Objective Response Rate (ORR) = 31% (Centrally Reviewed); 34% (Locally Assessed)
Median Duration of Response (DOR) = 9.1 Months (Centrally Reviewed); 7.6 Months (Locally Assessed)
Clinical Benefit Rate at 6 Months = 45% (Locally Assessed)
Submission of Biologics License Application (BLA) for Accelerated Approval of Sacituzumab Govitecan as Third-Line Treatment for mTNBC Remains on Track for First Quarter of 2018
SAN ANTONIO, Dec. 06, 2017 (GLOBE NEWSWIRE) — Immunomedics, Inc. (NASDAQ:IMMU) (“Immunomedics” or the “Company”) today announced that a blinded, independent review by an adjudication team of radiologists has determined an ORR of 31%, including six complete responses (CRs) and 28 partial responses (PRs), in 110 patients with mTNBC after receiving treatment with sacituzumab govitecan, the Company’s lead investigational antibody-drug conjugate (ADC), in a Phase 2 study. The independent centrally-reviewed (ICR) median DOR was 9.1 months. These efficacy data are summarized in the table below.
|Blinded ICR*||Locally Assessed|
|ORR||31% (6 CRs, 28 PRs)||34% (3 CRs, 34 PRs)|
|Median DOR||9.1 months||7.6 months|
* Scans from 56 patients with at least 20% tumor reduction based on local assessment were sent for blinded, independent central review. Reviewers were not informed patients had 20% tumor shrinkage or which lesions were target lesions by local reads.
“Given relapsed or refractory mTNBC is currently an unmet clinical need and standard therapies provide a very limited benefit of 10-15% ORR and about 2-3 months progression-free survival, we are very encouraged with the efficacy and safety data sacituzumab govitecan has consistently been showing in this late-stage setting,” commented Aditya Bardia, MD, MPH, Director of Precision Medicine and attending physician at Center for Breast Cancer, Massachusetts General Hospital, Harvard Medical School, Boston, MA, who presented the single-arm study in an oral presentation during the 2017 San Antonio Breast Cancer Symposium.
Michael Pehl, President and Chief Executive Officer-elect of Immunomedics, stated, “We believe the blinded independent adjudication affirms the significant clinical activity of sacituzumab govitecan as a single agent in the third-line setting for patients with relapsed or refractory mTNBC. We remain focused on bringing this important medicine to breast cancer patients expeditiously and on transforming Immunomedics into a fully integrated biopharmaceutical company, creating value for our stockholders. To that end, the completion of this Phase 2 study is the second major step in our preparation of a BLA to be submitted to the FDA for accelerated approval of sacituzumab govitecan in this very aggressive form of cancer.”
In addition to a robust median duration of response, nine responders were progression free for more than one year from start of sacituzumab govitecan treatment, four of which were longer than two years. As of data cutoff on June 30, 2017, twelve responding patients were still receiving sacituzumab govitecan.
Overall, patients benefit from sacituzumab govitecan treatment irrespective of age, onset of metastatic disease, or number of prior regimens. Most patients spent more time on sacituzumab govitecan treatment compared to the time spent on last prior therapy. These include 19 patients with prior checkpoint inhibitor therapies who reported an encouraging ORR of 47% (9 of 19) with sacituzumab govitecan. The table below summarizes the ORR of various subgroups.
|Onset of metastatic disease||<1.5 years||29% (16/55)|
|>1.5 years||38% (21/55)|
|Prior regimens for metastatic disease||3rd line||36% (16/45)|
|>4th line||32% (21/65)|
|Visceral Involvement at study entry||Yes||30% (26/88)|
|Trop-2 IHC (N = 62)||0-1 (weak, absent)||0% (0/5)|
|2-3 (moderate, strong)||40% (23/57)|
|No Trop-2 IHC||29% (14/48)|
|Prior checkpoint inhibitors||47% (9/19)|
These encouraging results will be part of a BLA package anticipated to be submitted in the first quarter of 2018 to the FDA for accelerated approval of sacituzumab govitecan as a third-line treatment for patients with mTNBC.
Sacituzumab govitecan has a predictable and manageable safety profile. Grade 3 or 4 adverse events with more than 5% frequency include neutropenia (41%), leukopenia (14%), anemia (10%), diarrhea (8%), and febrile neutropenia (7%). Side effects were managed with supportive medication or dose modifications. There were no treatment-related deaths.
At 8:00 pm Central Time today, Wednesday, December 6, 2017, Immunomedics will host an investor event at The Grand Hyatt, Room Republic B, San Antonio, TX. Leading the discussion on the current treatment landscape for mTNBC will be Harold J. Burstein, MD, PhD, Associate Professor of Medicine at Harvard Medical School, and medical oncologist at Dana-Farber Cancer Institute and Brigham & Women’s Hospital. Linda T. Vahdat, MD, MBA, medical oncologist at Memorial Sloan Kettering Cancer Center and Chief of Medical Oncology and Clinical Director of Cancer Services at Norwalk Hospital will review the Phase 2 results with sacituzumab govitecan in mTNBC. Michael Pehl, President and Chief Executive Officer-elect of Immunomedics will also be present to provide the Company’s strategic priorities. Audio and slides will be webcast live at https://immunomedics.com/investors/. Approximately two hours following the live event, a webcast replay will be available on the Company’s website for approximately 30 days.
Immunomedics is a clinical-stage biopharmaceutical company developing monoclonal antibody-based products for the targeted treatment of cancer, autoimmune disorders and other serious diseases. Immunomedics’ most advanced product candidate is sacituzumab govitecan (IMMU-132), an antibody-drug conjugate that has received Breakthrough Therapy Designation from the FDA for the treatment of patients with metastatic triple-negative breast cancer who have failed at least two prior therapies for metastatic disease. Immunomedics’ primary goal is to bring sacituzumab govitecan to market for the benefit of patients and the creation of stockholder value. For additional information on the Company, please visit its website at https://immunomedics.com/. The information on its website does not, however, form a part of this press release.
Cautionary note regarding forward-looking statements
This release, in addition to historical information, may contain forward-looking statements made pursuant to the Private Securities Litigation Reform Act of 1995. Such statements, including statements regarding clinical trials (including the funding therefor, anticipated patient enrollment, trial outcomes, timing or associated costs), regulatory applications and related timelines, out-licensing arrangements, forecasts of future operating results, potential collaborations, and capital raising activities, timing for bringing any product candidate to market, involve significant risks and uncertainties and actual results could differ materially from those expressed or implied herein. Factors that could cause such differences include, but are not limited to, the Company’s dependence on business collaborations or availability of required financing from capital markets, or other sources on acceptable terms, if at all, in order to further develop our products and finance our operations, new product development (including clinical trials outcome and regulatory requirements/actions), the risk that we or any of our collaborators may be unable to secure regulatory approval of and market our drug candidates, risks associated with the outcome of pending litigation and competitive risks to marketed products, and the Company’s ability to repay its outstanding indebtedness, if and when required, as well as the risks discussed in the Company’s filings with the Securities and Exchange Commission. The Company is not under any obligation, and the Company expressly disclaims any obligation, to update or alter any forward-looking statements, whether as a result of new information, future events or otherwise.
For More Information:
Dr. Chau Cheng
Senior Director, Investor Relations & Corporate Secretary
(973) 605-8200, extension 123