vinorelbine tartrate / Generic mfg. - LARVOL DELTA

sTEADfast: A Phase 3 Trial in Advanced Epithelioid Mesothelioma (clinicaltrials.gov) - P3 | N=350 | Not yet recruiting | Sponsor: Vivace Therapeutics, Inc

New P3 trial • Epithelioid Mesothelioma • Malignant Pleural Mesothelioma • Mesothelioma • Oncology • Pleural Mesothelioma • Solid Tumor

A Phase II Study of HLX22 in Combination With Trastuzumab and Chemotherapy in HER2-Positive Locally Advanced or Metastatic Breast Cancer Patients (clinicaltrials.gov) - P2 | N=90 | Not yet recruiting | Sponsor: Shanghai Henlius Biotech

New P2 trial • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • HER-2

High-grade gliomas H3G34-mutant in pediatric and AYA population: a single center experience (EANO 2026) - "First-line chemotherapy included Nimotuzumab/Vinorelbine regimen (NV) (3/12), NV plus Temozolomide (TMZ) (4/12), TMZ alone (3/12), and TMZ plus Bevacizumab (1/12).Best response included partial response in 3/12 and stable disease in 1/12...At progression, one patient received re-irradiation and NV; 4/8 received second-line strategies, including TMZ plus Regorafenib (1/4), TMZ plus sirolimus (1/4), Nivolumab (1/4) and Bevacizumab (1/4), with limited impact on long-term outcomes... Although limited in size, this case series underscores the poor prognosis of HGG G34 in pediatric and young adult patients, characterized by infiltrative growth, restricted surgical resectability, and suboptimal response to current treatment modalities. These findings highlight the urgent need for the development of novel therapeutic strategies and more effective molecularly targeted approaches to address this rare yet highly aggressive malignancy."

Clinical • Brain Cancer • Glioma • High Grade Glioma • Oncology • Solid Tumor • CHEK2 • MSH3 • NBN • POLD1

The NARLAL II trial: First results on loco-regional control in stage 3 NSCLC (ESTRO 2024) - P=N/A | "Background The survival and loco-regional control for patients with locally advanced NSCLC (LA-NSCLC) are dismal despite the introduction of adjuvant durvalumab...S118 Invited Speaker Concomitant chemotherapy was oral Navelbine®50 mg three times a week and cisplatin or carboplatin administered at weeks one and four...Dose escalation was determined safe in the pre-planned interim analyses. We are looking forward to present the data on the primary end point."

Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma

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

Association of 18-Gene Expression Profile (GEP) With Clinical Outcomes in Patients With Metastatic Triple-Negative Breast Cancer (mTNBC) Treated With Pembrolizumab (Pembro) or Chemotherapy (Chemo) in KEYNOTE-119 (ESMO-BC 2023) - P3 | "Methods Pts with centrally confirmed mTNBC, ECOG PS ≤1, and 1-2 prior systemic treatments for metastatic breast cancer were randomized 1:1 to pembro 200 mg Q3W for up to 35 cycles or TPC (capecitabine, eribulin, gemcitabine, or vinorelbine) per local guidelines. Conclusions These findings suggest a positive association between GEP and clinical outcomes in pts with mTNBC who are treated with pembro, with a more favorable treatment effect in the GEP-enriched population. Results may help inform future analyses of outcomes by biomarker status in this population."

Clinical • Clinical data • IO biomarker • Metastases • Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • BRCA • HRD • PD-L1

Updated Overall Survival and Exploratory Analysis From Randomized, Phase II EVAN Study of Erlotinib Versus Vinorelbine Plus Cisplatin Adjuvant Therapy in Stage IIIA Epidermal Growth Factor Receptor+ Non-Small-Cell Lung Cancer. (PubMed, J Clin Oncol) - "With erlotinib, a single-nucleotide polymorphism mutation in UBXN11 was associated with significantly worse DFS (P = .01). To our knowledge, this study is the first to demonstrate clinically meaningful OS improvement with adjuvant erlotinib compared with chemotherapy in R0 stage III EGFR+ non-small-cell lung cancer."

