The spectacular rehabilitation of Aveo's cancer drug tivozanib continues with E.U. approval as a treatment for advanced kidney cancer.
Not long ago, prospects for tivozanib were looking particularly bleak, with an FDA rejection, failed clinical trials and the defection of former partner Astellas threatening to consign the program to a lowly demise. Now, with European approval (PDF) in hand for renal cell carcinoma (RCC), Aveo's fortunes have been transformed, and shares in the biotech were on the up in premarket trading this morning.
The European Medicines Agency has cleared once-daily VEGF inhibitor tivozanib under the Fotivda brand name as a front-line treatment in adult RCC patients. That means it can be used in patients whose disease has progressed one line of cytokine therapy with interleukin-2 or interferon, provided they have not previously been treated with other drugs including VEGF or mTOR inhibitors.
The EMA approval is based on the results of the TIVO-1 trial, in which tivozanib was found to be better than Bayer/Onyx's VEGF inhibitor Nexavar (sorafenib) in extending progression-free survival (PFS) with fewer side effects. The FDA thought was not up to scratch when it turned down the drug in 2013, but the EMA's advisory committee interpreted the data differently, recommending approval earlier this year.
Fotivda will now be launched by E.U. licensee EUSA Pharma as a rival to Nexavar and other VEGF inhibitors—notably Pfizer's Sutent (sunitinib) and Novartis' Votrient (pazopanib)—as well as Pfizer's mTOR inhibitor Torisel (temsirolimus).
Despite the number of drugs already available for RCC, tivozanib's approval has been welcomed by oncologist Bernard Escudier, M.D., of the Gustave Roussy Institute in France, who said the drug is a "welcomed addition" to the RCC armamentarium and that the disease is "still in need of effective and well-tolerated new treatments."
Approval in the E.U. prompts a $4 million milestone payment from EUSA, with another $2 million in the offing each time one of five key member states grants reimbursement approval. On that score, however, things haven't gone according to plan, as earlier this month the U.K.'s National Institute for Health and Care Excellence (NICE) turned down Fotivda for first-line RCC in draft guidance, with a final verdict due before the end of the year.
With EU approval in hand, Cambridge, Massachusetts-based Aveo can now focus its attention even more firmly on securing approval in the U.S. market, with the results of the pivotal TIVO-3 trial due early next year, and a potential combination with Bristol-Myers Squibb's immuno-oncology blockbuster Opdivo (nivolumab). The two partners recently started a trial of the pairing in RCC, which has advanced to the phase 2 stage after encouraging preliminary data.
Aveo ended the second quarter of this year with around $40 million in cash, having raised $14 million from two financings in June, and said it has funding in place through to the end of 2018.