vinorelbine tartrate / Generic mfg. - LARVOL DELTA

Treatment in Patients With Advanced Non-Small Cell Lung Carcinoma and Interstitial Lung Disease (clinicaltrials.gov) - P2 | N=108 | Not yet recruiting | Sponsor: Intergroupe Francophone de Cancerologie Thoracique

New P2 trial • Interstitial Lung Disease • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Pulmonary Disease • Respiratory Diseases • Solid Tumor • IFIH1

Zanidatamab (Zani) + chemotherapy (Chemo) for patients (Pts) with HER2-expressing metastatic breast cancer (mBC): Final results of a phase I trial (ESMO-BC 2025) - P1 | "We report the final analysis of a phase I trial of zani + chemo in pts with HER2-expressing mBC. Part 3 of the phase I trial (NCT02892123) evaluated zani + chemo (paclitaxel [pac], capecitabine [cap] or vinorelbine [vin]) or zani + cap + tucatinib (tuc) in pts with HER2-expressing mBC...Prior (>5% of pts) anti-HER2 therapies included trastuzumab (93%), T-DM1 (91%), pertuzumab (80%), lapatinib (24%), T-DXd (9%), tuc (9%), and neratinib (7%)... Zani + chemo had a manageable safety profile and good tolerability with promising antitumour activity and durable responses in heavily pretreated pts with HER2-expressing mBC. Among pts with HER2+ mBC with prior HER2-targeted regimens, adding zani to chemo showed encouraging PFS."

Clinical • Metastases • P1 data • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • HER-2

Ten-year overall survival in resectable stage-III NSCLC - Results of the randomized ESPATUE trial - Long-term survival and competing risk analysis. (PubMed, Eur J Cancer) - "ESPATUE-trial looked at surgery versus boost-radiochemotherapy following induction chemotherapy, consisting of three cycles of cisplatin 50 mg/m2 on days 1 and 8 and paclitaxel 175 mg/m2 on day 1 every 21 days, as well as concurrent chemoradiotherapy to 45 Gy given as 1.5 Gy twice daily, concurrent cisplatin 50 mg/m2 on days 2 and 9, and concurrent vinorelbine 20 mg/m2 on days 2 and 9 (Eberhardt et al, J Clin Oncol 2015). A competing-risk-of-deaths-analysis showed no relevant preference for one arm. Death from comorbidities and death from second lung cancer remain relevant long-term-risks."

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

Metronomic chemotherapy plus anti-PD-1 in metastatic breast cancer: a Bayesian adaptive randomized phase 2 trial. (PubMed, Nat Med) - P2 | "Patients (total n = 97) were randomized to receive (1) metronomic vinorelbine (NVB) monotherapy (n = 11), (2) NVB plus anti-PD-1 toripalimab (n = 7), (3) anti-angiogenic bevacizumab, NVB and toripalimab (n = 27), (4) conventional cisplatin, NVB and toripalimab (n = 26), or (5) metronomic cyclophosphamide, capecitabine, NVB and toripalimab (the VEX cohort) (n = 26). Together, the clinical and translational data of this study indicate that metronomic VEX chemotherapy combined with PD-1 blockade can be a treatment option in patients with breast cancer. ClinicalTrials.gov Identifier: NCT04389073 ."

Journal • Metastases • P2 data • Breast Cancer • Hematological Disorders • HER2 Breast Cancer • HER2 Negative Breast Cancer • HER2 Positive Breast Cancer • Neutropenia • Oncology • Solid Tumor • HER-2

A phase 1b open-label, dose-escalating study of safety and efficacy of disulfiram, copper and vinorelbine in advanced solid tumors. (PubMed, BMC Cancer) - No abstract available

