Sacituzumab govitecan (SG) is an antibody-drug conjugate composed of an anti-Trop-2-directed antibody conjugated with the topoisomerase I inhibitory drug, SN-38, via a proprietary hydrolysable linker. SG has received United States Food and Drug Administration (FDA) approval to treat metastatic triple-negative breast cancer (TNBC), unresectable locally advanced or metastatic hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative breast cancer, and accelerated approval for metastatic urothelial cancer. We investigated the utility of combining SG with platinum-based chemotherapeutics in TNBC, urinary bladder carcinoma (UBC), and small-cell lung carcinoma (SCLC). SG plus carboplatin or cisplatin produced additive growth-inhibitory effects in vitro that trended towards synergy. Immunoblot analysis of cell lysates suggests perturbation of the cell-cycle and a shift towards pro-apoptotic signaling evidenced by an increased Bax to Bcl-2 ratio and down-regulation of two anti-apoptotic proteins, Mcl-1 and survivin. Significant antitumor effects were observed with SG plus carboplatin in mice bearing TNBC or SCLC tumors compared to all controls (P < 0.0062 and P < 0.0017, respectively) and with SG plus cisplatin in UBC and SCLC tumor-bearing animals (P < 0.0362 and P < 0.0001, respectively). These combinations were well tolerated by the animals. Combining SG with platinum-based chemotherapeutics demonstrates the benefit in these indications and warrants further clinical investigation.

Evaluation of the procedure used to quantitate the constitutive products derived from irinotecan or IMMU-132.

PDF file - 60K, Serum cholesterol levels from mice treated with DEX and L-DEX

Relative mRNA levels of ABCG2 determined by RT-qPCR

Supplementary Table S1. Extraction efficiency for isolation of SN-38 in buffer with or without human serum albumin (HSA) or from the ADC with or without acid hydrolysis followed by extraction; Supplementary Figure S1. Schematic depiction of the conjugation of CL2A-SN-38 to mildly reduced IgG yielding site-specifically coupled SN-38 to 8 well-defined sites; Supplementary Figure S2. CL2A-SN38 amide capped with N-acetylcysteine; Supplementary Figure S3. SDS-Page gels comparing profiles for labetuzumab (unconjugated hMN-14 IgG) and labetuzumab govitecan (CL2A-SN-38 conjugated hMN-14 IgG; IMMU-130); Supplementary Figure S4. In vitro cell binding assay performed on LS174T cells, evaluating the binding of unconjugated hMN-14 IgG and SN-38-conjugated hMN-14 IgG (IMMU-130); Supplementary Figure S5. Stability of IMMU-130 in serum from different sources; Supplementary Figure S6. Evaluation of lactone ring stability of the CL2A-linked SN-38 compared to SN-38 at pH 7.4.

Supplementary Figures S1-S2; Supplementary Materials and Methods; Supplementary Tables S1-S2.

Supplementary Fig. S1 from Role of placenta growth factor in malignancy and evidence that an antagonistic PlGF/Flt-1 peptide inhibits the growth and metastasis of human breast cancer xenografts

Supplementary sections, including additional Materials and Methods, as well as Results and Tables. Table S1. SN-38 and SN-38G standard curves using triplicate dilutions of each concentration with single HPLC run. Table S2. SN-38 extraction efficiency. Table S3. Area under the curve (AUC) analysis of various products in the serum of nude mice given irinotecan or IMMU-132. Table S4. In vitro glucuronidation assay. Table S5. Analysis of products in the large intestine of animals given irinotecan or IMMU-132 (Study 2). Values represent the mean {plus minus} SD (N = 3) and are expressed in µg.

