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- || sacituzumab govitecan (IMMU-132) / Immunomedics
My colleague @DrScottTagawa presenting IMMU-132 data in #bladdercancer #ESMO19 @cornellGUcancer (Twitter) - Sep 29, 2019
- ||||| infigratinib (BGJ398) / BridgeBio, Pfizer, sacituzumab govitecan (IMMU-132) / Immunomedics, enfortumab vedotin (ASG-22ME) / Seattle Genetics, Astellas
Outstanding overview of rapidly changing landscape of metastatic urothelial carcinoma by @PGrivasMDPhD @fredhutch at #ESMO19 @myESMO current Treatment algorithm, emerging Rx including infigratinib, enfortumab, sacituzumab and more (Twitter) - Sep 29, 2019
- ||||| infigratinib (BGJ398) / BridgeBio, Pfizer, sacituzumab govitecan (IMMU-132) / Immunomedics, enfortumab vedotin (ASG-22ME) / Seattle Genetics, Astellas
Outstanding overview of rapidly changing landscape of metastatic urothelial carcinoma by @PGrivasMDPhD @fredhutch at #ESMO19 @myESMO current Treatment algorithm, emerging Rx including infigratinib, enfortumab, sacituzumab and more (Twitter) - Sep 29, 2019
- |||| sacituzumab govitecan (IMMU-132) / Immunomedics
Clinical: Interesting data in other cancers with sacituzumab which has shown very promising activity in #TNBC #bcsm hopefully results of the completed study ASCENT will lead to this becoming available for patients with TNBC (Twitter) - Sep 28, 2019
- ||||| sacituzumab govitecan (IMMU-132) / Immunomedics
Phenomenal effort by @DrScottTagawa & a great team (nice to work with) with data presented #ESMO19 showing very promising activity of IMMU132 in heavily pretreated mUC @OncoAlert @BladderCancerUS @SeattleCCA @urotoday @fredhutch @IBCN1997 @uwurology @CarolynBestAUA @ASCO https://t.co/oR4suFEmIR (Twitter) - Sep 28, 2019
- ||| sacituzumab govitecan (IMMU-132) / Immunomedics, enfortumab vedotin (ASG-22ME) / Seattle Genetics, Astellas
Very encouraging results presented by @DrScottTagawa #ESMO19 Hopefully sacituzumab and enfortumab will replace more toxic 1st line platinum chemo in advanced UC soon. Great team effort with @PGrivasMDPhD @ArjunBalarMD on this trial, also open at @huntsmancancer (Twitter) - Sep 28, 2019
- ||||| sacituzumab govitecan (IMMU-132) / Immunomedics, enfortumab vedotin (ASG-22ME) / Seattle Genetics, Astellas
Clinical: TROPHY-U-01 trial with sacituzumab govintecan for heavily pre-treated mUC, including some patients post IOs and post enfortumab vedotin, shows good ORR and maneageble toxicity #ESMO19 (Twitter) - Sep 28, 2019
- sacituzumab govitecan (IMMU-132) / Immunomedics, vinorelbine tartrate / Generic mfg., irinotecan / Generic mfg.
Tropics-02: phase 3 study of Sacituzumab Govitecan (IMMU-132) in relapsed/refractory hormonal receptor-positive (HR+) human epidermal growth factor receptor 2 negative (HER2-) metastatic breast cancer (MBC) (Hall 1) - Sep 25, 2019 - Abstract #SABCS2019SABCS_1780;
P3
Sacituzumab govitecan (SG) is a novel antibody-drug conjugate comprising an anti-Trop-2 monoclonal antibody conjugated to SN-38 (active metabolite of irinotecan) in a high drug-to-antibody ratio of 7.6...Pts are randomized 1:1 to receive SG (10 mg/kg intravenously, days 1 and 8 every 21 days) or treatment of physician’s choice (TPC, determined pre-randomization: eribulin, capecitabine, gemcitabine, vinorelbine)...Biomarker samples are taken at baseline, pre-dose at cycle 2, and at disease progression/end of treatment. Approximately 400 pts will be randomized across multiple countries.