Journal • P1 data • Oncology • Solid Tumor

Model-Based Meta-Analysis of Overall Survival in Vulnerable Platinum-Ineligible NSCLC Populations. (PubMed, CPT Pharmacometrics Syst Pharmacol) - P3 | "IPSOS (NCT03191786) is a Phase III trial comparing atezolizumab (atezo) monotherapy to single-agent chemotherapy (gemcitabine or vinorelbine) in patients with treatment-naïve locally advanced or metastatic NSCLC unsuitable for platinum-doublet chemotherapy...The literature search included patients who were chemotherapy-naïve, had advanced or metastatic NSCLC, were platinum-ineligible, ≥ 70 years or had ECOG ≥ 2, and were treated with single-agent paclitaxel, docetaxel, gemcitabine, pemetrexed, or vinorelbine...After adjusting for ECOG PS (the only significant covariate), the model-predicted HR for the IPSOS control arm relative to historical trials was 0.543 (95% CI: 0.435-0.677), and the HR for the IPSOS atezo monotherapy arm was 0.418 (95% CI: 0.335-0.522). Overall, the MBMA results support the benefit of atezo seen in the IPSOS trial."

Clinical • Journal • Retrospective data • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Fuzuloparib with or without apatinib in patients with HER2-negative metastatic breast cancer with germline BRCA1/2 mutations (FABULOUS): interim analysis of a multicentre, three-arm, open-label, randomised, phase 3 trial. (PubMed, Lancet Oncol) - P3 | "Fuzuloparib, either as monotherapy or in combination with apatinib, provided statistically significant improvements in progression-free survival compared with chemotherapy in patients with HER2-negative metastatic breast cancer with germline BRCA1/2 mutations, presenting as new treatment options."

Clinical • Journal • P3 data • P3 data: top line • Breast Cancer • Cardiovascular • Hematological Disorders • HER2 Breast Cancer • HER2 Negative Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Breast Cancer • Hypertension • Oncology • Septic Shock • Solid Tumor • BRCA1 • BRCA2 • HER-2

Treatment With Etirinotecan Pegol for Patients With Metastatic Breast Cancer and Brain Metastases: Final Results From the Phase 3 ATTAIN Randomized Clinical Trial. (PubMed, JAMA Oncol) - P3 | "Patients were randomized to receive etirinotecan pegol, 145 mg/m2, every 21 days or chemotherapy (eribulin, ixabepilone, vinorelbine, gemcitabine, paclitaxel, docetaxel, or nab-paclitaxel). However, this study represents one of the largest published trials dedicated to patients with breast cancer and BM and may help to inform further research. ClinicalTrials.gov Identifier: NCT02915744."

Clinical • Journal • P3 data • Breast Cancer • Oncology • Solid Tumor

A Phase III Study of SYS6010 Versus Chemotherapy in HER2-Negative, EGFR-Positive Recurrent or Metastatic Breast Cancer (clinicaltrials.gov) - P3 | N=400 | Not yet recruiting | Sponsor: CSPC Megalith Biopharmaceutical Co.,Ltd.

New P3 trial • Breast Cancer • HER2 Negative Breast Cancer • Oncology • Solid Tumor • EGFR • HER-2

AVIATOR/TBCRC045: A randomized phase II study of vinorelbine (N) + trastuzumab (H) alone or combined with avelumab (A) +/- utomilumab (U) in patients (pts) with HER2+ metastatic breast cancer (MBC) (NCT03414658) (SABCS 2023) - P2 | " Eligible pts had HER2+ MBC previously treated with H, pertuzumab (P), and T-DM1...All pts were previously treated with H, P, and T-DM1, and 17% had prior trastuzumab deruxtecan... This trial demonstrated significant improvement in PFS with addition of avelumab to NH among pts with heavily pre-treated HER2+ MBC. 4-1BB agonist did not improve PFS. To our knowledge, this is the first randomized trial to report results of chemo/H +/- ICI in HER2+ MBC."

