Alocrest (vinorelbine liposomal) / Assertio - LARVOL DELTA

Phase II Study of Second- Line Pembrolizumab Plus GVD for Relapsed or Refractory Hodgkin Lymphoma (clinicaltrials.gov) - P2; N=64; Recruiting; Sponsor: Memorial Sloan Kettering Cancer Center; N=39 ➔ 64

Clinical • Enrollment change • Hematological Malignancies • Hodgkin Lymphoma • Lymphoma • Oncology

Final results of a phase II study of oral vinorelbine (NVBo) monotherapy in patients (pts) with advanced EGFR-positive non-small-cell lung cancer (NSCLC) after failure of EGFR-TKI in first line (NAVoTRIAL 2) (ESMO 2016) - P2; "NVBo as single-agent CT is a well-tolerated option in advanced EGFR+ NSCLC pts beyond failure of EGFR-TKI in first line. Its favourable tolerability profile allows a prolonged disease control in non-progressing pts."

Clinical • Biosimilar • Non Small Cell Lung Cancer • Oncology

Chidamide Combined With VDDT Regimen in the Relapse and Refractory Diffuse Large B Cell Lymphoma (clinicaltrials.gov) - P2; N=20; Recruiting; Sponsor: Henan Cancer Hospital; Trial completion date: May 2020 ➔ May 2021; Trial primary completion date: May 2019 ➔ May 2020

Clinical • Trial completion date • Trial primary completion date • Diffuse Large B Cell Lymphoma • Hematological Disorders • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

Phase II Study of Second- Line Pembrolizumab Plus GVD for Relapsed or Refractory Hodgkin Lymphoma (clinicaltrials.gov) - P2; N=39; Recruiting; Sponsor: Memorial Sloan Kettering Cancer Center; Trial completion date: Aug 2020 ➔ Aug 2021; Trial primary completion date: Aug 2020 ➔ Aug 2021

Clinical • Trial completion date • Trial primary completion date • Gastrointestinal Cancer • Hematological Disorders • Hematological Malignancies • Hodgkin Lymphoma • Lymphoma • Oncology • Solid Tumor

Long-Term Follow-up Confirms Durability of Single-Agent Brentuximab Vedotin As Pre-Transplant Salvage for Classical Hodgkin Lymphoma (ASH 2019) - "We conducted a phase II study evaluating PET-adapted SLT with single-agent brentuximab vedotin (BV) followed by augICE (augmented ifosfamide, carboplatin, etoposide) for BV-naïve patients with RR cHL (Lancet Oncology 2015)...That individual achieved PET-normalization following additional salvage chemotherapy (gemcitabine/vinorelbine/liposomal doxorubicin) and proceeded to ASCT... For pts with RR cHL, long-term remission can be achieved following lower-intensity SLT with single-agent BV followed by ASCT, provided PET-normalization is achieved after single-agent BV. bMTV identifies which pts within this favorable group are likely to develop disease progression and therefore treatment strategies using bMTV to direct intensity of therapy should be explored."

Dose-escalation Study of Intravenous Liposomal Vinorelbine Tartrate Injection in Patients With Advanced Malignancy (clinicaltrials.gov) - P1/2; N=51; Recruiting; Sponsor: Taiwan Liposome Company; Trial completion date: Sep 2019 ➔ Dec 2020; Trial primary completion date: Jun 2019 ➔ Dec 2020

Clinical • Trial completion date • Trial primary completion date

In vivo efficacy and enhanced tumour accumulation of liposomal vinorelbine (TLC178) in human sarcoma xenograft mice model (ESMO 2019) - " In efficacy studies (Study #PD17060, #PD17069 and #PD17008), TLC178 not only showed better inhibitory effect than that of VNB alone and VNB+CTX treatments in the SJCRH30 RMS xenograft model, but also remarkably suppressed HT1080 human fibrosarcoma compared with doxorubicin, an approved drug for treatment of sarcomas. TLC178 demonstrated improved in vivo systemic VNB PK profile and tumor distribution, which resulted in superior anti-cancer efficacy compared to traditional VNB treatment. Therefore, TLC178 may have potential as a single or combination treatment for sarcomas with decreased dosage and/or frequency, reduced toxicity, and enhanced efficacy. Legal entity responsible for the study: Taiwan Liposome Company, Ltd."

Preclinical