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Immunomedics' Sacituzumab Govitecan Gets Fast Track Tag for UC

Immunomedics, Inc. IMMU announced that the FDA has granted a Fast Track designation to its lead candidate sacituzumab govitecan for the treatment of adult patients with locally advanced or metastatic urothelial cancer (mUC), having received a PD-1/PD-L1 inhibitor and a platinum containing chemotherapy in the neoadjuvant/adjuvant, locally advanced or metastatic setting including those who are ineligible for platinum and previously received a PD-1 or PD-L1 inhibitor in the neoadjuvant/adjuvant, locally advanced or metastatic setting.

Immunomedics is currently evaluating sacituzumab govitecan in the phase II TROPHY-U-01 study for addressing patients with mUC. In October 2019, the company presented interim data at the European Society for Medical Oncology (ESMO) Annual Congress from the same.

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 outcomes are consistent with the previously-reported efficacy of sacituzumab govitecan for mUC.

Meanwhile, Immunomedics already completed enrollment for the full cohort of 100 patients with prior platinum-based and PD-1/PD-L1 inhibitor therapies. Top-line findings from the same are expected in the second half of this year.

Per the company, recruitment for the second cohort of 40 cisplatin-ineligible patients is expected to be completed later in 2020. Notably, the company recently broadened the study to include a third cohort of PD-1 or PD-L1 inhibitor-naïve patients to evaluate sacituzumab govitecan in combination with Merck’s MRK Keytruda (pembrolizumab).

Shares of Immunomedics have lost 10.7% so far this year compared with the industry’s decrease of 7.5%.


Earlier this week, Immunomedics announced that a late-stage study on sacituzumab govitecan will be halted due to the compelling evidence of efficacy. The decision was based on a unanimous recommendation by the independent Data Safety Monitoring Committee (DSMC) following its recent routine review of the ASCENT study. Shares of the company soared following this news.

We remind investors that sacituzumab govitecan is presently under review with the FDA for the treatment of patients with metastatic triple-negative breast cancer (mTNBC), who received two prior therapies for metastatic disease. A decision from the regulatory body is pending on Jun 2, 2020.

Zacks Rank & Stocks to Consider

Immunomedics currently carries a Zacks Rank #3 (Hold). Better-ranked stocks in the biotech sector include Acorda Therapeutics, Inc. ACOR and Celldex Therapeutics, Inc. CLDX, both sporting a Zacks Rank #1 (Strong Buy).You can see the complete list of today’s Zacks #1 Rank stocks here.

Acorda’s loss per share estimates have been narrowed 8.8% for 2020 and 11.1% for 2021 over the past 60 days.

Celldex’s loss per share estimates have been narrowed 12.5% for 2020 and 12.8% for 2021 over the past 60 days.

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