Clinical • IO biomarker • Metastases • P2 data • Breast Cancer • HER2 Breast Cancer • Oncology • Solid Tumor • HER-2 • PD-L1

EmpowHER-303: A Study Comparing the Efficacy and Safety of Zanidatamab to Trastuzumab, Each in Combination With Physician's Choice Chemotherapy, for the Treatment of Participants With Metastatic HER2-positive Breast Cancer (clinicaltrials.gov) - P3 | N=550 | Recruiting | Sponsor: Jazz Pharmaceuticals | Trial completion date: Nov 2031 ➔ Oct 2030 | Trial primary completion date: Sep 2028 ➔ Apr 2028

Trial completion date • Trial primary completion date • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor

Brief Report: Post Hoc Validation of Platinum Ineligibility in NSCLC From the Phase III IPSOS Study. (PubMed, J Thorac Oncol) - P3 | "This subanalysis suggests that first-line treatment with atezolizumab provides long-term OS, consistent with the results from the ITT population, and a favorable safety profile compared with single-agent chemotherapy in the sPI population. Additionally, the selection criteria for platinum ineligibility from the sPI population may provide a structured approach for treatment selection in NSCLC in clinical practice."

Journal • P3 data • Retrospective data • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

EVER-132-002: Asian Study of Sacituzumab Govitecan (IMMU-132) in HR+/HER2- Metastatic Breast Cancer (MBC) (clinicaltrials.gov) - P3 | N=331 | Active, not recruiting | Sponsor: Gilead Sciences | Trial completion date: Dec 2025 ➔ Dec 2026 | Trial primary completion date: Dec 2025 ➔ Dec 2026

Trial completion date • Trial primary completion date • Breast Cancer • HER2 Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • HER-2

Sacituzumab Govitecan (SG) vs Treatment of Physician’s Choice (TPC): Efficacy by Trop-2 Expression in the TROPiCS-02 Study of Patients (Pts) With HR+/HER2– Metastatic Breast Cancer (mBC) (SABCS 2022) - "Pts were randomized 1:1 to receive SG (10 mg/kg IV on d 1 and 8, every 21 d) or TPC (eribulin, gemcitabine, capecitabine, or vinorelbine) until disease progression or unacceptable toxicity. In this TROPiCS-02 post-hoc analysis, improved efficacy with SG vs TPC was observed regardless of Trop-2 expression, and there was no clear level of Trop-2 expression at which a better treatment effect for SG was observed. These results support SG as an effective novel treatment option for patients with pretreated, endocrine- resistant HR+/HER2- mBC, and reinforce that Trop-2 testing is not required for SG treatment."

Clinical • Breast Cancer • HER2 Breast Cancer • Oncology • Triple Negative Breast Cancer • HER-2

Sacituzumab govitecan (SG) efficacy in hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2–) metastatic breast cancer (MBC) by HER2 immunohistochemistry (IHC) status in the phase III TROPiCS-02 study (ESMO 2022) - P3 | "Methods Pts with HR+/HER2– unresectable locally advanced or MBC and 2-4 prior chemotherapy regimens for MBC were randomized 1:1 to receive SG (10 mg/kg IV on d 1 and 8, every 21 d) or TPC (capecitabine, eribulin, vinorelbine, or gemcitabine) until unacceptable toxicity or disease progression. Conclusions Clinical benefit with SG vs TPC in HER2 IHC0 and HER2-Low HR+/HER2- MBC was consistent with that of the TROPiCS-02 ITT population. SG should be considered an effective treatment option for pts with HR+/HER2- MBC, regardless of HER2 status."

Clinical • P3 data • 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 • Triple Negative Breast Cancer • HER-2

Sacituzumab govitecan (SG) efficacy in patients with metastatic triple-negative breast cancer (mTNBC) by HER2 immunohistochemistry (IHC) status: Findings from the Phase 3 ASCENT study (ESMO-BC 2022) - P3 | "This ASCENT post hoc subgroup analysis evaluates SG efficacy in HER2 IHC0 and HER2-Low mTNBC.Methods Patients (pts) with mTNBC refractory/relapsing after ≥2 prior chemotherapies (≥1 in the metastatic setting) were randomized 1:1 to receive SG (10 mg/kg IV on d 1 and 8, every 21 d) or TPC (capecitabine, eribulin, vinorelbine, or gemcitabine) until unacceptable toxicity/progression. HER2-Low had numerically better outcomes vs HER2 ICH0 in both the SG and TPC arms.Conclusions Clinical benefit with SG in HER2 IHC0 and HER2-Low mTNBC was consistent with that of the ASCENT ITT population, regardless of HER2 status. SG should be considered an effective treatment option for pts with mTNBC eligible for 2L or later therapy."

