Immunomedics and Roche have agreed to expand their clinical trial collaboration to evaluate sacituzumab govitecan-hziy (Trodelvy™), a Trop-2-directed antibody conjugated to a topoisomerase I inhibitor (SN-38), in combination with atezolizumab (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).
In April 2020, sacituzumab govitecan received accelerated approval in the United States for the treatment of adult patients with metastatic triple-negative breast cancer (mTNBC) who have received at least two prior therapies for metastatic disease.
Adaptive platform trials
Under the terms of the extension, Roche will be conducting two open-label, multicenter, randomized Phase Ib/II studies using its MORPHEUS platform.
The MORPHEUS platform is designed to identify early signals of clinical activity and, at the same time, establish proof-of-concept clinical data that supports the development of combination treatments. This comprehensive, adaptive clinical study* platform includes multiple, global, open-label, randomized, Phase Ib/II trials evaluating novel treatment combinations in patients with different tumor types.
The type-specific MORPHEUS study includes multiple cancer immunotherapy combination arms, comparing them with a single standard-of-care control arm to minimize the number of patients receiving the control treatment. The platform study aims to evaluate cancer immunotherapy combinations more efficiently than conventional trial designs.
The MORPHEUS-mUC study will randomize checkpoint inhibitor-naïve mUC patients who have failed platinum-containing chemotherapy to receive the atezolizumab plus sacituzumab govitecan combination or atezolizumab alone.
The second study, Morpheus-Lung, will enroll checkpoint inhibitor-experienced mNSCLC patients after failure with a platinum-based regimen to receive either Tecentriq and sacituzumab govitecan or docetaxel alone.
“We are pleased to be expanding our partnership with Roche, a global leader in cancer therapy,” commented Behzad Aghazadeh, Ph.D., Immunomedics Executive Chairman.
“We believe these combination studies will build a strong foundation for early-line cancer treatment developments,” he added.
Separately, Immunomedics also announces that the new Phase II NeoSTAR study initiated by Aditya Bardia, M.D., MPH, at Mass General Cancer Center has enrolled the first patient with localized triple-negative breast cancer to receive [sacituzumab govitecan] before surgery to remove the tumor.
The primary endpoint of this study is pathological complete response (pCR) rate with disease-free survival and overall survival serving as secondary endpoints.
* Adaptive platform trials (APTs) are designed to study multiple interventions in a perpetual manner. Interventions enter and leave the platform on the basis of a predefined decision algorithm.
A Study Evaluating the Efficacy and Safety of Multiple Immunotherapy-based Treatment Combinations in Patients With Locally Advanced or Metastatic Urothelial Carcinoma After Failure With Platinum-Containing Chemotherapy (MORPHEUS mUC) – NCT03869190
A Study Of Multiple Immunotherapy-Based Treatment Combinations In Participants With Metastatic Non-Small Cell Lung Cancer (Morpheus- Non-Small Cell Lung Cancer) (Morpheus Lung) – NCT03337698
Sacituzumab Govitecan In TNBC (NeoSTAR) – NCT04230109