Supplementary materials Material and Methods Supplemental Figure 1: Quantitative assessment of mRNA expression of Mcl-1, RelA and Stat3 in anaplastic thyroid carcinoma (ATC) cell lines and resected ATC's using qRT-PCR. Supplemental Figure 2: Expressions of NFï«B-p65 and Stat3pY in ATC. Supplemental Figure 3: Assessment of medical and staining parameters relationship to the overall survival (OS) in the ATC cohort. Supplemental Figure 4: Meta analysis of previously published expression profiles on ATC's. Supplemental Figure 5: Model schematic displaying drug synergy from the drug combination of sorafenib/quinacrine through the targeting of expression of anti-apoptotic Mcl-1. Supplemental Figure 6: In vivo optical near-infrared (NIR) imaging of orthotopic xenografts of human ATC cells. Supplemental Figure 7: Serum chemistry indicates lack of apparent toxicity by the S/Q combination. Supplemental Figure 8: Hematology indicates lack of apparent toxicity by the S/Q combination. Supplemental Figure 9: Reduced surface occupancy of CD34-positive small vessel endothelium and VEGF-expression in 8505C tumor xenografts treated with the combination of sorafenib and quinacrine.

Sacituzumab govitecan (SG) is an anti-Trop-2 antibody-drug conjugate with an SN-38 payload. 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). This ASCENT safety analysis includes the impact of age and UGT1A1 polymorphisms, which hinder SN-38 detoxification. SG demonstrated a manageable safety profile in patients with mTNBC, including those ≥65 years; neutropenia/diarrhea are key adverse events (AE). 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.

Abstract Background: Trophoblast cell-surface antigen-2 (Trop-2) is highly expressed in many epithelial tumors, including triple-negative breast cancer (TNBC). Sacituzumab govitecan (SG) is an antibody-drug conjugate composed of an anti-Trop-2 antibody coupled to SN-38, an active metabolite of irinotecan, via a unique hydrolyzable linker that allows for SN-38 release intracellularly and in the tumor microenvironment (bystander effect). Preclinical studies have shown a great range of efficacy with SG in mice bearing tumors with low, moderate, and high Trop-2 expression levels. We report subgroup analyses by Trop-2 expression from ASCENT, a randomized, phase 3 confirmatory study of SG versus standard-of-care chemotherapy in patients with metastatic TNBC (mTNBC). Methods: 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. The primary endpoint was progression-free survival (PFS) measured by central independent review per RECIST v1.1. Secondary endpoints included objective response rate (ORR) per RECIST v1.1, duration of response, overall survival (OS), and safety. Exploratory endpoints included biomarker assessments, including Trop-2 and BRCA1/2. Trop-2 expression was assessed using a validated immunohistochemistry assay. Results: Subgroup analyses by biomarker expression including Trop-2 and BRCA1/2 were performed, and outcomes by PFS, OS, ORR, and safety results will be reported. Conclusions: These analyses will provide further insights into the relationship of Trop-2 expression and the activity of SG in previously treated patients with mTNBC. Citation Format: Sara A. Hurvitz, Sara M. Tolaney, Kevin Punie, Delphine Loirat, Mafalda Oliveira, Kevin Kalinsky, Amelia Zelnak, Philippe Aftimos, Florence Dalenc, Sagar Sardesai, Erika Hamiltion, Priyanka Sharma, Sabela Recalde, Eva Ciruelos Gil, Tiffany Traina, Joyce O'Shaughnessy, Javier Cortés, Michaela Tsai, Linda Vahdat, Véronique Diéras, Lisa Carey, Hope S. Rugo, David M. Goldenberg, Quan Hong, Martin Olivo, Loretta M. Itri, Aditya Bardia. Biomarker evaluation in the phase 3 ASCENT study of sacituzumab govitecan versus chemotherapy in patients with metastatic triple-negative breast cancer [abstract]. In: Proceedings of the 2020 San Antonio Breast Cancer Virtual Symposium; 2020 Dec 8-11; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2021;81(4 Suppl):Abstract nr GS3-06.