Clinical • P3 data • Breast Cancer • HER2 Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • HER-2

Study to Assess Safety and Efficacy of Atezolizumab (MPDL3280A) Compared to Best Supportive Care Following Chemotherapy in Patients With Lung Cancer [IMpower010] (clinicaltrials.gov) - P3 | N=1280 | Active, not recruiting | Sponsor: Hoffmann-La Roche | Trial completion date: Dec 2027 ➔ Aug 2027

Trial completion date • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Biomarker Analyses in the Phase 3 ASCENT Study of Sacituzumab Govitecan Versus Chemotherapy in Patients with Metastatic Triple-Negative Breast Cancer. (PubMed, Ann Oncol) - "SG benefits patients with previously treated mTNBC expressing high/medium Trop-2 compared with standard-of-care chemotherapy and regardless of germline BRCA1/2 mutation status. The small number of patients with low Trop-2 expression precludes definitive conclusions on the benefit of SG in this subgroup."

Biomarker • Clinical • Journal • P3 data • Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • BRCA1 • BRCA2

Overall survival with sacituzumab govitecan in hormone receptor-positive and human epidermal growth factor receptor 2-negative metastatic breast cancer (TROPiCS-02): a randomised, open-label, multicentre, phase 3 trial. (PubMed, Lancet) - P3 | "Sacituzumab govitecan demonstrated statistically significant and clinically meaningful benefit over chemotherapy, with a 3·2-month median overall survival improvement and a manageable safety profile. These data support sacituzumab govitecan as a new treatment option for patients with pretreated, endocrine-resistant HR+ and HER2- metastatic breast cancer."

Journal • Metastases • P3 data • Breast Cancer • Fatigue • Gastroenterology • Gastrointestinal Disorder • HER2 Breast Cancer • HER2 Negative Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Immunology • Oncology • Septic Shock • Solid Tumor • HER-2

Sacituzumab govitecan (SG) versus treatment of physician’s choice (TPC) in patients (pts) with previously treated, metastatic triple-negative breast cancer (mTNBC): Final results from the phase 3 ASCENT study. (ASCO 2022) - P3 | " Pts with mTNBC refractory or relapsing after ≥2 prior chemotherapies with at least 1 in the metastatic setting were randomized 1:1 to receive SG (10 mg/kg IV on days 1 and 8, every 21 days) or TPC (capecitabine, eribulin, vinorelbine, or gemcitabine) until disease progression or unacceptable toxicity. The analysis based on the final database lock of ASCENT confirms the superior survival outcomes of SG over single-agent chemotherapy, with a manageable safety profile and improvement in QoL for pts with mTNBC in the 2L+ setting. These findings reinforce SG as an effective treatment option for this pt population."

Clinical • P3 data • Anemia • Breast Cancer • Febrile Neutropenia • Hematological Disorders • Infectious Disease • Interstitial Lung Disease • Neutropenia • Oncology • Pain • Pulmonary Disease • Respiratory Diseases • Septic Shock • Solid Tumor • Triple Negative Breast Cancer

Sacituzumab Govitecan in Metastatic Triple-Negative Breast Cancer. (PubMed, N Engl J Med) - P3 | "Progression-free and overall survival were significantly longer with sacituzumab govitecan than with single-agent chemotherapy among patients with metastatic triple-negative breast cancer. Myelosuppression and diarrhea were more frequent with sacituzumab govitecan. (Funded by Immunomedics; ASCENT ClinicalTrials.gov number, NCT02574455; EudraCT number, 2017-003019-21.)."

