Aveo Pharmaceuticals – Where we go from here
AVEO Oncology (Nasdaq: AVEO) announced that the U.S. Food and Drug Administration (FDA) has approved FOTIVDA® (tivozanib) for the treatment of adults with relapsed or refractory advanced renal cell carcinoma (RCC) who have received two or more prior systemic therapies. FOTIVDA is an oral, next-generation vascular endothelial growth factor (VEGF) tyrosine kinase inhibitor (TKI).
In short, AVEO can now look forward to making some inroads into the $1B RCC market as a third or fourth line therapy in a crowded field of systemic therapies that include small-molecule tyrosine kinase inhibitor like Inlyta and checkpoint inhibitor immunotherapy drugs such as Keytruda and Bavencio which are often combined with Inlyta as an effective treatment of advanced RCC.
In their Phase-III Clinical trial, Tivozanib demonstrated a 44% improvement in median PFS, the primary endpoint, with a median PFS in the tivozanib arm of 5.6 months compared with 3.9 months in the sorafenib arm, and 27% reduction in risk of progression or death compared to sorafenib (hazard ratio (HR)=0.73, p=0.0165). Therefore, there’s definitely potential to replace sorafenib as the standard of care as a 3rd or 4th line therapy, but the most common treatment option at that stage of the disease is surgery called radical nephrectomy that involves removing the entire affected kidney, the attached adrenal gland, and any adjacent fat and involved lymph nodes or major blood vessels. Results from clinical trials have shown that radical nephrectomy appears to improve survival of patients with metastatic RCC
Rest of the Pipeline
Beyond this approval, AVEO is pursuing Tivozanib in combination with immunotherapy agents – which is a common practice in RCC. AVEO’s other late-stage asset, Ficlatuzumab looked promising in AML until AVEO suspended the study due to COVID -> https://www.fiercebiotech.com/biotech/aveo-gives-up-ficlatuzumab-acute-myeloid-leukemia-citing-covid-19
There may be potential for Ficlatuzumab and Cetuximab in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma (HNSCC), but I don’t see that trial getting an FDA nod until at least 2022.
The rest of the pipeline has some promising drugs but nothing close to commercialization and nothing out there that can sustain investor bullish sentiment.
|AVEO Pharmaceuticals (AVEO)
We think that AVEO is fairly valued at the $420M Market Cap as it has a has a decent shot are generating earnings based on the approval of FOTIVDA® as a treatment for late-stage RCC. However, there’s nothing exciting about the rest of the pipeline, and we don’t expect significant earnings unless this treatment moves up the chain as a combination therapy. This is a classic “Sell-the-news” opportunity for investors who have held on to this for a while, with nothing for new investors.