Kisqali (ribociclib) / Otsuka, Novartis, Astex Pharmaceuticals - LARVOL DELTA

Adjuvant ribociclib (RIB) + nonsteroidal aromatase inhibitor (NSAI) in patients (pts) with HR+/HER2− early breast cancer (EBC): NATALEE 6-y overall survival (OS) and efficacy outcomes (ESMO 2026) - No abstract available

Clinical • Late-breaking abstract • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • HER-2

BUB1 and CDK4/6 Dual Inhibition Increases Radiation Sensitivity in Glioblastoma, Lung Cancer, and Triple-Negative Breast Cancer. (PubMed, Biomedicines) - " GBM, LC, and TNBC cell lines were treated with BUB1 inhibitor BAY1816032, CDK4/6 inhibitors ribociclib and abemaciclib, and radiation. Persistent RPA32 Ser33 phosphorylation reflects ATR-dependent resection that requires BLM and EXO1 at later stages, supporting sustained resection and unresolved repair leading to increased cell death. Dual inhibition of BUB1 and CDK4/6 represents a promising therapeutic strategy for enhancing radiosensitivity in GBM, lung cancer, and TNBC, particularly in Rb-intact settings."

Journal • Brain Cancer • Breast Cancer • Glioblastoma • Lung Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • BUB1 • HRD • RAD51 • RPA2

The NASA (Neoadjuvant Ribociclib plus Aromatase Inhibitor) Trial: A randomized comparison versus chemotherapy in HR+/HER2- EBC (ESMO 2026) - No abstract available

Clinical • Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • HER-2

Chronotoxicity of Ribociclib: Dose-Dependent and Nocturnal QTc Prolongation Missed by Standard Daytime Monitoring (ESMO 2026) - No abstract available

Oncology

Outcomes and Toxicity of Concurrent CDK46 Inhibitor and Adjuvant Radiation Therapy in Early Breast Cancer (ASTRO 2026) - "Abemaciclib and radiotherapy appears to be better tolerated than ribociclib or dalpiciclib combined with radiotherapy. Although high grade hematologic toxicities were often observed, but most patients treated with abemaciclib did not modify their treatment during radiotherapy."

Clinical • Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor

CATTALYST: Real-World Characteristics of Patients (Pts) with HR+/HER2− Early Breast Cancer (EBC) Eligible for or Treated with Adjuvant Ribociclib (RIB) (ESMO 2026) - No abstract available

Clinical • Real-world • Real-world evidence • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • HER-2

Age-stratified post-hoc analysis of adverse drug events in patients with advanced breast cancer treated with ribociclib: Ribo-Age study (ESMO 2026) - No abstract available

Adverse events • Clinical • Metastases • Retrospective data • Breast Cancer • Oncology • Solid Tumor

Co-Inhibition of BUB1 and CDK4/6 Augments Radiation Response in TNBC, Glioblastoma, and Lung Cancer (ASTRO 2026) - "Materials/ Cell proliferation, clonogenic survival, and immunoblot analyses were conducted in GBM, TNBC, and LC cell lines treated with the BUB1 inhibitor BAY1816032, CDK4/6 inhibitors (ribociclib, abemaciclib), and radiation. Dual inhibition of BUB1 and CDK4/6 represents a promising therapeutic strategy for enhancing radiosensitivity and overcoming intrinsic or acquired resistance in aggressive solid tumors. These results support the development of combination approaches targeting complementary G1/S and G2/M cell-cycle nodes to improve radiotherapy efficacy and limit tumor adaptation."

Brain Cancer • Glioblastoma • Lung Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • BUB1 • CDK4 • RAD51

Expert consensus on management of ribociclib (RIB)-associated liver-related adverse events (AEs) in HR+/HER2− breast cancer: a modified Delphi panel (ESMO 2026) - No abstract available

Adverse events • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • HER-2

Treatment feasibility and outcomes of first-line ribociclib in older patients (≥70 years) with hormone receptor positive HER2 negative (HR+/HER2-) advanced breast cancer (aBC): the FACILE study (ESMO 2026) - No abstract available

Clinical • Metastases • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • HER-2