Pretargeting parameters for the use of anti-carcinoembryonic antigen (CEA) bispecific monoclonal antibody TF2 and the 68Ga-labeled IMP288 peptide for immuno-PET have been optimized in a first-in-humans study performed on medullary thyroid carcinoma (MTC) patients (the iPET-MTC study). The aim of this post hoc analysis was to determine the sensitivity of immuno-PET in relapsing MTC patients, in comparison with conventional imaging and 18F-l-dihydroxyphenylalanine (18F-DOPA) PET/CT. Methods: Twenty-five studies were analyzed in 22 patients. All patients underwent immuno-PET 1 and 2 h after 68Ga-IMP288 injection pretargeted by TF2, in addition to neck, thoracic, abdominal, and pelvic CT; bone and liver MRI; and 18F-DOPA PET/CT. The gold standard was histology or confirmation by one other imaging method or by imaging follow-up. Results: In total, 190 lesions were confirmed by the gold standard: 89 in lymph nodes, 14 in lungs, 46 in liver, 37 in bone, and 4 in other sites (subcutaneous tissue, heart, brain, and pancreas). The number of abnormal foci detected by immuno-PET was 210. Among these, 174 (83%) were confirmed as true-positive by the gold standard. Immuno-PET showed a higher overall sensitivity (92%) than 18F-DOPA PET/CT (65%). Regarding metastatic sites, immuno-PET had a higher sensitivity than CT, 18F-DOPA PET/CT, or MRI for lymph nodes (98% vs. 83% for CT and 70% for 18F-DOPA PET/CT), liver (98% vs. 87% for CT, 65% for 18F-DOPA PET/CT, and 89% for MRI), and bone (92% vs. 64% for 18F-DOPA PET/CT and 86% for MRI), whereas sensitivity was lower for lung metastases (29% vs. 100% for CT and 14% for 18F-DOPA PET/CT). Tumor SUVmax at 60 min ranged from 1.2 to 59.0, with intra- and interpatient variability. Conclusion: This post hoc study demonstrates that anti-carcinoembryonic antigen immuno-PET is an effective procedure for detecting metastatic MTC lesions. Immuno-PET showed a higher overall sensitivity than 18F-DOPA PET/CT for disclosing metastases, except for the lung, where CT remains the most effective examination.

