Cosela (trilaciclib) / Simcere, Pharmacosmos, Menarini - LARVOL DELTA

Myeloprotective efficacy of trilaciclib combined with chemotherapy across solid tumor types: a real-world retrospective study (ESMO 2026) - No abstract available

Real-world • Real-world evidence • Retrospective data • Oncology • Solid Tumor

Exploratory study of the myeloprotective effect, safety, and efficacy of trilaciclib in conventional chemotherapy for bone and soft tissue sarcomas bone and soft tissue sarcoma, BSTS (ESMO 2026) - No abstract available

Clinical • Oncology • Sarcoma • Soft Tissue Sarcoma • Solid Tumor

Characterizing Neuroendocrine Lineage Plasticity Following Radiotherapy in Small Cell Lung Cancer (ASTRO 2026) - "CRISPR/Cas9-mediated knockout of Lats1 or Ccnd1, along with pharmacologic CDK4/6 inhibition using Trilaciclib, was employed for functional validation and pathway interrogation... Radiotherapy promotes neuroendocrine lineage plasticity in SCLC via the Hippo–YAP1–CCND1–EMT axis, driving evolution toward a non-NE, mesenchymal state and contributing to recurrence and metastasis. Targeting this pathway may restrain post-RT tumor progression."

Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor • ASCL1 • CCND1 • LATS1 • RB1 • TEAD1 • YAP1

Trilaciclib for the prevention of myelosuppression in locally advanced cervical cancer receiving induction chemotherapy plus concurrent chemoradiotherapy: Results of a prospective phase II trial (ESMO 2026) - No abstract available

Clinical • Metastases • P2 data • Cervical Cancer • Oncology • Solid Tumor

Trilaciclib for myeloprotection in limited-stage small cell lung cancer receiving first-line chemotherapy with sequential thoracic radiotherapy: an exploratory non-randomized controlled study (ESMO 2026) - No abstract available

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

An exploratory study of Trilaciclib for the primary prevention of hematologic toxicity events in neoadjuvant chemotherapy for borderline resectable and locally advanced pancreatic cancer (ChiCTR) - P4 | N=33 | Not yet recruiting | Sponsor: Huashan Hospital, Fudan University; Huashan Hospital, Fudan University

New P4 trial • Neutropenia • Oncology • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma • Solid Tumor

Real-World Outcomes of Trilaciclib in Preventing Chemotherapy-Related Myelosuppression for Unresectable NSCLC (IASLC-WCLC 2026) - "All patients received intravenous trilaciclib (240 mg/m2) 4 h prior to the administration of chemotherapy..The primary endpoint was the occurrence of grade ≥3 neutropenia during induction period. Secondary endpoints included antitumor efficacy (PFS/ORR/DOR/OS),myeloprotection effects (Grade≥3 thrombocytopenia, anemia, etc)."

Clinical • Real-world • Real-world evidence • Hematological Disorders • Lung Cancer • Neutropenia • Non Small Cell Lung Cancer • Solid Tumor • Thrombocytopenia

Adaptive mechanisms and emerging cancer therapeutics for CDK2 inhibitors. (PubMed, Nat Chem Biol) - "The approvals of four CDK4/6 (cyclin-dependent kinases 4 and 6) inhibitors by the US Food and Drug Administration-palbociclib, abemaciclib, ribociclib and trilaciclib-as anticancer or supportive therapies establish the critical role of CDKs in regulating the cell cycle and cancer progression. CDK2, the key kinase activated downstream of CDK4/6, has emerged as a prominent pharmaceutical target, with numerous selective inhibitors reported in recent years. This Perspective discusses the adaptive plasticity of cell-cycle control in cancer cells and then highlights current strategies to target newly emerging CDK2 druggable pockets-including orthosteric, substrate-binding and allosteric sites-with an emphasis on chemical biology approaches, aiming to inspire the next generation of CDK2 inhibitors and kinase-targeted therapies more broadly."

Journal • Review • Oncology • CDK4

Pharmacosmos A/S withdrew its application for a marketing authorisation of Zinmyleo, a medicine for reducing myelosuppression (damage to the bone marrow) caused by chemotherapy in patients undergoing certain treatment for extensive-stage small-cell lung cancer. (European Medicines Agency) - "The company withdrew the application on 22 July 2026."

