AVEO Pharmaceuticals, Inc.’s (AVEO) shares fell 9% after the company announced that data from a planned interim analysis of the phase II BATON (Biomarker Assessment of Tivozanib in ONcology) – CRC (colorectal cancer) study on oncology candidate, tivozanib, showed that the study is unlikely to meet the primary endpoint.
The open-label, randomized study is comparing the efficacy of tivozanib plus modified FOLFOX6 (a standard chemotherapy regime) with Roche’s (RHHBY) Avastin (bevacizumab) plus modified FOLFOX6 in treatment naïve advanced metastatic CRC patients.
This is the latest in tivozanib-related setbacks for AVEO. Earlier this year in June, AVEO and partner, Astellas Pharma, Inc. (ALPMY), had received a complete response letter (CRL) from the U.S. Food and Drug Administration (:FDA) for tivozanib for advanced renal cell carcinoma (:RCC). The FDA informed AVEO that the new drug application (:NDA) was not approvable in its present form. Following the CRL, AVEO decided to discontinue tivozanib development for the advanced RCC indication.
The company consequently announced a restructuring initiative to reduce workforce by 62%.
Tivozanib is also being studied in patients suffering from locally recurrent or metastatic triple negative breast cancer (phase II). However, the enrolment process for the study has been slower than expected.
We are concerned about AVEO’s future prospects given disappointing interim data from the BATON – CRC. After the failure of tivozanib for RCC, the company was banking heavily on the success of the CRC trial. We have low hopes from the breast cancer study as well. AVEO and Astellas are analyzing the data from the interim analysis (including biomarker data) of BATON – CRC.
AVEO carries a Zacks Rank #4 (Sell). Some better-ranked stocks include Actelion Ltd. (ALIOF) carrying a Zacks Rank #1 (Strong Buy).
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