- | Trodelvy (sacituzumab govitecan-hziy) / Gilead
Enrollment closed, Metastases: ASCENT: Trial of Sacituzumab Govitecan in Participants With Refractory/Relapsed Metastatic Triple-Negative Breast Cancer (TNBC) (clinicaltrials.gov) - Sep 23, 2019
P3, N=529, Active, not recruiting, Sponsor: Immunomedics, Inc.
Approximately 400 pts will be randomized across multiple countries. Recruiting --> Active, not recruiting
- | Trodelvy (sacituzumab govitecan-hziy) / Gilead
Enrollment open, Metastases: TROPICS-03: Study of Sacituzumab Govitecan in Participants With Metastatic Solid Tumors (clinicaltrials.gov) - Sep 22, 2019
P2, N=600, Recruiting, Sponsor: Immunomedics, Inc.
Recruiting --> Active, not recruiting Not yet recruiting --> Recruiting
- sacituzumab govitecan (IMMU-132) / Immunomedics
Initial results from TROPHY-U-01: A phase II open-label study of sacituzumab govitecan in patients (Pts) with metastatic urothelial cancer (mUC) after failure of platinum-based regimens (PLT) or immunotherapy (Barcelona Auditorium (Hall 2)) - Sep 11, 2019 - Abstract #ESMO2019ESMO_3551;
P2
Findings confirm prior phase I/II study results of SG as well-tolerated with significant antitumor activity in mUC pts after both prior PLT and CPI. In this population that continues to have a high unmet medical need despite recent progress, the ORR of 29% compares favorably with single-agent chemotherapy (ORR of 9%–14%).
- sacituzumab govitecan (IMMU-132) / Immunomedics
CNS penetration and preliminary efficacy of sacutizumab govitecan in breast brain metastasis and glioblastoma: A surgical study (Poster Area (Hall 4)) - Sep 11, 2019 - Abstract #ESMO2019ESMO_1567;
Background: Sacituzumab govitecan (SG) is an antibody drug conjugate (ADC) that targets Trop-2 for the selective delivery of SN-38 to tumors...Legal entity responsible for the study: University of Texas Health San Antonio. Funding: Mays Cancer Center, Kolitz Endowment.
- Trodelvy (sacituzumab govitecan-hziy) / Immunomedics, Everest Medicines, irinotecan / Generic mfg.
SACITUZUMAB GOVITECAN IN UTERINE AND OVARIAN CARCINOSARCOMAS (E-Poster Area (Americas)) - Sep 10, 2019 - Abstract #IGCS2019IGCS_844;
SG demonstrated remarkable antitumor activity against biologically aggressive CS overexpressing Trop-2 and due to its hydrolizable linker may cause a significant bystander killing effect in CS with heterogenous TROP-2 expression. Clinical trials are warranted.
- Trodelvy (sacituzumab govitecan-hziy) / Immunomedics, Everest Medicines, irinotecan / Generic mfg.
IN VITRO AND IN VIVO ACTIVITY OF SACITUZUMAB GOVITECAN, IN OVARIAN CANCER (Asia A) - Sep 10, 2019 - Abstract #IGCS2019IGCS_662;
SG has shown remarkable preclinical activity against biologically aggressive EOC and it is endowed with significant bystander effect against tumors with heterogenous TROP-2 expression. Clinical trials are warranted.
- | Trodelvy (sacituzumab govitecan-hziy) / Gilead, Talzenna (talazoparib) / Pfizer
Trial completion date, Combination therapy, Metastases: Study to Evaluate Sacituzumab Govitecan in Combination With Talazoparib in Patients With Metastatic Breast Cancer. (clinicaltrials.gov) - Aug 28, 2019
P1b/2, N=65, Not yet recruiting, Sponsor: Massachusetts General Hospital
Clinical trials are warranted. Trial completion date: Aug 2026 --> Aug 2024
- | Herceptin (trastuzumab) / Roche, Ultomiris IV (ravulizumab IV) / Alexion Pharma
Journal: Antibodies to watch in 2019. (Pubmed Central) - Aug 1, 2019
In addition, our data show that 3 product candidates (leronlimab, brolucizumab, polatuzumab vedotin) may enter regulatory review by the end of 2018, and at least 12 (eptinezumab, teprotumumab, crizanlizumab, satralizumab, tanezumab, isatuximab, spartalizumab, MOR208, oportuzumab monatox, TSR-042, enfortumab vedotin, ublituximab) may enter regulatory review in 2019...Of these, 7 (tremelimumab, spartalizumab, BCD-100, omburtamab, mirvetuximab soravtansine, trastuzumab duocarmazine, and depatuxizumab mafodotin) are being evaluated in clinical studies with primary completion dates in late 2018 and in 2019, and are thus 'antibodies to watch'. We look forward to documenting progress made with these and other 'antibodies to watch' in the next installment of this article series.
