Cosela (trilaciclib) / Simcere, Pharmacosmos - LARVOL DELTA

Trilaciclib for the prevention of chemotherapy-induced myelosuppression: A systematic review and meta-analysis (ASH 2025) - "Chemotherapy regimens were heterogeneous and included etoposide-platinum (E/P) (either cisplatin or carboplatin) (n=5), gemcitabine/carboplatin (GCb) (n=2), topotecan (n=2), FOLFOXIRI (n=1), and Carboplatin/Paclitaxel/Tislelizumab (n=1)...It also showed a positive impact on progression-free and overall survival, without compromising chemotherapy effectiveness or increasing toxicity. These findings highlight Trilaciclib's potential as a valuable adjunct to chemotherapy in appropriately selected patients."

Retrospective data • Review • Breast Cancer • Colorectal Cancer • Febrile Neutropenia • Infectious Disease • Lung Cancer • Neutropenia • Non Small Cell Lung Cancer • Small Cell Lung Cancer • Solid Tumor • Thrombocytopenia • Triple Negative Breast Cancer

CDK4/6 inhibition mitigates chemotherapy-induced expansion of TP53-mutant clonal hematopoiesis (ASH 2025) - "We hypothesized that by protecting HSPCs from the cytotoxic effects of chemotherapy,trilaciclib might also reduce the clonal expansion of TP53-mutant CH during chemotherapy.We obtained serial blood samples from healthy controls (n=176) and three placebo-controlledrandomized clinical trials of trilaciclib including patients with (1) SCLC (n=65) receiving carboplatin andetoposide, (2) metastatic colorectal cancer (mCRC) (n=125) receivingleucovorin/fluorouracil/oxaliplatin/irinotecan (FOLFOXIRI) plus bevacizumab, and (3) metastatic triplenegative breast cancer (mTNBC) (n=34) receiving gemcitabine and carboplatin...Similar effectswere seen with the oral CDK4/6 inhibitor palbociclib and using a dominant negative form of CDK6introduced into p53 mutant HSPCs.Single cell RNA-seq of chimeric mice treated with carboplatin with trilaciclib or single agent controlsrevealed that CDK4/6 inhibition treatment promotes HSC and myeloid progenitor quiescence whilemitigating the myeloid..."

Breast Cancer • Colorectal Cancer • Eye Cancer • Hematological Malignancies • Lung Cancer • Retinal Disorders • Retinoblastoma • Small Cell Lung Cancer • Solid Tumor • Triple Negative Breast Cancer • PTPRC • TP53

A prospective, single-arm phase II study of trilaciclib combined with immunotherapy and chemotherapy as first-line treatment for metastatic/recurrent esophageal squamous cell carcinoma. (ASCO-GI 2026) - "The full, final text of this abstract will be available on Jan 05 at 05:00 PM EST."

Clinical • Metastases • P2 data • Esophageal Cancer • Esophageal Squamous Cell Carcinoma • Gastrointestinal Cancer • Oncology

Health-related quality of life with Trilaciclib in patients with advanced carcinoma [WITHDRAWN] (ESMO Asia 2025) - No abstract available

Clinical • HEOR • Metastases • Oncology

NUAK2 is a therapeutically tractable regulator of RNA splicing and tumor progression in neuroendocrine prostate cancer. (PubMed, bioRxiv) - "The FDA-approved CDK4/6 inhibitor trilaciclib exerts potent inhibition of NUAK2, leading to marked tumor suppression alone and enhanced efficacy in combination with carboplatin. As proof of principle, we validated that NUAK2 inhibition perturbs pre-mRNA splicing of EZH2 and TTK leading to reduced translation. Collectively, these findings establish NUAK2 as a clinically actionable regulator of RNA splicing and tumor progression in NEPC, revealing a novel mechanism by which trilaciclib exerts antitumor activity in NEPC."

