is ongoing in 6 tumor-specific cohorts. Evaluation of INCB123667 combination tx has been planned."

Clinical • Metastases • P1 data • Breast Cancer • Oncology • Ovarian Cancer • Solid Tumor • Triple Negative Breast Cancer • CCNE1

Safety and preliminary efficacy from a phase 1 study of INCB123667, a selective CDK2 inhibitor, in patients with advanced platinum-resistant and refractory ovarian cancer (OC). (ASCO 2025) - P1 | "In this phase 1 study of pts with heavily pretreated advanced/metastatic platinum-r/r OC, single agent INCB123667 at various doses showed an acceptable safety profile including expected cytopenia and nausea. The encouraging antitumor activity in this difficult-to-treat population support the advancement of INCB123667 into pivotal studies in pts with platinum-resistant OC."

Clinical • Metastases • P1 data • Platinum resistant • Anemia • Gastrointestinal Disorder • Neutropenia • Oncology • Ovarian Cancer • Refractory Ovarian Cancer • Solid Tumor • Thrombocytopenia • CCNE1

A Phase 3 study evaluating INCB123667 in first-line maintenance ovarian cancer is expected to initiate in the second half of 2026. (Businesswire)

New P3 trial • Ovarian Cancer

Incyte Data to Be Highlighted in Four Rapid Oral Presentations at the European Society for Medical Oncology (ESMO) Congress 2026 Support Efforts to Improve Outcomes in Difficult-to-Treat Cancers (Incyte Press Release) - "Rapid oral presentations will highlight new Phase 1 data across Incyte’s solid tumor portfolio; Both INCB161734, an investigational, potent, selective and orally bioavailable KRAS G12D inhibitor, and INCA33890, a TGFβR2×PD-1 bispecific antibody, are being evaluated in ongoing Phase 3 programs as first-line treatments for patients with advanced pancreatic ductal adenocarcinoma (PDAC) and microsatellite stable (MSS) colorectal cancer, respectively."

First-in-human • P1 data • P3 data • Anal Squamous Cell Carcinoma • Colorectal Cancer • Epithelial Ovarian Cancer • Fallopian Tube Cancer • Pancreatic Ductal Adenocarcinoma • Peritoneal Cancer

A phase 3, randomized, open-label study of INCB123667 versus investigator's choice of chemotherapy in patients with platinum-resistant ovarian cancer with cyclin E1 overexpression (MAESTRA 2, ENGOT-OV95, GOG-3137). (ASCO 2026) - P3 | "Standard therapies include single-agent, non-platinum chemotherapy with or without bevacizumab (bev), and mirvetuximab soravtansine (mirv) for pts with folate receptor alpha (FRα)-positive HGSOC...Pts are randomized 1:1 to INCB123667 50 mg twice daily or ICC (weekly paclitaxel, pegylated liposomal doxorubicin, gemcitabine, or topotecan)...Additional secondary endpoints include safety and tolerability, duration of response, PFS and objective response by investigator assessment, and health-related quality of life. The first pt was enrolled in Dec 2025."

Clinical • P3 data • Platinum resistant • Epithelial Ovarian Cancer • Fallopian Tube Cancer • High Grade Serous Ovarian Cancer • Oncology • Ovarian Cancer • Peritoneal Cancer • Solid Tumor • CCNE1 • FOLR1

INCB 123667-101: Study of INCB123667 in Subjects With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=291 | Active, not recruiting | Sponsor: Incyte Corporation | Recruiting ➔ Active, not recruiting | N=604 ➔ 291

Enrollment change • Enrollment closed • Monotherapy • Breast Cancer • Endometrial Cancer • Esophageal Cancer • Gastric Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • HER-2

A Study to Assess the Safety and Pharmacokinetics of INCB123667 When Administered Orally to Adult Participants With Severe Renal Impairment or End Stage Renal Disease (clinicaltrials.gov) - P1 | N=16 | Recruiting | Sponsor: Incyte Corporation | Not yet recruiting ➔ Recruiting

Enrollment open • Chronic Kidney Disease • Nephrology • Renal Disease

A Study to Assess the Safety and Pharmacokinetics of INCB123667 When Administered Orally to Adult Participants With Moderate or Severe Hepatic Impairment (clinicaltrials.gov) - P1 | N=16 | Recruiting | Sponsor: Incyte Corporation | Not yet recruiting ➔ Recruiting

Enrollment open • Hepatitis C • Hepatology • Liver Failure

A Study to Evaluate the Effect of Food on the Single-Dose Pharmacokinetics and a Drug-Drug Interaction Evaluation of Itraconazole and Carbamazepine on INCB123667 When Administered Orally to Healthy Adult Participants (clinicaltrials.gov) - P1 | N=51 | Completed | Sponsor: Incyte Corporation | Recruiting ➔ Completed

Trial completion

MAESTRA 2: Study to Evaluate INCB123667 Versus Investigator's Choice of Chemotherapy in Participants With Platinum-Resistant Ovarian Cancer With Cyclin E1 Overexpression (clinicaltrials.gov) - P3 | N=286 | Recruiting | Sponsor: Incyte Corporation

New P3 trial • Platinum resistant • Oncology • Ovarian Cancer • Solid Tumor • FOLR1

