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Biotech / Medical : Immunomedics (IMMU) - moderated
IMMU 16.59-2.7%Sep 20 12:00 AM EDT

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To: ladyPI who wrote (52478)9/12/2019 5:05:15 PM
From: Fitzhughlaw26 Recommendations

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I know it was a rhetorical question - but wait, there's more! The "sleeper" in the PR is that Cora Sternberg is joining Dr. Tagawa in the presentation of the UTC data, and here's something about her issued in January by Weill Cornell Medicine:

World-Renowned Medical Oncologist Cora Sternberg, M.D. Joins the Englander Institute for Precision Medicine as Clinical Director

The Englander Institute for Precision Medicine (EIPM) is excited to announce that world-renowned medical oncologist Cora Sternberg, M.D., has joined our staff as Clinical Director.

Dr. Sternberg is a leading international researcher and expert in the field of medical oncology, genitourinary cancers, and drug development. Before joining the EIPM, she became well-known for her influential work in developing novel therapies and targeted agents for the treatment of prostate, renal and bladder cancers while working as Chief of the Department of Medical Oncology at the San Camillo-Forlanini Hospital in Rome, Italy, and as adjunct Professor of Oncology at La Sapienza University in Rome. Dr. Sternberg has published extensively with over 375 articles and holds a distinguished position as a core faculty member of the European School of Oncology (ESO). She has received the European Society of Medical Oncology ESMO Award for Outstanding Contribution to the Development of Medical Oncology. She also received the honor of being elected as the 2019 chairman of the nominating committee of ASCO’s board of directors.
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She also published an article (https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6218109/) last October after the ESMO conference in Germany, and here's an excerpt:

Clinical Trials Corner

Piyush K. Agarwal, MD, Associate Editor, Bladder Cancer, Head, Bladder Cancer Sectiona and Cora N. Sternberg, MD, FACP, Associate Editor, Bladder Cancer, Clinical Director, Englander Institute for Precision Medicineb

Author information Article notes Copyright and License information Disclaimer

aUrologic Oncology Branch, National Cancer Institute, Bethesda, MD, USA
bWeill Cornell Medicine, New York-Presbyterian, New York, NY, USA

Dear Readers,

The European Society for Medical Oncology just completed its annual meeting in Munich this month and we would like to highlight several trials presented during this meeting. In the previous issue, we previously discussed the antibody-drug conjugate enfortumab vedotin and the pan FGFR inhibitor INCB054828.

Study Title: A Phase I/II Study of IMMU-132 (hRS7-SN38 Antibody Drug Conjugate) in Patients With Epithelial Cancers

Clinicaltrials.gov identifier: NCT01631552

Sponsor: Immunomedics, Inc.

Enrollment: 250

Rationale: Patients with advanced epithelial cancers, including metastatic urothelial cancer (mUC), have a poor prognosis and this phase I/II trial looks at the safety and efficacy of a novel antibody-drug conjugate, IMMU-132 (hRS7-SN38), also known as Sacituzumab Govitecan. The antibody, hRS7, is a humanized anti-Trop-2 monoclonal antibody attached to SN38 which is the active metabolite of irinotecan (CPT-11). The drug targets Trop-2 which is overexpressed in aggressive epithelial cancers including up to 83% of urothelial tumors and the conjugate binds to Trop-2 and delivers the active metabolite of a topoisomerase I inhibitor.

Study Design: The Phase I/II trial included an expansion cohort of 41 patients with metastatic urothelial cancer that progressed after one or more prior systemic therapies. Patients were treated until progression or unacceptable toxicity.

Endpoints: The primary endpoint was safety and antitumor efficacy was the secondary endpoint.

Results: This was a heavily pre-treated cohort as patients received a median of 3 prior therapies including prior platinum chemotherapy in up to 93% of patients. Furthermore, 34% of patients had received a checkpoint inhibitor (CPI). Overall, the treatment was highly tolerable with grade 3-4 neutropenia being the most commonly seen adverse event (AE) in 39%. The overall response rate (ORR) was 34% with 2 complete responses. The response rate was 29% in patients who had received a previous checkpoint inhibitor. The median overall survival was 16.1 months.

Ongoing Trials: TROPHY-U-01 ( NCT03547973) is a single-arm, open-label, global phase 2 trial evaluating the antitumor activity and safety of Sacituzumab Govitecan (IMMU-132) in 140 patients with advanced urothelial cancer after progression on platinum-based chemotherapy or anti-PD-1/PD-L1 checkpoint inhibitor therapy. The primary cohort (progression after platinum chemotherapy and CPI) will enroll 100 pts in a Simon 2-stage design with >90% power accounting for dropouts to exclude the null hypothesis or ORR <12%. A second cohort (40 pts) will comprise cisplatin-ineligible pts who received prior CPI. The primary objective is ORR assessed by central review per RECIST 1.1. Secondary objectives include response duration, PFS, OS, and safety/tolerability. Enrollment began in August 2018.

Comments: Similar to data presented at ASCO 2018 for another antibody-drug conjugate, enfortumab vedotin, this trial demonstrates that IMMU-132 (hRS7-SN38), Sacituzumab Govitecan, also has good activity in patients who have not only failed prior platinum chemotherapy but also in patients who have failed prior checkpoint inhibitor therapy. The ongoing trial will further establish its activity.

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I think the fact that she is presenting along with Dr. Tagawa is a good indicator that she likes the "activity established" since then, and thus her support for SG. With her credentials, that is a big plus for the company.
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