Journal • Genito-urinary Cancer • Neuroendocrine Tumor • Oncology • Prostate Cancer • Solid Tumor

Safety and Efficacy of Antibody Drug Conjugate (ADCs) in Pretreated Locally Advanced/Metastatic (LA/m) Triple-Negative Breast Cancer (TNBC): Systematic Literature Review (SLR) (ISPOR-EU 2025) - P1/2, P2 | "Data was supplemented with relevant trial registries and conference proceedings. Seven trials were identified for LA/m TNBC patients previously treated with systemic anticancer therapy, with most of the trials evaluating patients with prior two lines of therapy: six for sacituzumab govitecan (SG), and one for enfortumab vedotin (EV)...One pivotal RCT (ASCENT) showed significant improvement of SG over chemotherapy (mPFS 4.8 vs 1.7 months; mOS 11.8 vs 6.9 months; 73% Grade ≥3 AEs; 5% discontinuations).Two SG single-arm combination studies (NCT04039230, PhII; NCT05113966, PII) reported mPFS of 6.2 months (SG+talazoparib) and 4.1 months (SG+trilaciclib), with mOS of 18.0 and 17.9 months, respectively... ADCs have demonstrated meaningful clinical benefits in pretreated LA/m TNBC, with varying safety profiles. Ongoing research into combination therapies and biomarker-driven patient selection is essential to optimize their integration into clinical practice."

Clinical • Metastases • Review • Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer

Case Report: Analysis of short-term clinical efficacy of trilaciclib in patients with advanced lung neuroendocrine carcinoma undergoing chemotherapy. (PubMed, Front Oncol) - "Studies have shown that more than 55% of patients with extensive-stage small cell lung cancer experience grade 3 or higher myelosuppression after receiving platinum/etoposide-containing chemotherapy, including neutropenia, anemia, and thrombocytopenia. In addition, the use of trilaciclib did not affect the anti-tumor effects of chemotherapy and immunotherapy agents during the chemotherapy cycle. This study aimed to explore the effect of trilaciclib on chemotherapy-induced myelosuppression (CIM) in patients with pulmonary neuroendocrine carcinoma undergoing chemotherapy, and to provide a reference for improving patients' treatment tolerance and quality of life in clinical practice."

Journal • Endocrine Cancer • Hematological Disorders • Infectious Disease • Lung Cancer • Neuroendocrine Carcinoma • Neutropenia • Non Small Cell Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor • Thrombocytopenia

Trilaciclib triggers a neutrophil-related immune response and sensitizes non-small cell lung cancer to anti-PD-1 therapy. (PubMed, Cell Rep Med) - "Additionally, activated CD8+ T cells recruit and activate neutrophils, forming a positive feedback loop. Combining trilaciclib with anti-PD-1 antibodies presents a promising strategy for NSCLC treatment."

Journal • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor • CD177 • CD8 • STING

A Prospective Phase II Clinical Study of Trilaciclib for Preventing Myelosuppression in Patients with Locally Advanced Nasopharyngeal Carcinoma, Esophageal Carcinoma, or Cervical Carcinoma Undergoing Induction Chemotherapy Combined with Concurrent Chemoradiotherapy or Concurrent Chemoradiotherapy (ChiCTR) - P2 | N=161 | Not yet recruiting | Sponsor: The First Affiliated Hospital, Air Force Medical University; The First Affiliated Hospital, Air Force Medical University

New P2 trial • Cervical Cancer • Esophageal Cancer • Head and Neck Cancer • Nasopharyngeal Carcinoma • Neutropenia • Oncology • Solid Tumor

A prospective, single-arm, exploratory Phase II clinical study to evaluate the efficacy and safety of Trilaciclib in the first-line treatment of locally advanced cervical cancer patients with paclitaxel combined with carboplatin and radiotherapy (ChiCTR) - P=N/A | N=30 | Not yet recruiting | Sponsor: Tianjin Cancer Hospital Airport Hospital; Tianjin Cancer Hospital Airport Hospital

New trial • Cervical Cancer • Neutropenia • Oncology • Solid Tumor

A Prospective, Multicenter, Single-arm Phase II Clinical Study to Evaluate the Efficacy and Safety of Trilaciclib in Patients with Locally Advanced Squamous Cell Lung Cancer Receiving Concurrent Chemoradiotherapy (ChiCTR) - P2 | N=32 | Not yet recruiting | Sponsor: West China Hospital of Sichuan University; West China Hospital of Sichuan University

New P2 trial • Lung Cancer • Lung Non-Small Cell Squamous Cancer • Neutropenia • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma

Efficacy and Safety of Trilaciclib in Myeloprotection during Chemotherapy for Pediatric Patients with Parameningeal Rhabdomyosarcoma with Meningeal Invasion (ChiCTR) - P4 | N=30 | Not yet recruiting | Sponsor: Beijing Children’s Hospital, Capital Medical University; Beijing Children’s Hospital, Capital Medical University

New P4 trial • Neutropenia • Oncology • Pediatrics • Rhabdomyosarcoma • Sarcoma • Solid Tumor