MAESTRA 2: Study to Evaluate INCB123667 Versus Investigator's Choice of Chemotherapy in Participants With Platinum-Resistant Ovarian Cancer With Cyclin E1 Overexpression (clinicaltrials.gov) - P3 | N=466 | Recruiting | Sponsor: Incyte Corporation | N=286 ➔ 466

Enrollment change • Platinum resistant • Trial initiation date • Oncology • Ovarian Cancer • Solid Tumor • FOLR1

INCB123667: Initiation of P3 trial for 1L ovarian cancer in H2 2026 (Incyte) - Q1 2026 Results

New P3 trial • Gynecologic Cancers • Oncology • Ovarian Cancer

A Study to Assess the Safety and Pharmacokinetics of INCB123667 When Administered Orally to Adult Participants With Moderate or Severe Hepatic Impairment (clinicaltrials.gov) - P1 | N=16 | Not yet recruiting | Sponsor: Incyte Corporation

New P1 trial • Hepatitis C • Hepatology • Liver Failure

A Study to Assess the Safety and Pharmacokinetics of INCB123667 When Administered Orally to Adult Participants With Severe Renal Impairment or End Stage Renal Disease (clinicaltrials.gov) - P1 | N=16 | Not yet recruiting | Sponsor: Incyte Corporation

New P1 trial • Chronic Kidney Disease • Nephrology • Renal Disease

INCB123667-305: Phase 3 Study of INCB123667 Versus Investigator's Choice of Chemotherapy in Platinum Resistant Ovarian Cancer With Cyclin E1 Overexpression (clinicaltrialsregister.eu) - P2/3 | N=108 | Not yet recruiting | Sponsor: Incyte Corp.

New P2/3 trial • Platinum resistant • Oncology • Ovarian Cancer • Solid Tumor • FOLR1

MAESTRA 1: A Study of INCB123667 in Participants With Platinum-Resistant Ovarian Cancer With Cyclin E1 Overexpression (clinicaltrials.gov) - P2 | N=160 | Recruiting | Sponsor: Incyte Corporation

Platinum resistant • Trial initiation date • Oncology • Ovarian Cancer • Solid Tumor • FOLR1

INCB123667-203: Phase 2 Study of INCB123667 in Platinum-Resistant Ovarian Cancer With Cyclin E1 Overexpression (clinicaltrialsregister.eu) - P1/2 | N=29 | Recruiting | Sponsor: Incyte Corp.

New P1/2 trial • Platinum resistant • Oncology • Ovarian Cancer • Solid Tumor • CCNE1 • FOLR1

Key Business Updates (Businesswire) - "INCA033989 (mutCALR)...Based on the promising results, the Company plans to initiate registrational programs in ET and MF in mid-2026 and in the second half of 2026, respectively...Results from the Phase 1 trial evaluating INCB160058 in MPN patients with a JAK2V617F mutation are anticipated in the second half of 2026...The initiation of a Phase 3 study evaluating INCB123667 in first-line maintenance ovarian cancer is anticipated in 2026."

CALR • JAK2V617F • New trial • P1 data • Platinum resistant • Trial status • Essential Thrombocythemia • Myelofibrosis • Myeloproliferative Neoplasm • Ovarian Cancer

MAESTRA 2: Study to Evaluate INCB123667 Versus Investigator's Choice of Chemotherapy in Participants With Platinum-Resistant Ovarian Cancer With Cyclin E1 Overexpression (clinicaltrials.gov) - P3 | N=466 | Recruiting | Sponsor: Incyte Corporation | Not yet recruiting ➔ Recruiting

Enrollment open • Platinum resistant • Oncology • Ovarian Cancer • Solid Tumor • FOLR1

Incyte…Provides Updates on Key Clinical Programs (Businesswire) - "The Phase 1 data in patients with myelofibrosis (MF) as monotherapy and in combination with ruxolitinib are anticipated in the second half of 2025...A Phase 1 study evaluating JAK2V617Fi in MPNs is ongoing. Initial proof of concept data are anticipated in the first half of 2026...Incyte plans to initiate Phase 3 studies for its potentially first-in-class CDK2 inhibitor (INCB123667), in ovarian cancer in 2025 and is also evaluating INCB123667 in combination with other treatments; The Phase 3 study evaluating tafasitamab as first-line treatment for diffuse large B-cell lymphoma (DLBCL) is ongoing. The Phase 3 data are anticipated in the second half of 2025; The Phase 1 studies evaluating KRASG12D and TGFßR2×PD-1 in solid tumors are ongoing. Initial proof of concept data for both studies are anticipated in the second half of 2025."

Clinical data • JAK2V617F • New P3 trial • Diffuse Large B Cell Lymphoma • Myelofibrosis • Myeloproliferative Neoplasm • Ovarian Cancer • Solid Tumor

INCB123667-103: Study Assessing the Mass Balance, Pharmacokinetics, and Metabolite Profiles of a Single Oral Dose of [14C]-INCB123667 in Healthy Male Participants (clinicaltrials.gov) - P1 | N=9 | Completed | Sponsor: Incyte Corporation | Recruiting ➔ Completed

Trial completion