Comparison of overall survival (OS) and progression-free survival (PFS) of palbociclib versus ribociclib in patients with HR+/HER2- metastatic breast cancer (mBC): A real-world SONABRE study (ESMO 2026) - No abstract available

Clinical • Metastases • Real-world • Real-world evidence • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • HER-2

Health-related quality of life (HRQoL) in patients (pts) with HR+/HER2− early breast cancer (EBC) receiving adjuvant ribociclib (RIB) plus a nonsteroidal aromatase inhibitor (NSAI) vs NSAI alone: 5-y NATALEE subgroup analyses by nodal status and stage (ESMO 2026) - No abstract available

Clinical • HEOR • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • HER-2

Impact of early ribociclib (RIB) discontinuation on clinical outcomes in patients (pts) with HR+/HER2− EBC from the phase 3 NATALEE trial (ESMO 2026) - No abstract available

Clinical • Clinical data • P3 data • HER2 Positive Breast Cancer • Oncology • HER-2

A Randomized, Open-Label, Phase 3 Study Evaluating Efficacy and Safety of Gedatolisib with Endocrine Therapy (ET) and Palbociclib vs ET and Ribociclib as First-Line (1L) Treatment in Patients With HR-Positive (HR+) HER2-Negative (HER2-) Advanced Breast Cancer (ABC) (VIKTORIA-2) (ESMO 2026) - No abstract available

Clinical • Metastases • P3 data • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • HER-2

Longitudinal gut microbiome profiling during abemaciclib or ribociclib therapy in HR-positive/HER2-negative breast cancer (ESMO 2026) - No abstract available

Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • HER-2

Ribociclib plus endocrine therapy versus chemotherapy in patients with rapidly progressive HR+/HER2− advanced breast cancer: a multicenter phase II study with external controls (ESMO 2026) - No abstract available

Clinical • Metastases • P2 data • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • HER-2

Prolonged progression-free survival in patients with HR+ HER2- advanced breast cancer treated with ribociclib + endocrine therapy in the RIBANNA trial (ESMO 2026) - No abstract available

Clinical • Metastases • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • HER-2

Phase II Trial of Ribociclib Plus Letrozole in Women With Recurrent Low-Grade Serous Carcinoma of the Ovary, Fallopian Tube, or Peritoneum: A GOG Partners Trial (GOG 3026). (PubMed, J Clin Oncol) - "Ribociclib plus letrozole met the primary end point, achieving meaningful response rates and durable disease control in recurrent LGSOC. The safety profile was consistent with prior CDK4/6 inhibitor studies. This combination represents a therapeutic option in this rare and genomically distinct subtype."

Journal • P2 data • Breast Cancer • Fallopian Tube Cancer • Hematological Disorders • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Low Grade Serous Carcinoma • Neutropenia • Oncology • Ovarian Cancer • Ovarian Serous Adenocarcinoma • Solid Tumor • ER

Severe Delayed Ribociclib-Induced Liver Injury Despite Prolonged Drug Interruption (ACG 2026) - "She had been receiving ribociclib with letrozole & leuprolide since Oct 2025. Although hepatotoxicity from CDK4/6 inhibitors is recognized, progression after prolonged drug interruption is uncommon and warrants vigilant monitoring. Figure: Trend of Liver Function Tests and Bilirubin during Hospitalization Figure: Laboratory values during the admission"

Breast Cancer • Hepatitis B • Hepatology • HER2 Breast Cancer • HER2 Negative Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Immunology • Infectious Disease • Liver Failure • Pancreatitis • Solid Tumor • ER • HER-2 • PGR

Invasive Lobular Carcinoma With Metastasis to the Colon: An Oncologic Anomaly (ACG 2026) - "The patient was already receiving letrozole and ribociclib therapy, and was referred to surgical oncology. This case highlights the importance of having high clinical suspicion in a patient with ILC who has the presence of GI symptoms. No matter how nonspecific the symptoms may be, there could be an underlying metastatic lesion waiting to be discovered."