Journal • P2 data • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • EGFR • MUC16 • TP53 • UBXN11

SOLTI-1907 ATREZZO: Targeting hormonal receptor negative (HR-) or PAM50 non-luminal disease with atezolizumab in combination with trastuzumab and vinorelbine in HER2-positive metastatic breast cancer (MBC) (SABCS 2022) - P2 | "Background: Today, there is no clear therapeutic algorithm for patients with metastatic HER2- positive (HER2+) breast cancer (BC) who have progressed to trastuzumab, pertuzumab, tyrosine kinase inhibitors and antibody-drug conjugates (ADC). This study was funded by Roche Farma SA. Trial identification: NCT04759248"

Combination therapy • IO biomarker • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • HER-2 • TMB

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 in ER+/HER2- breast cancer: a necessary treatment option for patients who have undergone multiple prior treatments. (PubMed, Recenti Prog Med) - "Surgery was excluded, so she started CDK4/6 inhibitor and letrozole...Because of further skin and lymph node progression, the patient began everolimus and exemestane in July 2023...The patient started capecitabine and vinorelbine...In March 2025 she began sacituzumab govitecan (SG): after the first month, clinical examination revealed partial remission of subcutaneous nodules and pathological lymph nodes in the right axilla, gradually leading to cuff removal. The possibility to use SG in luminal breast cancer patients gave this woman a chance, in a scenario poor in exciting options."

Journal • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • ER • 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

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

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

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

innovaTV 301/ENGOT-cx12/GOG-3057: A global, randomized, open-label, phase III study of tisotumab vedotin vs investigator's choice of chemotherapy in 2L or 3L recurrent or metastatic cervical cancer (ESMO 2023) - P3 | "Pts were randomized 1:1 to TV monotherapy or investigator's choice of topotecan, vinorelbine, gemcitabine, irinotecan, or pemetrexed...63.9% and 27.5% of pts had prior bevacizumab and prior anti-PD-(L)1 therapy, respectively...AEs were consistent with the known TV safety profile, including for ocular, peripheral neuropathy, and bleeding AEs. Conclusions In the phase 3 innovaTV 301 study, TV showed a statistically significant and clinically meaningful improvement in OS, PFS, and ORR vs chemotherapy, with a manageable and tolerable safety profile in pts with 2L/3L r/mCC."

Clinical • Late-breaking abstract • Metastases • P3 data • Cervical Cancer • Oncology • Solid Tumor

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

Outcomes with first-line (1L) ribociclib (RIB) + endocrine therapy (ET) vs physician’s choice combination chemotherapy (combo CT) by age in pre/perimenopausal patients (pts) with aggressive HR+/HER2− advanced breast cancer (ABC): A subgroup analysis of the RIGHT Choice trial. (ASCO 2023) - P2 | " Pre/perimenopausal pts (aged 18-59 y) with HR+/HER2− ABC and no prior systemic therapy for ABC were randomized 1:1 to either RIB with letrozole/anastrozole + goserelin or investigator’s choice of combo CT (docetaxel + capecitabine, paclitaxel + gemcitabine, or capecitabine + vinorelbine). This analysis demonstrated a clinically meaningful PFS benefit and improved secondary outcomes with 1L RIB + ET over combo CT along with similar treatment responses in both tx arms in pts aged * Unconfirmed."