- | Trodelvy (sacituzumab govitecan-hziy) / Gilead
Enrollment open: Neuro/Sacituzumab Govitecan/Breast Brain Metastasis/Glioblastoma/Ph 0 (clinicaltrials.gov) - Jul 31, 2019
P1, N=20, Recruiting, Sponsor: The University of Texas Health Science Center at San Antonio
We look forward to documenting progress made with these and other 'antibodies to watch' in the next installment of this article series. Not yet recruiting --> Recruiting
- | Bavencio (avelumab) / EMD Serono, Trodelvy (sacituzumab govitecan-hziy) / Gilead, Mektovi (binimetinib) / Ono Pharma, Pierre Fabre, Pfizer
Enrollment open, Tumor mutational burden, Metastases: InCITe: Avelumab With Binimetinib, Sacituzumab Govitecan, or Liposomal Doxorubicin in Treating Stage IV or Unresectable, Recurrent Triple Negative Breast Cancer (clinicaltrials.gov) - Jul 28, 2019
P2, N=150, Recruiting, Sponsor: Hope Rugo, MD
Not yet recruiting --> Recruiting Not yet recruiting --> Recruiting
- | Enrollment change, Metastases: Morpheus Lung: A Study Of Multiple Immunotherapy-Based Treatment Combinations In Participants With Metastatic Non-Small Cell Lung Cancer (Morpheus- Non-Small Cell Lung Cancer) (clinicaltrials.gov) - Jul 11, 2019
P1/2, N=250, Recruiting, Sponsor: Hoffmann-La Roche
Not yet recruiting --> Recruiting N=410 --> 250
- | Review, Journal: Advances in antibody therapeutics targeting small-cell lung cancer. (Pubmed Central) - Jul 4, 2019
Bec2/BCG as an adjuvant vaccination in patients with limited-disease SCLC could not improve the survival, PFS, or quality of life. Thus, clinical studies are essential to confirm the anti-tumor efficacy of trastuzumab in SCLC.
- || Trodelvy (sacituzumab govitecan-hziy) / Gilead
New P1 trial: Neuro/Sacituzumab Govitecan/Breast Brain Metastasis/Glioblastoma/Ph 0 (clinicaltrials.gov) - Jun 23, 2019
P1, N=20, Not yet recruiting, Sponsor: Andrew Brenner
- | sacituzumab govitecan (IMMU-132) / Immunomedics
Journal: Sacituzumab Govitecan-hziy in Triple-Negative Breast Cancer. (Pubmed Central) - Jun 22, 2019
Thus, clinical studies are essential to confirm the anti-tumor efficacy of trastuzumab in SCLC. No abstract available
- | Trodelvy (sacituzumab govitecan-hziy) / Everest Medicines, Gilead
Journal: Sacituzumab Govitecan-hziy in Triple-Negative Breast Cancer. Reply. (Pubmed Central) - Jun 22, 2019
No abstract available No abstract available
- |||| sacituzumab govitecan (IMMU-132) / Immunomedics, enfortumab vedotin (ASG-22ME) / Seattle Genetics, Astellas
Good hard hitting questions from audience. If you had sacituzumab and enfortumab available tomorrow, which would you use? @lalaniMD @DrChoueiri @DrRanaMcKay @drcmassard @shaan_dudani @MattGalsky @ASCO @neerajaiims @PGrivasMDPhD @TDorffOnc @BladderCancerUS @PauloBergerot #ASCO19 (Twitter) - Jun 3, 2019
- |||| Bavencio (avelumab) / EMD Serono, Trodelvy (sacituzumab govitecan-hziy) / Gilead, Mektovi (binimetinib) / Ono Pharma, Pierre Fabre, Pfizer
New P2 trial, Tumor mutational burden, Metastases: InCITe: Avelumab With Binimetinib, Sacituzumab Govitecan, or Liposomal Doxorubicin in Treating Stage IV or Unresectable, Recurrent Triple Negative Breast Cancer (clinicaltrials.gov) - Jun 2, 2019
P2, N=150, Not yet recruiting, Sponsor: Hope Rugo, MD
- ||||| Trodelvy (sacituzumab govitecan-hziy) / Gilead
New P2 trial, Metastases: TROPICS-03: Study of Sacituzumab Govitecan in Participants With Metastatic Solid Tumors (clinicaltrials.gov) - May 28, 2019
P2, N=600, Not yet recruiting, Sponsor: Immunomedics, Inc.
