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Immunomedics (IMMU) Reports Interim Urothelial Cancer Data

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Immunomedics, Inc. (IMMU - Free Report) announced some corporate updates. The company presented interim data at the European Society for Medical Oncology (ESMO) Annual Congress from the phase II TROPHY-U-01 study — which evaluated sacituzumab govitecan in in  patients with metastatic urothelial cancer (mUC) who had relapsed or are refractory to immune checkpoint inhibitors (CPI) and platinum-based chemotherapy.

The interim results showed that sacituzumab govitecan demonstrated an overall response rate (ORR) of 29% in 35 patients with mUC, who had relapsed or are refractory to immune checkpoint inhibitors (CPI) and platinum-based chemotherapy. The interim results are consistent with the previously reported efficacy of sacituzumab govitecan in mUC. Based on these data, the company will be exploring registrational pathways with the FDA.

Though the data was positive, however, shares of the company fell 7% following the news as the investors felt that the efficacy data was inferior than the data reported by rival company Seattle Genetics’ (SGEN - Free Report) enfortumab vedotin. Enfortumab vedotin is being evaluated in combination with Merck’s (MRK - Free Report) PD-1/L1 inhibitor Keytruda (pembrolizumab) for addressing previously untreated patients with locally advanced/mUC who are not eligible for cisplatin-based chemotherapy. The data from the combination of Enfortumab vedotin and Keytruda showed better tumor shrinkage in the majority of the given patient population as opposed to the data on sacituzumab govitecan.

Shares of the company have lost 7% year to date compared with the industry’s decline of 5.5%.


Further, Immunomedics announced two deals, which address continuing unmet needs in breast cancer. The company inked a deal with Roche Holding AG (RHHBY - Free Report) to evaluate the safety and efficacy of the combination of Tecentriq (atezolizumab), a programmed cell death ligand 1 (PD-L1)-blocking checkpoint inhibitor, and sacituzumab govitecan in frontline treatment of patients with metastatic or inoperable, locally advanced TNBC. The companies will conduct a phase Ib/II study as part of MORPHEUS, Roche’s novel cancer immunotherapy development platform to develop combinations of cancer immunotherapies more rapidly and efficiently.

The company also inked a collaboration deal with GBG Forschungs-GmbH, Germany, to develop sacituzumab govitecan as a treatment for newly-diagnosed breast cancer patients who do not achieve a pathological complete response (pCR) following standard neoadjuvant therapy. The multinational, post-neoadjuvant phase III SASCIA study by GBG will introduce sacituzumab govitecan to breast cancer patients at an early stage of their disease.

Based on the remaining activities for the compilation of the BLA for sacituzumab govitecan and preparations for a pre-approval inspection, the company revised its resubmission guidance from early fourth quarter to the late November or early December timeframe.

Currently, Immunomedicsis a Zacks Rank #3 (Hold) stock.You can see the complete list of today’s Zacks #1 Rank stocks here.


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