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AVEO Reports Positive Results on Leukemia Drug, Shares Up

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Shares of AVEO Oncology (AVEO - Free Report) surged about 35% after the company along with partner Biodesix, Inc. announced positive results from phase Ib expansion cohort of ficlatuzumab in combination with cytarabine in patients with relapsed and refractory acute myeloid leukemia (AML). However, shares of the company have slumped 57.5% in the past year compared with the industry’s decline of 5.8%.

Ficlatuzumab is a potent hepatocyte growth factor (HGF) inhibitory antibody product candidate. The phase Ib study was designed to assess the safety, tolerability and preliminary efficacy of ficlatuzumab combined with cytarabine in AML patients who are refractory to first-line therapy (7+3) or have relapsed within one year of induction, a population known to have poor outcomes.

The maximally tolerated dose was 20 mg/kg of ficlatuzumab on day 1, followed by 2 g/m2 cytarabine daily on days 2-7. Of 12 patients who received ficlatuzumab and cytarabine at the maximally tolerated dose, one was non-evaluable and 6 achieved a complete response (CR). Of 18 patients enrolled in the study, 17 were evaluable and 9 achieved a CR. 

Elevated serum HGF level is an adverse prognostic factor, and these results showed that the anti-HGF antibody ficlatuzumab combined with cytarabine holds potential to affect outcomes in patients with relapsed or refractory AML.

As a result, the company looks forward to considering additional studies with its partner Biodesix as a potential next step for the program. AVEO and Biodesix have a worldwide agreement to develop and commercialize ficlatuzumab. 

AVEO is also developing ficlatuzumab in combination with Lilly’s (LLY - Free Report) Erbitux in a phase II investigation for treating metastatic head and neck squamous cell carcinoma.

There are other companies too engaged in getting their candidates approved for the treatment of AML. Agios Pharmaceuticals, Inc. (AGIO - Free Report) is looking to get Tibsovo’s label expanded to include the first-line treatment of AML in patients with an isocitrate dehydrogenase 1 (IDH1) mutation who are not eligible for standard therapy. Tibsovo is also being evaluated in combination with Celgene’s (CELG - Free Report) Vidaza for treating newly diagnosed AML patients who are ineligible for intensive chemotherapy. Agios plans to conclude enrollment in the study by 2020.


Zacks Rank

AVEO currently carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

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