- |||| sacituzumab govitecan (IMMU-132) / Immunomedics, Keytruda (pembrolizumab) / Merck (MSD)
Clinical: Rremarkable work by @MattGalsky (PFS endpoint met with pembro maintenance after 1L Tx) Rosenberg (Alliance GC/bev vs GC ph 3 trial) & their teams! Also EV hits ORR > 40%! @DrScottTagawa will discuss IMMU-132! SWOG1314 trial will be reported 1st time & SAUL trial updated! #ASCO19 (Twitter) - May 25, 2019
- ||| sacituzumab govitecan (IMMU-132) / Immunomedics
Side Q - Does Sacituzumab or any of the newer agentshave good CNS penetration? Relapsed TNBC with leptomeningeal disease starting IT Mtx (Twitter) - May 8, 2019
- |||| Enrollment open, PD(L)-1 Biomarker: MORPHEUS mUC: Study Evaluating the Efficacy and Safety of Multiple Immunotherapy-Based Treatments and Combinations in Patients With Urothelial Carcinoma (MORPHEUS-UC) (clinicaltrials.gov) - May 6, 2019
P1/2, N=305, Recruiting, Sponsor: Hoffmann-La Roche
No abstract available Not yet recruiting --> Recruiting
- |||||| Trodelvy (sacituzumab govitecan-hziy) / Gilead
Enrollment open, Metastases: TROPiCS-02: Study of Sacituzumab Govitecan-hziy Versus Treatment of Physician's Choice in Participants With HR+/HER2- Metastatic Breast Cancer (clinicaltrials.gov) - Apr 29, 2019
P3, N=400, Recruiting, Sponsor: Immunomedics, Inc.
Not yet recruiting --> Recruiting Not yet recruiting --> Recruiting
- ||| labetuzumab govitecan (IMMU-130) / Gilead
Trial completion, Trial completion date, Metastases: IMMU-130-02: Study of Labetuzumab Govitecan in Participants With Metastatic Colorectal Cancer (clinicaltrials.gov) - Apr 20, 2019
P1/2, N=71, Completed, Sponsor: Immunomedics, Inc.
Not yet recruiting --> Recruiting Active, not recruiting --> Completed | Trial completion date: Mar 2019 --> Oct 2018
- | sacituzumab govitecan (IMMU-132) / Immunomedics
Review, Journal: Antibody-drug conjugates of 7-ethyl-10-hydroxycamptothecin: Sacituzumab govitecan and labetuzumab govitecan. (Pubmed Central) - Apr 19, 2019
Here, the SN-38 families together with sacituzumab govitecan and labetuzumab govitecan are reviewed, whose features of metabolic pathway and toxicity in vivo are well-known. In sum, these methodology and technology would be convenient and flexible to be applied for developing the novel class of cytotoxins in ADCs industry.
- | sacituzumab govitecan (IMMU-132) / Immunomedics, glembatumumab vedotin (CDX-011) / Celldex, ladiratuzumab vedotin (SGN-LIV1A) / Seattle Genetics
Journal, BRCA Biomarker: Antibody-drug conjugates in triple negative breast cancer. (Pubmed Central) - Apr 3, 2019
One emerging treatment modality includes antibody-drug conjugates which are highly selective monoclonal antibodies conjugated to cytotoxic agents, designed to deliver cytotoxic drugs to antigen-expressing tumor cells. This review will highlight three antibody-drug conjugates currently being evaluated in TNBC (CDX-011, SGN-LIV1a, IMMU-132), including one that has been given Breakthrough Therapy designation from the US FDA.