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

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

Randomized phase 3 study of datopotamab deruxtecan vs chemotherapy for patients with previously-treated inoperable or metastatic hormone receptor-positive, HER2-negative breast cancer: Results from TROPION-Breast01 (SABCS 2023) - P3 | "Pts were randomized 1:1 to Dato-DXd (6 mg/kg Q3W) or ICC (eribulin, vinorelbine, capecitabine, or gemcitabine) until progression or unacceptable toxicity. TROPION-Breast01 met its dual primary endpoint of PFS, demonstrating statistically significant and clinically meaningful improvement in PFS with Dato-DXd compared with ICC across all subgroups. Overall, the safety profile and QoL with Dato-DXd was favorable compared with ICC. These data support Dato-DXd as a potential new therapeutic option for pts with inoperable or metastatic HR+/HER2‒ BC who have received 1‒2 prior lines of CT."

Clinical • 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

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

Final results of RIGHT Choice: Ribociclib plus endocrine therapy vs combination chemotherapy in premenopausal women with clinically aggressive HR+/HER2- advanced breast cancer. (PubMed, J Clin Oncol) - "In this open-label, multi-center, randomized phase 2 trial, pre/perimenopausal women with clinically aggressive HR+/HER2- ABC were randomized 1:1 to first-line ribociclib (600 mg daily; 3-weeks-on, 1-week-off) plus letrozole/anastrozole and goserelin or investigator's choice of combination CT (docetaxel plus capecitabine, paclitaxel plus gemcitabine, or capecitabine plus vinorelbine). Lower rates of symptomatic adverse events were observed in the ribociclib versus CT arm. First-line ribociclib plus ET showed a significant PFS benefit, similar response rates, and better tolerability over combination CT in patients with clinically aggressive HR+/HER2- ABC."

Journal • 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

InDuRanS: Randomized phase II study of induction immunochemotherapy followed by surgery or chemoradiation and consolidation with durvalumab in stage III NSCLC (DGT 2026) - P2 | "InDuRanS is the first prospective randomized study directly comparing surgery and definitive RCT after durvalumab-based induction therapy in patients with (borderline) resectable stage III NSCLC, with the aim of defining optimal multimodal strategies in the current therapeutic landscape."

Clinical • P2 data • Surgery • Lung Cancer • Non Small Cell Lung Cancer • Solid Tumor • EGFR

Sacituzumab tirumotecan (SKB264/MK-2870) in patients (pts) with previously treated locally recurrent or metastatic triple-negative breast cancer (TNBC): Results from the phase III OptiTROP-Breast01 study. (ASCO 2024) - P3 | "Sacituzumab tirumotecan (SKB264/MK-2870) is a TROP2 ADC developed with a novel linker to conjugate the payload, a belotecan-derivative topoisomerase I inhibitor with a drug-to-antibody-ratio (DAR) of 7.4... In this randomized phase Ⅲ trial, SKB264 was compared with physician's choice of chemotherapy (eribulin, vinorelbine, capecitabine, or gemcitabine) in pts with locally recurrent or metastatic TNBC who had received two or more prior therapies including at least one for metastatic setting... Sacituzumab tirumotecan monotherapy demonstrated statistically significant and clinically meaningful PFS and OS benefit over chemotherapy, with a manageable safety profile in pts with heavily pretreated advanced TNBC and limited treatment options."

Clinical • IO biomarker • Metastases • P3 data • Anemia • Breast Cancer • Hematological Disorders • Oncology • Solid Tumor • Triple Negative Breast Cancer • TACSTD2

Trastuzumab duocarmazine versus physician's choice therapy in pre-treated HER2-positive metastatic breast cancer: Final results of the phase III TULIP trial (ESMO 2023) - P3 | "Methods The TULIP trial randomly assigned patients with HER2-positive locally advanced or MBC with ≥2 previous HER2-targeting MBC regimens or pretreated with T-DM1, in a 2:1 ratio between T-Duo (1.2 mg/kg q3w) and PC. PC could be either trastuzumab combined with capecitabine or vinorelbine or eribulin or lapatinib plus capecitabine...The final OS results confirm a trend towards a numerically prolonged OS (statistically non-significant) in the T-Duo group compared with PC group. Safety was aligned with the primary analysis, with no new signals identified."

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