Journal • Breast Cancer • Hematological Disorders • Leukopenia • Neutropenia • Oncology • Solid Tumor • Triple Negative Breast Cancer • TROP2

Safety analyses from the phase 3 ASCENT trial of sacituzumab govitecan in metastatic triple-negative breast cancer. (PubMed, NPJ Breast Cancer) - "In the ASCENT study, patients with metastatic triple-negative breast cancer (mTNBC) relapsed/refractory to ≥2 prior chemotherapy regimens (≥1 in the metastatic setting), received SG or single-agent treatment of physician's choice (eribulin, vinorelbine, capecitabine, or gemcitabine). Patients with UGT1A1 *28/*28 genotype versus those with 1/*28 and *1/*1 genotypes had higher rates of grade ≥3 SG-related neutropenia (59% vs 47% and 53%), febrile neutropenia (18% vs 5% and 3%), anemia (15% vs 6% and 4%), and diarrhea (15% vs 9% and 10%), respectively. Individuals with UGT1A1 *28/*28 genotype should be monitored closely; active monitoring and routine AE management allow optimal therapeutic exposure of SG."

Journal • P3 data • Breast Cancer • Febrile Neutropenia • Hematological Disorders • Neutropenia • Oncology • Solid Tumor • Triple Negative Breast Cancer • UGT1A1

Primary results from TROPiCS-02: A randomized phase 3 study of sacituzumab govitecan (SG) versus treatment of physician’s choice (TPC) in patients (Pts) with hormone receptor–positive/HER2-negative (HR+/HER2-) advanced breast cancer. (ASCO 2022) - P3 | "Pts were randomized 1:1 to receive SG (10 mg/kg IV on d1 and 8, every 21d) or TPC (capecitabine, eribulin, vinorelbine, or gemcitabine) until disease progression/unacceptable toxicity. SG had a statistically significant, clinically meaningful PFS benefit over single-agent chemotherapy and a manageable safety profile in pts with heavily pre-treated HR+/HER2– endocrine-resistant, unresectable locally advanced or MBC, who have limited treatment options."

Clinical • Late-breaking abstract • P3 data • Breast Cancer • Hematological Disorders • HER2 Breast Cancer • HER2 Negative Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Neutropenia • Oncology • Solid Tumor • Triple Negative Breast Cancer • HER-2

PEMBROLIZUMAB PLUS GEMCITABINE, VINORELBINE, AND DOXORUBICIN FOLLOWED BY AUTOLOGOUS STEM CELL TRANSPLANTATION IN 24 RELAPSED/REFRACTORY CLASSICAL HODGKIN LYMPHOMA PATIENTS (EBMT 2026) - "Conditioning regimen was BeEAM (Bendamustine: 300 mg/m², Aracytine: 800 mg/m², Etoposide: 800 mg/m² and Melphalan: 140 mg/m²)...Brentuximab-vedotin maintenance was given in 9 pts (39%)... Currently, patients with R/R cHL receive salvage therapy with immune checkpoint inhibitors. Pembrolizumab-GVD prior to ASCT provides deep pre-transplant responses and excellent post-ASCT outcomes. This strategy increases transplant eligibility and supports a tailored approach incorporating post-ASCT consolidation."

Clinical • Bone Marrow Transplantation • Classical Hodgkin Lymphoma • Hematological Malignancies • Hodgkin Lymphoma • Lymphoma • Transplantation

Health-related quality of life (HRQoL) in the phase III TROPiCS-02 trial of sacituzumab govitecan (SG) vs chemotherapy in HR+/HER2- metastatic breast cancer (MBC) (ESMO 2022) - P3 | "Methods Patients (pts) with locally determined HR+/HER2- MBC following (2-4 prior chemotherapies) for metastatic disease, were randomized to receive SG (10 mg/kg IV on days 1 and 8 of a 21-day treatment [Tx] cycle) or TPC (capecitabine, eribulin, gemcitabine, or vinorelbine). Table: 1553O EORTC QLQ-C30 least-square mean change from baseline SG, sacituzumab govitecan; TPC, treatment of physician's choice. Conclusions Despite the association with worsening diarrhea, SG demonstrated an overall HRQoL benefit in heavily-pretreated patients with HR+/HER2- MBC."

Clinical • HEOR • P3 data • Breast Cancer • HER2 Breast Cancer • Oncology • Solid Tumor • HER-2