- |||||||||| Trodelvy (sacituzumab govitecan-hziy) / Gilead
New P3 trial, Metastases: TROPiCS-02: Study of Sacituzumab Govitecan-hziy Versus Treatment of Physician's Choice in Participants With HR+/HER2- Metastatic Breast Cancer (clinicaltrials.gov) - Apr 3, 2019
P3, N=400, Not yet recruiting, Sponsor: Immunomedics, Inc.
- || sacituzumab govitecan (IMMU-132) / Immunomedics
Dr. Bardia on Sacituzumab Govitecan in TNBC @harvardmed #bcsm https://t.co/prbBohXR5W (Twitter) - Mar 30, 2019
- ||||| New P1/2 trial, PD(L)-1 Biomarker: MORPHEUS mUC: Study Evaluating the Efficacy and Safety of Multiple Immunotherapy-Based Treatments and Combinations in Patients With Urothelial Carcinoma (MORPHEUS-UC) (clinicaltrials.gov) - Mar 10, 2019
P1/2, N=305, Not yet recruiting, Sponsor: Hoffmann-La Roche
- | Trodelvy (sacituzumab govitecan-hziy) / Everest Medicines, Gilead
Clinical Trial,Phase I, Clinical Trial,Phase II, Journal: Sacituzumab Govitecan-hziy in Refractory Metastatic Triple-Negative Breast Cancer. (Pubmed Central) - Mar 2, 2019
P1/2
Myelotoxic effects were the main adverse reactions. (Funded by Immunomedics; IMMU-132-01 ClinicalTrials.gov number, NCT01631552.).
- ||| Enrollment change, Metastases: Morpheus Lung: A Study Of Multiple Immunotherapy-Based Treatment Combinations In Participants With Metastatic Non-Small Cell Lung Cancer (Morpheus- Non-Small Cell Lung Cancer) (clinicaltrials.gov) - Mar 1, 2019
P1/2, N=410, Recruiting, Sponsor: Hoffmann-La Roche
(Funded by Immunomedics; IMMU-132-01 ClinicalTrials.gov number, NCT01631552.). N=292 --> 410
- ||||| Trodelvy (sacituzumab govitecan-hziy) / Gilead
Enrollment change, Metastases: ASCENT: Trial of Sacituzumab Govitecan in Participants With Refractory/Relapsed Metastatic Triple-Negative Breast Cancer (TNBC) (clinicaltrials.gov) - Dec 11, 2018
P3, N=488, Recruiting, Sponsor: Immunomedics, Inc.
N=292 --> 410 N=328 --> 488
- | Trodelvy (sacituzumab govitecan-hziy) / Gilead
Enrollment change: IMMU-132-01: Study of Sacituzumab Govitecan-hziy (IMMU-132) in Adults With Epithelial Cancer (clinicaltrials.gov) - Nov 29, 2018
P1/2, N=500, Active, not recruiting, Sponsor: Immunomedics, Inc.
N=328 --> 488 N=250 --> 500
- | labetuzumab govitecan (IMMU-130) / Gilead
Enrollment closed, Enrollment change, Trial completion date, Trial primary completion date, Metastases: IMMU-130-02: Study of Labetuzumab Govitecan in Participants With Metastatic Colorectal Cancer (clinicaltrials.gov) - Nov 15, 2018
P1/2, N=71, Active, not recruiting, Sponsor: Immunomedics, Inc.
N=250 --> 500 Recruiting --> Active, not recruiting | N=104 --> 71 | Trial completion date: Dec 2016 --> Mar 2019 | Trial primary completion date: Dec 2016 --> Oct 2018
- | Trodelvy (sacituzumab govitecan-hziy) / Gilead
Trial completion date, Trial primary completion date: IMMU-132-01: Study of Sacituzumab Govitecan-hziy (IMMU-132) in Adults With Epithelial Cancer (clinicaltrials.gov) - Nov 13, 2018
P1/2, N=250, Active, not recruiting, Sponsor: Immunomedics, Inc.