Journal of Medical VirologyVolume 93, Issue 4 p. 1903-1904 LETTER TO THE EDITOR Rebuttal to overinterpretation of the antiviral results for human coronavirus 229E relative to severe acute respiratory syndrome coronavirus-2 by Rowpar Pharmaceuticals Craig Meyers, Corresponding Author Craig Meyers [email protected] orcid.org/0000-0001-8773-3976 Department of Microbiology and Immunology, Pennsylvania State College of Medicine, Hershey, Pennsylvania, USA Correspondence Craig Meyers, Department of Microbiology and Immunology, H107, 500 University Dr, Pennsylvania State College of Medicine, Hershey, PA 17033, USA. Email: [email protected]Search for more papers by this authorRichard Robison, Richard Robison Department of Microbiology and Molecular Biology, Brigham Young University, Provo, Utah, USASearch for more papers by this authorJanice Milici, Janice Milici Department of Microbiology and Immunology, Pennsylvania State College of Medicine, Hershey, Pennsylvania, USASearch for more papers by this authorSamina Alam, Samina Alam Department of Microbiology and Immunology, Pennsylvania State College of Medicine, Hershey, Pennsylvania, USASearch for more papers by this authorDavid Quillen, David Quillen Department of Ophthalmology, Pennsylvania State College of Medicine, Hershey, Pennsylvania, USASearch for more papers by this authorDavid Goldenberg, David Goldenberg Department of Otolaryngology, Pennsylvania State College of Medicine, Hershey, Pennsylvania, USASearch for more papers by this authorRena Kass, Rena Kass Department of Surgery, Pennsylvania State College of Medicine, Hershey, Pennsylvania, USASearch for more papers by this author Craig Meyers, Corresponding Author Craig Meyers [email protected] orcid.org/0000-0001-8773-3976 Department of Microbiology and Immunology, Pennsylvania State College of Medicine, Hershey, Pennsylvania, USA Correspondence Craig Meyers, Department of Microbiology and Immunology, H107, 500 University Dr, Pennsylvania State College of Medicine, Hershey, PA 17033, USA. Email: [email protected]Search for more papers by this authorRichard Robison, Richard Robison Department of Microbiology and Molecular Biology, Brigham Young University, Provo, Utah, USASearch for more papers by this authorJanice Milici, Janice Milici Department of Microbiology and Immunology, Pennsylvania State College of Medicine, Hershey, Pennsylvania, USASearch for more papers by this authorSamina Alam, Samina Alam Department of Microbiology and Immunology, Pennsylvania State College of Medicine, Hershey, Pennsylvania, USASearch for more papers by this authorDavid Quillen, David Quillen Department of Ophthalmology, Pennsylvania State College of Medicine, Hershey, Pennsylvania, USASearch for more papers by this authorDavid Goldenberg, David Goldenberg Department of Otolaryngology, Pennsylvania State College of Medicine, Hershey, Pennsylvania, USASearch for more papers by this authorRena Kass, Rena Kass Department of Surgery, Pennsylvania State College of Medicine, Hershey, Pennsylvania, USASearch for more papers by this author First published: 29 December 2020 https://doi.org/10.1002/jmv.26762Read the full textAboutPDF ToolsRequest permissionExport citationAdd to favoritesTrack citation ShareShare Give accessShare full text accessShare full-text accessPlease review our Terms and Conditions of Use and check box below to share full-text version of article.I have read and accept the Wiley Online Library Terms and Conditions of UseShareable LinkUse the link below to share a full-text version of this article with your friends and colleagues. Learn more.Copy URL Share a linkShare onEmailFacebookTwitterLinkedInRedditWechat No abstract is available for this article. REFERENCES 1 EPA. Registering disinfectants in response to coronavirus (COVID-19); 2020. https://www.epa.gov/coronavirus/disinfectant-use-and-coronavirus-covid-19. Accessed December 30, 2020. Google Scholar 2Bidra AS, Pelletier JS, Westover JB, Frank S, Brown SM, Tessema B. Comparison of in vitro inactivation of SARS CoV-2 with hydrogen peroxide and povidone-iodine oral antiseptic rinses. J Prosthodont. 2020; 29: 599-603. https://doi.org/10.1111/jopr.13220 10.1111/jopr.13220 PubMedWeb of Science®Google Scholar 3Bidra AS, Pelletier JS, Westover JB, Frank S, Brown SM, Tessema B. Rapid in-vitro inactivation of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) using povidone-iodine oral antiseptic rinse. J Prosthodont. 2020; 29: 529-533. https://doi.org/10.1111/jopr.13209 10.1111/jopr.13209 PubMedWeb of Science®Google Scholar 4Meister TL, Brüggemann Y, Todt D, et al. Virucidal efficacy of different oral rinses against severe acute respiratory syndrome coronavirus 2. J Infect Dis. 2020; 222: 1289-1292. https://doi.org/10.1093/infdis/jiaa471 10.1093/infdis/jiaa471 CASPubMedWeb of Science®Google Scholar 5Mohamed NA, BaharomN, Sulaiman WSW, et al. Early viral clearance among COVID-19 patient when gargling with povidone-iodine and essential oils—a clinical trial (Report No. NCT04410159, clinicaltrial.gov NCT04410159); 2020. Google Scholar Volume93, Issue4Special Issue on New coronavirus (2019‐nCoV or SARS‐CoV‐2) and the outbreak of the respiratory illness (COVID‐19): Part‐XIApril 2021Pages 1903-1904 ReferencesRelatedInformation

