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Seattle Genetics Closes Enrollment in Cervical Cancer Study

Zacks Equity Research

Seattle Genetics, Inc. SGEN announced that it has completed enrollment in the phase II innovaTV 204 study on its pipeline candidate, tisotumab vedotin. The candidate is being evaluated as a monotherapy for the treatment of patients with advanced/metastatic cervical cancer, whose disease relapsed or progressed after the standard of care treatment.

Tisotumab vedotin is being developed in partnership with the Danish company, Genmab A/S GNMSF. The candidate is an antibody-drug conjugate (ADC), targeting the tissue factor antigen that delivers the cell-killing agent monomethyl auristatin E (MMAE) inside cancer cells.

This pivotal phase II program will support the candidate’s potential registration under the FDA's accelerated approval pathway for the given indication. On the fourth-quarter conference call, the company mentioned that it planned to complete its enrollment by mid-2019. This news comes slightly earlier-than-the-previously-expected time.

Notably, last June 2018, Seattle Genetics initiated the phase II innovaTV 204 evaluation of tisotumab vedotin for the given patient population. The candidate is also being evaluated for several other cancer types, both as a monotherapy and a combo regime. Currently, tisotumab vedotin is examined in a phase I/II probe in combination with other cancer agents for treating the first/second-line metastatic cervical cancer. Two other phase II studies are investigating the candidate for advanced solid tumors and platinum-resistant ovarian cancer.

Shares of Seattle Genetics have rallied 29.3% so far this year, outperforming the industry’s increase of 12.5%.

We would like to remind investors that last week, Seattle Genetics and its Japanese partner Astellas Pharma announced positive top-line results from the first cohort of the phase II EV-201 study on enfortumab vedotin. The candidate is being evaluated for addressing patients with advanced/metastatic urothelial cancer, who were previously treated with both a checkpoint inhibitor (PD-1/PD-L1) and platinum-based chemotherapy.

Both companies plan to submit a biologics license application (BLA) to the FDA for enfortumab vedotin later this year.

Another interesting candidate in Seattle Genetics’ portfolio is SEA-BCMA, which is being assessed in a phase I study for treating patients with relapsed or refractory multiple myeloma (MM).

Zacks Rank & Stocks to Consider

Seattle Genetics currently carries a Zacks Rank #5 (Strong Sell).

Better-ranked stocks in the healthcare sector include Celgene Corporation CELG and Kamada Ltd. KMDA, both sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

Celgene’s earnings estimates have been revised 1.5% upward for 2019 and 2.2% for 2020 over the past 60 days. The stock has surged 47.2% in the year so far.

Kamada’s earnings estimates have moved 34.3% north for 2019 and 5% for 2020 over the past 60 days. The stock has risen 14.6% so far this year.

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