European regulatory • Small Cell Lung Cancer

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 | Trial completion date: Mar 2027 ➔ Aug 2027 | Trial primary completion date: Sep 2026 ➔ Aug 2027

Trial completion date • Trial primary completion date • Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • HER-2 • PD-L1

A Single-arm, Multi-center, Phase II Exploratory Clinical Study to Evaluate the Efficacy and Safety of Trilaciclib in Preventing Myelosuppression Caused by Topoisomerase I Inhibitor Type ADC Drugs (clinicaltrials.gov) - P=N/A | N=96 | Not yet recruiting | Sponsor: Tianjin Medical University Cancer Institute and Hospital

New trial • Neutropenia • Oncology

Trilaciclib for Myeloprotection During Induction and Maintenance in ES-SCLC (OncLive) - "Dr. Sands notes he doesn't commonly use trilaciclib, finding the mechanism interesting given SCLC's near-universal RB1 and p53 loss, meaning trilaciclib protects normal cells from chemotherapy toxicity without affecting cancer cell division (unlike CDK4/6 inhibitors in breast cancer that arrest cancer cell cycling). Dr. Shields highlights that trilaciclib's patient-reported outcomes data revealed reduced fatigue compared to placebo, suggesting chemotherapy-associated anemia significantly contributes to fatigue burden beyond expected baseline levels. She anticipates expanding trilaciclib use as antibody-drug conjugates causing cytopenias enter SCLC treatment, with ongoing studies examining trilaciclib in limited-stage disease with concurrent chemoradiotherapy, including an Emory-conducted safety study combining trilaciclib with radiation."

Video

Menarini Asia-Pacific and Pharmacosmos partner to bring first-in-class oncology supportive care therapy Cosela to Asian patients (PRNewswire) - "Under the agreement, Menarini Asia-Pacific will manage all aspects of registration, reimbursement, commercialisation and distribution of Cosela in Australia, Hong Kong/Macau, Indonesia, Malaysia, New Zealand, Philippines, Singapore, South Korea, Taiwan, Thailand and Vietnam."

Licensing / partnership • Small Cell Lung Cancer

IFN γ and IFN γ mimetics prevent IFN-I-mediated TB susceptibility by regulating iron metabolism and lipid peroxidation. (PubMed, bioRxiv) - "Consistent with these predictions, the CDK4/6 inhibitor trilaciclib reduced lipid peroxidation by regulating iron metabolism, whereas retinoic acid signaling enhanced GPX4 expression and lipid biosynthesis programs. Combined CDK4/6 inhibition and retinoic acid receptor activation efficiently prevented the pathological activation state. Together, these findings delineate a mechanism of IFN-I/IFNγ crosstalk during macrophage activation and identify pharmacologic strategies to prevent IFN-I-dominant, lipid peroxidation-driven macrophage pathology."

Journal • Infectious Disease • Oncology • Pulmonary Disease • Respiratory Diseases • Tuberculosis • GPX4 • IFNG • TNFA

Myeloprotection effect of trilaciclib in lung cancer patients undergoing chemotherapy: a real-world retrospective study. (PubMed, J Thorac Dis) - "In a real-world cohort of patients with locally advanced or metastatic lung cancer receiving chemotherapy, trilaciclib was associated with a lower incidence of severe myelosuppression, reduced G-CSF utilization, and fewer hospitalizations. These findings should be considered exploratory, and may support the potential role of trilaciclib as a myeloprotective strategy to optimize treatment continuity and reduce healthcare burden."

Journal • Real-world evidence • Retrospective data • Alopecia • Immunology • Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor

A decade of progress in small-cell lung cancer (2015-2025): a narrative review. (PubMed, Eur J Clin Pharmacol) - "SCLC therapy has shifted from uniform cytotoxic treatment to a tiered, mechanism-driven algorithm that incorporates PD-L1 blockade, targeted cytotoxics, myeloprotection and refined radiotherapy, raising long-term survival above 20% in selected populations. From a European-practice perspective, current best practice is platinum-etoposide plus a PD-L1 inhibitor for treatment-naïve ES-SCLC, thoracic consolidation radiotherapy in selected responders, lurbinectedin or DLL3-directed clinical trials at relapse, and durvalumab consolidation after chemoradiation in LS-SCLC. Outstanding challenges include a low absolute survival gain from chemo-IO, the absence of validated predictive biomarkers, lineage plasticity, and unequal global access to new agents."

IO biomarker • Journal • Review • Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor • ASCL1 • DLL3 • NEUROD1 • POU2F3 • YAP1

Trilaciclib Combined With Immunochemotherapy for R/M HNSCC (clinicaltrials.gov) - P2 | N=32 | Not yet recruiting | Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

New P2 trial • Head and Neck Cancer • Neutropenia • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck

Cyclotherapy: exploiting cell-cycle decoupling for selective cancer cytotoxicity and normal-tissue protection. (PubMed, Cancer Treat Rev) - "More recently, the development of short-acting CDK4/6 inhibitors, particularly trilaciclib, has provided the first clinically approved example of pharmacologic myeloprotection in small-cell lung cancer...Cyclotherapy should not be regarded as a failed hypothesis prematurely tested, but as an evolving paradigm requiring refined biological stratification and temporal optimization. Properly implemented, it may redefine cytoprotection and expand the therapeutic latitude of modern oncology."