Phase II Clinical Trial of Trilaciclib in Combination With PD-1 Inhibitor and Chemotherapy as First-Line Treatment for (NSCLC) (IASLC-WCLC 2025) - P2 | "The primary endpoint was progression-free survival (PFS), and the key secondary endpoints were antitumor efficacy (ORR, DCR, OS, etc.) and bone marrow protection efficacy (incidence of grade 3 neutropenia during chemotherapy; Incidence of ≥ grade 3 thrombocytopenia; Incidence of grade 3 anemia, etc.), safety and tolerability. Methods : Medication plan is Trilaciclib 240mg/m 2 intravenously for 30 minutes and administered within 4 hours before chemotherapy; Pembrolizumab 200mg Q3W; Or Camrelizumab 200mg Q3W; Or Tislelizumab 200mg Q3W; Or Sintilimab 200mg Q3W; Or Toripalimab 240mg Q3W; Pemetrexed (non-squamous cell carcinoma) is 500mg/m 2 Q3W; Paclitaxel Albumin-bound (squamous cell carcinoma) is 260mg/m 2 Q3W; Carboplatin is AUC=5, up to 750mg Q3W; At present, this study has passed the Medical Ethics Committee of Liaoning Cancer Hospital, and has completed registration in the Chinese Clinical Trial Registry, The registration number is ChiCTR2500098340.It is expected..."

Clinical • Combination therapy • IO biomarker • P2 data • Anemia • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Neutropenia • Non Small Cell Lung Cancer • Solid Tumor • Squamous Cell Carcinoma • Thrombocytopenia

ToPCourT: Phase II Trial of Trilaciclib, Pembrolizumab, Gemcitabine and Carboplatin in Metastatic Triple-Negative Breast Cancer (clinicaltrials.gov) - P2 | N=36 | Active, not recruiting | Sponsor: Wake Forest University Health Sciences | Recruiting ➔ Active, not recruiting

Enrollment closed • Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • HER-2 • PD-L1

Targeting NUAK2 disrupts pre-mRNA splicing and inhibits neuroendocrine prostate cancer (PCF 2025) - "Pharmacological inhibition of NUAK2 using the preclinical compound HTH-02-006 or the FDA-approved CDK4/6 inhibitor G1T-28 (trilaciclib) which has off target NUAK2 activity suppresses NEPC growth in vitro and in vivo. NUAK2 inhibition had additive effects when combined with carboplatin in vivo... Collectively, these findings establish NUAK2 as a central regulator of RNA splicing and tumor growth in NEPC and provide strong rationale for therapeutic targeting of NUAK2 to improve outcomes in this lethal disease. Funding: This work was supported by the Department of Defense (DoD) Prostate Cancer Research Program (PCRP) Grant HT94252310125 (E.M.) and the DoD PCRP Early Investigator Research Award HT942524PCRPEIRA (U.M.). Acknowledgements: We thank the Duke Proteomics and Metabolomics Core Facility and the Department of Pathology at Duke University School of Medicine for their support."

Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

A single-arm, multi-cohort, phase II trial of evaluating myeloprotection with trilaciclib in adjuvant chemotherapy and first-line combination chemotherapy for gastric or gastroesophageal junction adenocarcinoma GAC/GEJAC Interim analysis (ESMO 2025) - P4 | "Regimens included SOX/XELOX/FOLFOX ± ICIs ± trastuzumab combined with trilaciclib (240 mg/m 2 on Days 1 and 3, Q3W for 6–8 cycles)...Conclusions Interim data indicate robust myeloprotection with trilaciclib in both adjuvant and advanced GAC/GEJAC, particularly with primary prophylaxis, and favorable safety profiles. Further enrollment and immunomodulatory analyses are ongoing to validate these findings and elucidate mechanisms of immune synergy."

Clinical • P2 data • Esophageal Cancer • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Oncology • Solid Tumor

Neoadjuvant trilaciclib plus chemotherapy and anti-PD1-antibody for locally advanced triple-negative breast cancer: Preliminary short-term efficacy and safety results from a single-arm, multicenter, phase II trial (ESMO 2025) - P2 | "Common treatment-related adverse events (TRAEs) were fatigue, nausea, alopecia, peripheral neurotoxicity, neutropenia, anemia and thrombocytopenia events; 46.4%, 17.5% and 14.3% of pts had grade 3/4 neutropenia, anemia and thrombocytopenia events. Conclusions Short-term efficacy and safety data are encouraging for Trilaciclib in combination with anti-PD1-antibody plus nab-paclitaxel and carboplatin in the neoadjuvant setting for locally advanced TNBC."

