Morris Plains, N.J., May 13, 2020 — Immunomedics, Inc., (NASDAQ: IMMU) (“Immunomedics” or the “Company”), a leading biopharmaceutical company in the area of antibody-drug conjugates (ADC), today announced that its recently FDA-approved ADC, Trodelvy, showed clinical activity in cisplatin-ineligible patients with metastatic urothelial cancer (mUC) and in patients with previously-treated metastatic endometrial cancer (mEC).
“These early-stage study data highlight the potential broad utility of Trodelvy and strengthen our premise of targeting Trop-2 for the delivery of SN-38,” said Dr. Loretta M. Itri, Chief Medical Officer. “Trodelvy is now being developed for a broad spectrum of epithelial cancers, either independently or in close collaboration with key opinion leaders and corporate partners.”
Trodelvy in cisplatin-ineligible mUC
In TROPHY U-01 cohort 2, at a median follow-up of 6.8 months, Trodelvy produced an objective response rate (ORR) of 29 percent (95% confidence interval [CI], 12–54) in 21 patients with mUC who were platinum ineligible and had progressed after prior checkpoint inhibitor (CPI) therapy, which is consistent with the 29 percent observed in the interim results from TROPHY U-01 cohort 1 of 35 mUC patients who were previously exposed to platinum-based and CPI therapies. While median duration of response (DOR) was not reached at the time of data cutoff, median progression-free survival (PFS) was 5.5 months (95% CI, 1.7–7.3) and median overall survival (OS) was 11.1 months (95% CI, 4.9–not available). Top-line data from the full cohort 1 of 100 patients are expected to be available in the second half of 2020.
Trodelvy in previously-treated mEC
Preclinical studies have shown Trodelvy to have activity against chemotherapy-resistant EC and significant bystander effect against EC with heterogenous Trop-2 expression.1 To evaluate this activity clinically, mEC patients who progressed after more than one prior systemic therapy were enrolled into a Phase 1/2 single-arm basket study.
At a median follow-up of 12.7 months, treatment with Trodelvy resulted in an ORR of 22 percent (95% CI, 6.4–47.6) in 18 mEC patients that had a median 3.5 (range 2–6) prior lines of therapy. All patients had previously received platinum therapies. DOR of responders ranged from 9.1 to 26.6 months, with 2 of 4 responders having a duration of 18 months or longer. Median PFS and OS was 3.2 months (95% CI, 1.9–9.4) and 11.9 months (95% CI, 4.7–not available), respectively. Clinical benefit rate was 44 percent (95% CI, 21.5–69.2).
The safety profile of Trodelvy in these two cohorts were consistent with prior reports in other cancer indications, including key grade 3 or higher treatment-related adverse events of neutropenia, diarrhea, and febrile neutropenia. No events of interstitial lung disease, ocular toxicities, or grade 2 or higher neuropathy were reported. There were no treatment-related deaths.
Details of the poster presentations at ASCO20 Virtual Scientific Program:
Date: Friday, May 29, 2020
Time: 8:00 a.m. – 11:00 a.m. Eastern Time
- Early results of TROPHY U-01 cohort 2: sacituzumab govitecan (SG) in platinum-ineligible patients (pts) with metastatic urothelial cancer (mUC) who progressed after prior checkpoint inhibitor (CPI) therapy (Petrylak, et al.)
Session Title: Genitourinary Cancer—Kidney and Bladder
Abstract #: 5027
Poster #: 96
- Sacituzumab govitecan (SG) in patients (pts) with previously treated metastatic endometrial cancer (mEC): results from a phase 1/2 study (Santin, et al.)
Session Title: Gynecologic Cancer
Abstract #: 6081
Poster #: 252
- TROPiCS-03: A phase 2 open-label study of sacituzumab govitecan (SG) in patients with metastatic solid tumors (Saxena, et al.)
Session Title: Developmental Therapeutics—Molecularly Targeted Agents and Tumor Biology
Abstract #: TPS3648
Poster #: 378
- Perrone E, Manara P, Lopez S, et al. Sacituzumab govitecan, an antibody‐drug conjugate targeting trophoblast cell‐surface antigen 2, shows cytotoxic activity against poorly differentiated endometrial adenocarcinomas in vitro and in vivo. Mol Oncol. 2020 Mar; 14(3): 645–656. Published online 2020 Jan 14.
Immunomedics is a leader in next-generation antibody-drug conjugate (ADC) technology, committed to help transform the lives of people with hard-to-treat cancers. Our proprietary ADC platform centers on using a novel linker that does not require an enzyme to release the payload to deliver an active drug inside the tumor cell and the tumor microenvironment, thereby producing a bystander effect. Trodelvy, our lead ADC, is the first ADC the FDA has approved for the treatment of people with metastatic triple-negative breast cancer and is also the first FDA-approved anti-Trop-2 ADC. 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 expectations for the timing of the commercial launch of TRODELVY and the Company’s development of TRODELVY for additional indications, clinical trials (including the funding therefor, anticipated patient enrollment, trial outcomes, timing or associated costs), regulatory applications and related timelines, including the filing and approval timelines for BLAs and BLA supplements, out-licensing arrangements, forecasts of future operating results, potential collaborations, capital raising activities, and the 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 reliance on third-party relationships and outsourcing arrangements (for example in connection with manufacturing, logistics and distribution, and sales and marketing) over which it may not always have full control, including the failure of third parties on which the Company is dependent to meet the Company’s business and operational needs for investigational or commercial products and, or to comply with the Company’s agreements or laws and regulations that impact the Company’s business; the Company’s ability to meet post-approval compliance obligations (on topics including but not limited to product quality, product distribution and supply chain requirements, and promotional and marketing compliance); imposition of significant post-approval regulatory requirements on our product candidates, including a requirement for a post-approval confirmatory clinical study, or failure to maintain or obtain full regulatory approval for the Company’s product candidates, if received, due to a failure to satisfy post-approval regulatory requirements, such as the submission of sufficient data from a confirmatory clinical study; the uncertainties inherent in research and development; safety and efficacy concerns related to the Company’s products and product candidates; uncertainties in the rate and degree of market acceptance of products and product candidates, if approved; inability to create an effective direct sales and marketing infrastructure or to partner with third parties that offer such an infrastructure for distribution of the Company’s product candidates, if approved; inaccuracies in the Company’s estimates of the size of the potential markets for the Company’s product candidates or limitations by regulators on the proposed treatment population for the Company’s products and product candidates; decisions by regulatory authorities regarding labeling and other matters that could affect the availability or commercial potential of the Company’s products and product candidates; 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 relating to the COVID-19 pandemic in the U.S. and around the world; risks associated with litigation to which the Company is or may become a party, including the cost and potential reputational damage resulting from such litigation; loss of key personnel; 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.
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