Recruiting --> Active, not recruiting | N=104 --> 71 | Trial completion date: Dec 2016 --> Mar 2019 | Trial primary completion date: Dec 2016 --> Oct 2018 Trial completion date: Jun 2018 --> Sep 2019 | Trial primary completion date: Jun 2018 --> Jun 2019
- | Trodelvy (sacituzumab govitecan-hziy) / Gilead
Enrollment open, Metastases: TROPHY-U-01: Study of Sacituzumab Govitecan in Participants With Urothelial Cancer That Cannot Be Removed or Has Spread (clinicaltrials.gov) - Nov 9, 2018
P2, N=140, Recruiting, Sponsor: Immunomedics, Inc.
Trial completion date: Jun 2018 --> Sep 2019 | Trial primary completion date: Jun 2018 --> Jun 2019 Not yet recruiting --> Recruiting
- | Trodelvy (sacituzumab govitecan-hziy) / Gilead
Enrollment open, Metastases: NCI-2018-02551: Sacituzumab Govitecan in Patients With Metastatic Castration-Resistant Prostate Cancer Progressing on Second Generation AR-Directed Therapy (clinicaltrials.gov) - Nov 8, 2018
P2, N=55, Recruiting, Sponsor: University of Wisconsin, Madison
Not yet recruiting --> Recruiting Not yet recruiting --> Recruiting
- | Trodelvy (sacituzumab govitecan-hziy) / Gilead
New P2 trial, Metastases: NCI-2018-02551: Sacituzumab Govitecan in Patients With Metastatic Castration-Resistant Prostate Cancer Progressing on Second Generation AR-Directed Therapy (clinicaltrials.gov) - Oct 31, 2018
P2, N=55, Not yet recruiting, Sponsor: University of Wisconsin, Madison
- | Trodelvy (sacituzumab govitecan-hziy) / Everest Medicines, Gilead, Padcev (enfortumab vedotin) / Seagen, Astellas, Vicineum (oportuzumab monatox) / Sesen Bio
Review, Journal: Antibody-Drug Conjugates in Bladder Cancer. (Pubmed Central) - Aug 18, 2018
The most promising ones include human epidermal growth factor receptor 2 (HER2) and members of the fibroblast growth factor receptor axis (FGF/FGFR). Positive preclinical and early clinical results are reported in many cases, thus the next step involves further improving efficacy and reducing toxicity as well as testing combination strategies with approved agents.
- | Imjudo (tremelimumab) / AstraZeneca, Pfizer, Imfinzi (durvalumab) / AstraZeneca
New P2 trial, Tumor-specific neoantigens, PD(L)-1 Biomarker, Metastases: NCI-2018-01581: Testing the Addition of an Individualized Vaccine to Durvalumab and Tremelimumab and Chemotherapy in Patients With Metastatic Triple Negative Breast Cancer (clinicaltrials.gov) - Jul 31, 2018
P2, N=70, Not yet recruiting, Sponsor: National Cancer Institute (NCI)
- | Trodelvy (sacituzumab govitecan-hziy) / Everest Medicines, Gilead
Journal: Therapy of Small-cell Lung Cancer (SCLC) With a Topoisomerase-I-inhibiting Antibody-Drug Conjugate (ADC) Targeting Trop-2, Sacituzumab Govitecan. (Pubmed Central) - Jul 20, 2018
Sacituzumab govitecan appears to have a safe and effective therapeutic profile in heavily-pretreated, mSCLC patients, including those who are chemosensitive or chemoresistant to frontline chemotherapy. Additional studies as a monotherapy or combination therapy are warranted.
- |||| Trodelvy (sacituzumab govitecan-hziy) / Gilead
New P2 trial, Metastases: TROPHY-U-01: Study of Sacituzumab Govitecan in Participants With Urothelial Cancer That Cannot Be Removed or Has Spread (clinicaltrials.gov) - Jul 15, 2018
P2, N=140, Not yet recruiting, Sponsor: Immunomedics, Inc.