Journal • Review • Infectious Disease • Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor • RB1

Effect of Trilaciclib in the Prevention of Myelosupression in Subjects With Limited-stage Small Cell Lung Cancer (clinicaltrials.gov) - P3 | N=120 | Recruiting | Sponsor: Pharmacosmos A/S | Not yet recruiting ➔ Recruiting | Initiation date: Mar 2026 ➔ Jun 2026

Enrollment open • Trial initiation date • Lung Cancer • Neutropenia • Oncology • Small Cell Lung Cancer • Solid Tumor

Role of trilaciclib against chemotherapy‑induced myelosuppression: An updated systematic review and meta‑analysis. (ASCO 2026) - "Trilaciclib consistently eases the hematologic burden of chemotherapy and reduces supportive care needs, without an apparent trade-off in survival or response. Benefits are most robust in extensive-stage small-cell lung cancer; tumor-type heterogeneity warrants cautious extrapolation elsewhere."

Retrospective data • Review • Colorectal Cancer • Febrile Neutropenia • Leukopenia • Lung Cancer • Neutropenia • Small Cell Lung Cancer • Solid Tumor • Thrombocytopenia

Trilaciclib for myeloprotection in adjuvant and first-line chemotherapy for advanced gastric/gastroesophageal junction adenocarcinoma: A multicohort study. (ASCO 2026) - P4 | "Regimens included SOX/XELOX/FOLFOX ± immune checkpoint inhibitors (ICIs) ± trastuzumab... Trilaciclib demonstrated effective myeloprotection and immunoregulation in GA/GEJA, with PP showing a favorable trend. Grade ≥3 CIM rates were ≤5.88% (adjuvant) and ≤3.49% (metastatic), with no new safety signals. The studies will continue to analyze the correlation between immune-related indicators and anti-tumor efficacy."

Clinical • IO biomarker • Metastases • Febrile Neutropenia • Gastric Adenocarcinoma • Gastroesophageal Junction Adenocarcinoma • Neutropenia • Oncology • Solid Tumor • Thrombocytopenia • CD4 • CD8

APPROVED AND EMERGING OPTIONS FOR ONCOLOGY TREATMENT-RELATED TOXICITIES: A TARGETED LITERATURE REVIEW OF THE LANDSCAPE AND REMAINING UNMET NEEDS (ISPOR 2026) - "Agents were cataloged by intended use: (a) rescue therapies for acute overdose or early severe toxicity (e.g., glucarpidase, uridine triacetate, leucovorin rescue); (b) prophylactic organ-protective agents (e.g., mesna, amifostine, dexrazoxane, sodium thiosulfate, palifermin, trilaciclib); (c) countermeasures for immune-mediated toxicities (e.g., tocilizumab for cytokine release syndrome); and (d) radiation normal-tissue protectants in development (e.g., superoxide dismutase mimetics, avasopasem [GC-4419]). Across drug classes, agents demonstrated substantial clinical benefit in narrow, time-sensitive indications (e.g., rescue for high-dose methotrexate or fluoropyrimidine toxicity; cardioprotection with dexrazoxane; otoprotection with sodium thiosulfate in pediatric cisplatin-treated patients; and reduced mucositis with palifermin in select HSCT regimens)... Timely rescue administration can improve outcomes for patients experiencing severe treatment-related toxicities...."

Review • Bone Marrow Transplantation • Cardiovascular • Inflammation • Mucositis

In silico discovery of fructosamine-3-kinase inhibitors targeting the Nrf2-mediated antioxidant response in cancer cells: a molecular dynamics approach. (PubMed, In Silico Pharmacol) - "On the basis of 110 ns MD simulations, it was concluded that trilaciclib, tucatinib and olmutinib can be considered candidate inhibitors for HsFN3K inhibition. These drugs are expected to have favourable in-vitro and in-vivo activity inhibiting HsFN3K on the basis of our results. The online version contains supplementary material available at 10.1007/s40203-026-00635-2."

Journal • Oncology • NFE2L2

Trilaciclib for prophylaxis of chemotherapy-induced myelosuppression in solid tumor patients: a systematic review and meta-analysis. (PubMed, Front Pharmacol) - "Trilaciclib effectively prevents chemotherapy-induced myelosuppression in solid-tumor patients and can guide clinical use, but further well-designed studies are warranted to consolidate its efficacy and safety profile. https://www.crd.york.ac.uk/PROSPERO/, identifier CRD420251053232URL."

Journal • Retrospective data • Review • Fatigue • Febrile Neutropenia • Hematological Disorders • Neutropenia • Oncology • Solid Tumor

PROTECT-2: Trilaciclib in Patients Receiving Sacituzumab Tirumotecan for EGFR-mutated, Advanced Non-Small Cell Lung Cancer (NSCLC) (clinicaltrials.gov) - P2 | N=49 | Recruiting | Sponsor: The First Affiliated Hospital of Xiamen University | Not yet recruiting ➔ Recruiting | Trial completion date: May 2027 ➔ Dec 2027 | Initiation date: Jun 2025 ➔ Dec 2025 | Trial primary completion date: Jun 2026 ➔ Mar 2027

Enrollment open • Trial completion date • Trial initiation date • Trial primary completion date • Lung Cancer • Neutropenia • Non Small Cell Lung Cancer • Oncology • Solid Tumor