Breast Cancer • CNS Disorders • Colorectal Cancer • Constipation • Gastroenterology • Gastrointestinal Disorder • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • CDX2 • GATA3 • HER-2 • NKX2-1 • PAX8 • WT1

First-line CDK4/6 inhibitor treatment of HR-positive, HER2-negative metastatic breast cancer: real-world data from Ho Chi Minh City Oncology Hospital, Vietnam. (PubMed, Front Oncol) - "We conducted a retrospective cohort study enrolling 107 patients who received first-line ribociclib or palbociclib in combination with an aromatase inhibitor or fulvestrant at Ho Chi Minh City Oncology Hospital between March 1, 2021, and April 1, 2023. Treatment outcomes and safety profiles were consistent with those reported in pivotal clinical trials and real-world studies. These findings should be interpreted in light of the retrospective single-center design, modest sample size, non-randomized treatment allocation, and immature OS data."

Journal • Real-world evidence • Breast Cancer • Febrile Neutropenia • Hematological Disorders • HER2 Breast Cancer • HER2 Negative Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Neutropenia • Oncology • Solid Tumor • HER-2

Ribociclib (RIB) vs. palbociclib (PAL) in patients (pts) with hormone receptor-positive/HER2-negative/HER2-enriched (HR+/HER2-/HER2-E) advanced breast cancer (ABC): A head-to-head phase III study—HARMONIA SOLTI-2101/AFT-58. (ASCO 2023) - P3 | "HER2-E cohort will randomized pts 1:1 to RIB+ET (letrozole or fulvestrant) or PAL+ET. As per recent protocol amendment, BL cohort pts will be treated with paclitaxel plus tislelizumab, an anti PD-1 monoclonal antibody, pts may be offered to try RIB + ET first, and will remain eligible for paclitaxel + tislelizumab upon progression...HARMONIA will recruit in Spain (55 sites), Portugal (5), and US (35) within SOLTI & AFT network. Clinical trial information: NCT05207709."

Clinical • Head-to-Head • Metastases • P3 data • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • HER-2

LINC01871-Mediated Sensitivity to Cyclin-Dependent Kinase 4/6 Inhibitors in Human Breast Cancer. (PubMed, J Vis Exp) - "Sixty-two lncRNAs associated with predicted sensitivity to ribociclib and palbociclib were identified, and six core lncRNAs were selected. These findings identify LINC01871 as a candidate biomarker of sensitivity to CDK4/6 inhibitors and demonstrate its tumor-suppressive effects in breast cancer. Further clinical and mechanistic studies are required to validate its predictive value and therapeutic relevance."

Journal • Breast Cancer • HER2 Negative Breast Cancer • Oncology • Solid Tumor • LINC01871

CHARGE: Ribociclib&Belinostat In Patients w Metastatic Triple Neg Breast Cancer & Recurrent Ovarian Cancer w Response Prediction By Genomics (clinicaltrials.gov) - P1 | N=12 | Terminated | Sponsor: University of Utah | N=34 ➔ 12 | Trial completion date: Aug 2026 ➔ Sep 2025 | Recruiting ➔ Terminated; No accrual in one year

Enrollment change • Platinum resistant • Trial completion date • Trial termination • Breast Cancer • Oncology • Ovarian Cancer • Ovarian Serous Adenocarcinoma • Solid Tumor • Triple Negative Breast Cancer • HER-2

Baseline (BL) characteristics and efficacy endpoints for patients (pts) with node-negative (N0) HR+/HER2− early breast cancer (EBC): NATALEE trial. (ASCO 2024) - P3 | "Background: NATALEE assessed ribociclib (RIB) + non-steroidal aromatase inhibitor (NSAI) vs NSAI alone in pts with HR+/HER2− EBC at increased risk of recurrence, including pts with N0 disease, and showed a statistically significant invasive disease-free survival (iDFS) benefit... Pts with stage II/III HR+/HER2− EBC were randomized (R) 1:1 to RIB 400 mg/d (3 wk on/1 wk off for 36 mo) + NSAI (letrozole or anastrozole for ≥60 mo) or NSAI alone. Men and premenopausal women received goserelin... This analysis showed a consistent efficacy benefit and manageable safety profile of RIB + NSAI vs NSAI alone in pts with N0 disease in NATALEE. The 3y iDFS, DDFS, and DRFS rates in the control arm at this early follow-up underscore the risk of recurrence for the N0 subgroup. These findings support the use of RIB in pts with HR+/HER2− EBC at increased risk of recurrence, including pts with N0 disease."

Clinical • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • HER-2