- |||||||||| Trodelvy (sacituzumab govitecan-hziy) / Everest Medicines, Gilead
[VIRTUAL] Impact of UGT1A1 status on the safety profile of sacituzumab govitecan in the phase 3 ASCENT study in patients with metastatic triple-negative breast cancer (OnDemand) - Oct 2, 2020 - Abstract #SABCS2020SABCS_749; P3 In the global, multicenter, open-label, phase 3 ASCENT study (NCT02574455), 529 patients with mTNBC refractory to or relapsing after at least 2 prior chemotherapies were randomized 1:1 to receive SG (10 mg/kg intravenously on days 1 and 8 every 21 days) or single-agent treatment of physician’s choice (capecitabine, eribulin, vinorelbine, or gemcitabine) until disease progression or unacceptable toxicity... These analyses will provide further insights into the safety profile of SG and appropriate AE management strategies for patients with previously treated mTNBC to allow optimal therapeutic exposure.
- |||||||||| Opdivo (nivolumab) / Ono Pharma, BMS, Cabometyx (cabozantinib tablet) / Takeda, Exelixis, Ipsen
[VIRTUAL] Comprehensive genomic analysis reveals molecular correlates of response to immune checkpoint inhibitors (ICI) in metastatic triple-negative breast cancer (mTNBC) (OnDemand) - Oct 2, 2020 - Abstract #SABCS2020SABCS_355; P1, P1b/2, We identified 31 women with mTNBC treated with ICI (pembrolizumab, n=6, NCT02447003; atezolizumab, n=4, NCT01375842; nivolumab + cabozantinib, n = 6, NCT03316586; pembrolizumab + eribulin, n=8, NCT02513472; atezolizumab + nab-paclitaxel, n=7, NCT01633970) who had tumor tissue or blood available for sequencing obtained before and after ICI... Clinical benefit to ICI in mTNBC was associated with upregulation of immune-related pathways, enrichment of non-tumoral PD-L1-positive cells in TME, and high TMB.
- |||||||||| Trodelvy (sacituzumab govitecan-hziy) / Everest Medicines, Gilead
[VIRTUAL] Biomarker evaluation in the phase 3 ASCENT study of sacituzumab govitecan versus chemotherapy in patients with metastatic triple-negative breast cancer (Channel 1) - Oct 2, 2020 - Abstract #SABCS2020SABCS_129; P3 In the global, multicenter, open-label, phase 3 ASCENT study (NCT02574455), 529 patients with mTNBC refractory to or relapsing after at least 2 prior chemotherapies were randomized 1:1 to receive SG (10 mg/kg intravenously on days 1 and 8 every 21 days) or single-agent treatment of physician’s choice (capecitabine, eribulin, vinorelbine, or gemcitabine) until disease progression or unacceptable toxicity... These analyses will provide further insights into the relationship of Trop-2 expression and the activity of SG in previously treated patients with mTNBC.
- |||||||||| Keytruda (pembrolizumab) / Merck (MSD)
[VIRTUAL] Pembrolizumab (pembro) vs chemotherapy (chemo) for previously treated metastatic triple:negative breast cancer (mTNBC): KEYNOTE-119 Asia-Pacific subpopulation (Channel 1) - Sep 24, 2020 - Abstract #ESMOAsia2020ESMO_Asia_130; P3 Pts were randomly assigned 1:1 to pembro 200 mg IV Q3W or physicians’ choice of single-agent chemo (capecitabine, eribulin, gemcitabine, or vinorelbine)...Funding: Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA. Clinical trial identification: NCT02555657; September 21, 2015.
