Immunomedics Expands Collaboration with Roche Evaluating Trodelvy™ (sacituzumab govitecan-hziy) in Combination with Tecentriq® (atezolizumab) into Urothelial and Non-Small Cell Lung Cancers
Immunomedics (NASDAQ: IMMU) announced an extension of its clinical collaboration with Roche to study Trodelvy, an anti-Trop-2 antibody-drug conjugate, in combination with Roche’s Tecentriq for patients with metastatic urothelial cancer and non-small cell lung cancer. The studies will evaluate the efficacy of this combination compared to standard treatments. Additionally, patient enrollment has begun for the Phase 2 NeoSTAR study focusing on localized triple-negative breast cancer, with pathological complete response as the primary endpoint.
- Extension of collaboration with Roche enhances research credibility.
- New Phase 2 NeoSTAR study initiated for Trodelvy in localized triple-negative breast cancer.
- Dependence on Roche's studies could delay operational outcomes.
- Clinical trials may face risks associated with patient enrollment and regulatory approval.
Companies have ongoing collaboration in first-line metastatic triple-negative breast cancer
Immunomedics also announces Phase 2 NeoSTAR study in neoadjuvant triple-negative breast cancer has begun patient enrollment
MORRIS PLAINS, N.J., July 13, 2020 (GLOBE NEWSWIRE) -- Immunomedics, Inc. (NASDAQ: IMMU) (“Immunomedics” or the “Company”), a leading biopharmaceutical company in the area of antibody-drug conjugates (ADC), today announced an extension of its current clinical collaboration with Roche to evaluate Trodelvy, Immunomedics’ anti-Trop-2 ADC, in combination with Tecentriq, Roche’s programmed cell death ligand 1 (PD-L1)-blocking checkpoint inhibitor (CPI), in patients with metastatic urothelial cancer (mUC) and metastatic non-small cell lung cancer (mNSCLC).
“Given that Trodelvy can cause tumor-cell death with possible neoantigen release, combining it with an immune-stimulating agent, such as atezolizumab, could potentially create a synergistic effect, which can lead to a promising therapeutic option,” said Dr. Loretta M. Itri, Chief Medical Officer of Immunomedics.
Under the terms of the extension, Roche will be conducting two open-label, multicenter, randomized Phase 1b/2 studies using its MORPHEUS platform. The MORPHEUS-mUC study will randomize CPI-naïve mUC patients who have failed platinum-containing chemotherapy to receive the Tecentriq plus Trodelvy combination or Tecentriq alone. The second study, Morpheus-Lung, will enroll CPI-experienced mNSCLC patients after failure with platinum-based regimen to receive either Tecentriq and Trodelvy or docetaxel alone.
“We are pleased to be expanding our partnership with Roche, a global leader in cancer therapy,” commented Dr. Behzad Aghazadeh, Executive Chairman of Immunomedics. “We believe these combination studies will build a strong foundation for early-line cancer treatment developments.”
Separately, Immunomedics also announces that the new Phase 2 NeoSTAR study initiated by Dr. Aditya Bardia at Mass General Cancer Center has enrolled the first patient with localized triple-negative breast cancer to receive Trodelvy before surgery to remove the tumor. Pathological complete response rate is the primary endpoint of this study, with disease-free survival and overall survival serving as secondary endpoints.
About Immunomedics
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, achieving full FDA approval based on our confirmatory data for TRODELVY, 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.
For More Information:
Dr. Chau Cheng
(862) 260-3727
ccheng@immunomedics.com
For Media Inquiries:
Darren Opland, Ph.D.
(646) 627-8387
Darren@lifescipublicrelations.com
FAQ
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