Clinical • Metastases • P2 data • Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • PD-L1

Preliminary results of a randomized phase II trial evaluating envafolimab, etoposide, and carboplatin with or without trilaciclib in ES-SCLC (ESMO 2025) - P2 | "Reduced severe hematologic toxicity in Cohort A supports trilaciclib's myelopreservation benefits. Ongoing follow-up will assess long-term outcomes."

Clinical • P2 data • Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor • IL10 • IL6

Myelopreservation effect of trilaciclib in extensive-stage small cell lung cancer (ES-SCLC): a systematic review and meta-analysis with trial sequential analysis of randomized clinical trials. (PubMed, Transl Lung Cancer Res) - "Our meta-analysis with TSA provided robust evidence that trilaciclib could significantly protect ES-SCLC patients receiving chemotherapies from myelosuppression, thereby enabling more consistent treatment administration and potentially enhancing clinical outcomes. However, more studies are necessary to clarify indirect outcomes."

Clinical • Journal • Retrospective data • Febrile Neutropenia • Hematological Disorders • Lung Cancer • Neutropenia • Oncology • Small Cell Lung Cancer • Solid Tumor

Myeloprotection with trilaciclib in hormone receptor (HR)-negative early breast cancer receiving adjuvant therapy (ESMO 2025) - P2 | "Cohort A received epirubicin/cyclophosphamide followed by weekly paclitaxel, while Cohort B received docetaxel/carboplatin/trastuzumab ± pertuzumab. Grade ≥3 diarrhea only occurred in 3.6% of Cohort B. No unexpected adverse events (AEs) of trilaciclib occurred. Conclusions The addition of trilaciclib prior to adjuvant chemotherapy in HR-negative early BC showed promising efficacy in improving CIM and reducing the need for associated supportive care."

Clinical • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Negative Breast Cancer • Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor • Triple Negative Breast Cancer • HER-2

Application value and safety of trilaciclib in first-line chemotherapy combined with immunotherapy for extensive-stage small cell lung cancer: A real-world study. (PubMed, Oncol Lett) - "The number of metastatic sites and treatment method were independent influencing factors for PFS, while ECOG score and baseline brain metastasis were independent poor prognostic factors for OS. In summary, trilaciclib is a potentially promising myeloprotective agent that improves PFS without compromising overall survival in patients with ES-SCLC."

Journal • Real-world evidence • Febrile Neutropenia • Hematological Disorders • Lung Cancer • Neutropenia • Oncology • Small Cell Lung Cancer • Solid Tumor • Thrombocytopenia

Efficacy and safety of trilaciclib plus chemotherapy in metastatic triple-negative breast cancer: A systematic review and meta-analysis. (ASCOQLTY 2025) - "Trilaciclib significantly reduces chemotherapy-induced hematologic toxicities in mTNBC without negatively impacting antitumor efficacy. However, its effects on survival outcomes remain uncertain and warrant further investigation."

Metastases • Retrospective data • Review • Breast Cancer • Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor • Triple Negative Breast Cancer

Analysis of Short-Term Clinical Efficacy of Trilaciclib in Patients with Advanced Lung Neuroendocrine Carcinoma Undergoing Chemotherapy (Frontiers) - "The results of the study showed that the incidence of grade 3 or higher myelosuppression in patients using trilaciclib (a cyclin-dependent kinase 4/6 [CDK4/6] inhibitor) when receiving platinum-based chemotherapy was significantly lower than that in patients who did not use this drug. In addition, the use of trilaciclib did not affect the anti-tumor effects of chemotherapy and immunotherapy agents during the chemotherapy cycle."

Real-world • Real-world evidence • Neuroendocrine Carcinoma

Prevention of Myelosuppression Associated with Concurrent Chemoradiotherapy in Limited Stage Small Cell Lung Cancer (ASTRO 2025) - "The use of trilaciclib in LS-SCLC patients receiving concurrent chemoracidotherapy reduces the occurrence of SN, has a multiline myelosuppression protection, and does not increase the risk of chemotherapy."

Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor

Trilaciclib (G1T28) in Patients With Previously Treated Extensive Stage SCLC Receiving Topotecan Chemotherapy (clinicaltrials.gov) - P1/2 | N=123 | Completed | Sponsor: G1 Therapeutics, Inc. | Terminated ➔ Completed | Phase classification: P1b/2a ➔ P1/2

Phase classification • Trial completion • Lung Cancer • Neutropenia • Oncology • Small Cell Lung Cancer • Solid Tumor