AVEO Pharmaceuticals, Inc. (NASDAQ:AVEO) issued a regulatory update after a meeting with the U.S. FDA to discuss data from the August 2019 OS analysis of the TIVO-3 study. The company also issued an update on its proposal to advance with a New Drug Application for tivozanib.
The TIVO-3 study was planned to resolve the FDA’s concerns pertaining to the OS trend in the TIVO-1 study. In the TIVO-1 study, the firm’s initial RCC pivotal study, the FDA noted that the inconsistent progression-free survival and OS data and imbalance in post-trial treatments made the study results inconclusive and uninterpretable when making a risk-benefit evaluation necessary for drug approval.
Final OS Analysis in 2Q20
AVEO earlier reported that the TIVO-3 study met its primary objective of showcasing a notable improvement in PFS. The trial also showed a considerable improvement in the secondary objective of ORR. The August 2019 assessment of the secondary objective of OS was the second pre-specified interim OS assessment of the TIVO-3 study and demonstrated an updated OS hazard ratio of 0.99. It was calculated at two years from the last subject registered in the study.
In the FDA’s initial feedback, based on its evaluation of the totality of proof showcased to date, the FDA stated that the firm should not file an NDA presently. It was alarmed about the data of TIVO-3 study related to the overall advancement of tivozanib. The FDA stated that AVEO’s current interim OS data fails to resolve the FDA’s apprehensions over detriment and that the data may worsen with a final assessment at 263 events.
AVEO plans to present to the FDA a revision to the SAP for the last OS analysis followed by an NDA filing in 1Q2020. AVEO expects to post the final OS assessment in June 2020 built on a May 1, 2020, deadline. It is at this point the firm expects that the trial will reach around 263 OS events. AVEO and the FDA agreed that if the final assessment gets an OS HR above 1, the firm will pull out its NDA filing.