- |||||||||| Jivadco (trastuzumab duocarmazine) / Byondis, Medac
Enrollment closed, Trial completion date, Trial primary completion date, Metastases: TULIP: SYD985 vs. Physician's Choice in Participants With HER2-positive Locally Advanced or Metastatic Breast Cancer (clinicaltrials.gov) - Sep 23, 2020 P3, N=436, Active, not recruiting, Clinical trial identification: NCT02555657; September 21, 2015. Recruiting --> Active, not recruiting | Trial completion date: May 2021 --> May 2022 | Trial primary completion date: Jul 2020 --> Jul 2021
- |||||||||| Halaven (eribulin mesylate) / Eisai
Journal, Adverse events: Eribulin and Confusion: A Previously Unknown Drug Side-Effect. (Pubmed Central) - Sep 12, 2020 Here we describe the case of a middle-aged woman treated with eribulin for advanced breast cancer who subsequently developed central nervous system drug-induced toxicity but improved promptly with steroid administration. Eribulin-induced encephalopathy is a diagnosis of exclusion and should be included in the differential diagnosis of patients treated with eribulin and presenting with altered mental status.Eribulin can cross the blood-brain barrier.Steroids and drug cessation should be the mainstay of treatment in cases of eribulin-induced encephalopathy.
- |||||||||| Halaven (eribulin mesylate) / Eisai
New trial, Metastases: Eribulin in mTNBC Patients (clinicaltrials.gov) - Sep 9, 2020 P, N=100, Active, not recruiting,
- |||||||||| Review, Journal: Contemporary management of metastatic soft tissue sarcoma. (Pubmed Central) - Sep 5, 2020
Histology-directed treatment is crucial for certain subtypes of STS which are highly sensitive to targeted therapy and relatively insensitive to chemotherapy. Despite the significant progress that has been made in metastatic STS in the past decade, overall prognosis is poor and there is a critical need for novel therapeutics.
- |||||||||| doxorubicin hydrochloride / Generic mfg.
[VIRTUAL] Soft tissue sarcomas: update systems therapies (Singapore) - Sep 3, 2020 - Abstract #DGHO2020DGHO_268; However, results of the phase III trial (ANNOUNCE) demonstrated that the study did not meet its primary endpoint in the full study population or in the leiomyosarcoma sub-population; there was no difference in overall survival between the study arms for either population. Other interesting candidates being tested in phase III study concepts such as selinexor as well as ongoing national and international trials of interest will be presented in this update.
- |||||||||| Trial completion date, Trial primary completion date, PD(L)-1 Biomarker, Surgery: Precise Local Injection of Anti-cancer Drugs Using Presage's CIVO Device in Soft Tissue Sarcoma (clinicaltrials.gov) - Sep 3, 2020
P1, N=24, Recruiting, Other interesting candidates being tested in phase III study concepts such as selinexor as well as ongoing national and international trials of interest will be presented in this update. Trial completion date: Jun 2020 --> Dec 2020 | Trial primary completion date: Jun 2020 --> Dec 2020
- |||||||||| Trodelvy (sacituzumab govitecan-hziy) / Immunomedics, Everest Medicines, vinorelbine tartrate / Generic mfg., irinotecan / Generic mfg.
[VIRTUAL] ASCENT: A randomized phase III study of sacituzumab govitecan (SG) vs treatment of physician’s choice (TPC) in patients (pts) with previously treated metastatic triple-negative breast cancer (mTNBC) (Channel 1) - Aug 27, 2020 - Abstract #ESMO2020ESMO_3395; P3 SG (TRODELVY™) is a first-in-class antibody-drug conjugate (ADC) composed of an anti–Trop-2 antibody coupled to the active metabolite of irinotecan, SN-38, via a unique hydrolyzable linker that allows for SN-38 release intracellularly and in the tumor microenvironment (bystander effect)...Methods In the ASCENT study (NCT02574455), pts with mTNBC who had relapsed/refractory disease after ≥2 prior chemotherapies in the advanced/metastatic setting (prior taxane required) were randomized 1:1 to receive SG (10 mg/kg IV on d 1, 8 every 21 d) or single-agent TPC (capecitabine, eribulin, vinorelbine, or gemcitabine) until disease progression/unacceptable toxicity...Funding: Immunomedics Inc. Clinical trial identification: NCT02574455.
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