Benzinga | Jul 13, 2020 04:01PM EDT

Immunomedics Expands Collaboration With Roche Evaluating Trodelvy In Combination With Tecentriq Into Urothelial And Non-Small Cell Lung Cancers

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-na?ve 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.