Abstract Background: Patients (pts) with metastatic triple-negative breast cancer (mTNBC) who have brain metastases represent a poor prognosis cohort with a high unmet clinical need. Sacituzumab govitecan (SG) is an antibody-drug conjugate composed of an anti-Trop-2 antibody coupled to SN-38, an active metabolite of irinotecan, via a unique hydrolyzable linker that allows for SN-38 release intracellularly and in the tumor microenvironment (bystander effect). SN-38 can cross the blood-brain barrier and is a drug partner in central nervous system (CNS) disease regimens (PMID: 18784279; PMID: 26080460). Although antibody-based therapy raises concerns regarding CNS penetration, activity with SG has been seen in intracranial xenograft models (Brenner Neurooncol Adv 2019). In a subgroup analysis from ASCENT, the efficacy and safety of SG were evaluated in pts with stable brain metastases. Methods: In the phase 3 ASCENT study (NCT02574455), 529 pts with mTNBC refractory to or relapsing after at least 2 prior chemotherapies were randomized 1:1 to receive SG (10 mg/kg IV on days 1 and 8 every 21 days) or single-agent treatment of physician’s choice (TPC; capecitabine, eribulin, vinorelbine, or gemcitabine) until disease progression or unacceptable toxicity. Brain MRIs were required in pts with known brain metastases who were eligible if they had stable CNS disease for ≥4 wk by MRI. Per protocol, stable disease was defined as ≥2 wk from discontinuation of antiseizure medication and corticosteroid dose (≤20 mg prednisone equivalent) that was stable or decreasing for ≥2 wk before randomization. In these pts, brain MRIs were required throughout the study. The primary endpoint was progression-free survival (PFS) per independent central review (RECIST v1.1) in brain metastases-negative pts. Secondary endpoints included PFS per investigator assessment, PFS in the full population (in pts with/without brain metastases) by central review, objective response rate (ORR), overall survival (OS), and safety. Results: Overall, 61 of 529 (12%) enrolled pts had stable brain metastases at screening and were randomized to SG (n=32) or TPC (n=29). Median age was 53 y for SG and 51 y for TPC; all pts were female and had a median of 5 prior anticancer regimens. In this subset, median PFS was 2.8 mo (95% CI, 1.5-3.9) for SG vs 1.6 mo (95% CI, 1.3-2.9) for TPC by central review, and median OS was 6.8 mo (95% CI, 4.7-14.1) for SG vs 7.5 mo (95% CI, 4.7-11.1) for TPC. ORR for SG vs TPC, respectively, was 3% (1/32) vs 0% by central review, with a clinical benefit rate of 9.4% vs. 3.4%. Stable disease was achieved in 15 (47%) pts with SG vs 9 (31%) pts with TPC. In 53 pts who received at least 1 dose of treatment (SG, n=30; TPC, n=23), any-grade treatment-emergent adverse events (>20% with SG) for SG vs TPC were fatigue (63% vs 52%), diarrhea (50% vs 13%), neutropenia (43% vs 35%), nausea (43% vs 26%), decreased appetite (30% vs 17%), decreased neutrophil count (33% vs 22%), anemia (23% vs 35%), alopecia (23% vs 13%), and constipation (23% vs 22%). There were no treatment-related deaths. Two pts treated with SG are continuing study treatment for 16.2 and 6.3 mo as of the data cutoff date. Conclusions: Data interpretation in this population with poor prognosis is limited by the small sample size. In this exploratory analysis of pts with brain metastases from the phase 3 ASCENT study, SG was numerically better than TPC for tumor response and PFS but not OS. The safety profile was similar to that of the population without brain metastases for both study arms. SG is currently under clinical investigation for pts undergoing elective craniotomy for breast cancer with brain metastases or recurrent glioblastoma (NCT03995706) based on promising preclinical and intracranial clinical data. Citation Format: Véronique Diéras, Robert Weaver, Sara M. Tolaney, Aditya Bardia, Kevin Punie, Adam Brufsky, Hope S. Rugo, Kevin Kalinsky, Tiffany Traina, Leonard Klein, Delphine Loirat, Filipa Lynce, Brooke Daniel, Foluso Ademuyiwa, Sara A. Hurvitz, David M. Goldenberg, Quan Hong, Martin Olivo, Loretta M. Itri, Lisa Carey. Subgroup analysis of patients with brain metastases from the phase 3 ASCENT study of sacituzumab govitecan versus chemotherapy in metastatic triple-negative breast cancer [abstract]. In: Proceedings of the 2020 San Antonio Breast Cancer Virtual Symposium; 2020 Dec 8-11; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2021;81(4 Suppl):Abstract nr PD13-07.

