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Genmab (GMAB) Begins Phase III Study on Cervical Cancer Drug

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Denmark-based biotech Genmab A/S (GMAB - Free Report) announced that it has initiated a phase III study evaluating the investigational antibody-drug conjugate tisotumab vedotin as compared to chemotherapy for treating recurrent/metastatic cervical cancer in patients who have received one or two prior lines of systemic therapy.

The global, randomized innovaTV 301 study is designed to evaluate the efficacy of tisotumab vedotinas compared with physicians’ choice single agent chemotherapy for the given indication. The study will enroll around 482 cervical cancer patients who have received one or two prior lines of systemic therapy for their metastatic disease. The primary endpoint of the study is overall survival.

Notably, the innovaTV 301 study will serve as a confirmatory study for a potential accelerated approval of tisotumab vedotin in the United States and also support regulatory filings for global marketing approval for recurrent cervical cancer.

Shares of Genmab have surged 90.6% in the past one year compared with the industry’s increase of 5.6%.

price chart for GMAB


Per the company, currently, there is no established standard of care for women with metastatic cervical cancer whose disease has progressed following the first or second line of treatment. As a result, if successfully developed and upon potential approval, tisotumab vedotin can become a safe and effective treatment option for the given patient population.

We note that Genmab is developing tisotumab vedotin in collaboration withSeagenInc. (SGEN - Free Report) . The companies share all costs and profits equally for the product. The innovaTV 301 study will be sponsored and conducted by Seagen in collaboration with Genmab, European Network of Gynaecological Oncological Trial Groups and the Gynecologic Oncology Group.

Apart from cervical cancer, tisotumab vedotin is being investigated as monotherapy in a range of solid tumors including ovarian cancer and in combination with commonly used therapies for metastatic cervical cancer.

Zacks Rank & Stocks to Consider

Genmab currently carries a Zacks Rank #2 (Buy). Top-ranked stocks in the biotech sector include Alkermes plc (ALKS - Free Report) and Blueprint Medicines Corporation (BPMC - Free Report) , both carrying a Zacks Rank #1 (Strong Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.

Alkermes’ earnings estimates have been revised 8.3% upward for 2021 over the past 60 days. The stock has increased 1.4% in the past year.

Blueprint Medicines’ loss per share estimates have narrowed 1.6% for 2021 over the past 60 days. The stock has rallied 28.7% in the past year.

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