The coronavirus outbreak is not the first crisis to affect a large swath of the nation's population: the Great Depression, World War II, and the HIV epidemic did so previously. Of the national responses to each of these examples, perhaps the most relevant would be the Manhattan Project model, as proposed by Senator Edward J. Markey (D, MA) and Peter L. Slavin, MD, of Mass General Hospital.1 In 1943 the government diverted tens of billions of dollars from civilian programs to the project to build the atomic bomb. What the COVID-19 pandemic requires is the reverse: the diversion of a substantial chunk of the more than $700 billion appropriated for the Pentagon's military budget to the biomedical, public health programs desperately needed to limit the current coronavirus outbreak and prevent future pandemics. Congress needs to recognize the actual challenges to our national security and thereby sustain our people's health and promote a prosperous and just economy. We are not in danger of being invaded by Russians, Chinese, Venezuelans, or Iranians; we are in danger of having the fabric of our society undermined by our failure to invest in and protect our national health and welfare. (Am J Public Health. Published online ahead of print November 19, 2020: e1-e2. https://doi.org/https://doi.org/10.2105/AJPH.2020.306048).

Milatuzumab (hLL1) is a humanised IgG1κ antibody that reacts with a cell surface epitope of human CD74, the human leukocyte antigen (HLA) class-II associated invariant chain present on antigen-presenting cells (APCs), including B cells and dendritic cells.1 Although initially studied for oncologic malignancies,2–5 dysregulation of APCs may also occur in non-malignant disorders, and several preclinical studies showed that milatuzumab modestly inhibited B cell proliferation, enhanced spontaneous migration, alterations of adhesion molecule expression and chemotaxis important for lymphocyte recruitment,6 and also reduced production of interferon-α in stimulated peripheral blood mononuclear cells isolated from healthy donors and patients with systemic lupus erythematosus (SLE) (unpublished results). Migration inhibitory factor (MIF) is a cytokine that activates a multicomponent receptor comprising the CD74 ligand-binding …

Abstract Background: Trophoblast cell-surface antigen-2 (Trop-2) is highly expressed in many epithelial tumors, including triple-negative breast cancer (TNBC). Sacituzumab govitecan (SG) is an antibody-drug conjugate composed of an anti-Trop-2 antibody coupled to SN-38, the active metabolite of irinotecan, via a unique hydrolyzable linker that allows SN-38 release intracellularly and in the tumor microenvironment (bystander effect). SG received accelerated approval in April 2020 for the treatment of patients with metastatic TNBC (mTNBC) who received at least 2 prior therapies for metastatic disease. The most common adverse events (AEs) observed with SG are neutropenia and gastrointestinal toxicity, also seen with irinotecan. To provide further information on SG, additional safety analyses from ASCENT, a randomized, phase 3 confirmatory study of SG versus standard-of-care chemotherapy in patients with mTNBC, will be reported. Methods: 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. The primary endpoint was progression-free survival measured by central independent review per RECIST v1.1. Secondary endpoints included objective response rate, duration of response, overall survival, and safety. An exploratory analysis of incidence of grade 3-5 AEs by UGT1A1 genotype was also performed. Post-hoc analysis of the time to onset and duration of key AEs will be performed, and descriptive analyses on alopecia, nausea and vomiting will also be provided. Results: Exploratory safety analyses by UGT1A1 allele status will be shown as well as time to onset and duration of neutropenia and diarrhea. Further descriptive analyses on alopecia, nausea, and vomiting will be provided along with AE management strategies. Conclusions: 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. Citation Format: Hope S. Rugo, Sara M. Tolaney, Delphine Loirat, Kevin Punie, Aditya Bardia, Sara A. Hurvitz, Joyce O'Shaughnessy, Javier Cortés, Véronique Diéras, Lisa Carey, Luca Gianni, Martine J. Piccart, Sibylle Loibl, David M. Goldenberg, Quan Hong, Martin Olivo, Loretta M. Itri, Kevin Kalinsky. 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 [abstract]. In: Proceedings of the 2020 San Antonio Breast Cancer Virtual Symposium; 2020 Dec 8-11; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2021;81(4 Suppl):Abstract nr PS11-09.