As discussed in part one of this two part series, both Verastem and AVEO appear to be going to the ASCO conference this weekend with minimal updates pertaining to their pipeline. With volatility and a depressed stock price of each company, this was rather disappointing. In part one, I covered Verastem’s presentation at ASCO, and here in part two, I will go over what it appears AVEO will be bringing to ASCO.
Today (June 1), AVEO will have a poster presentation titled: “Efficacy and safety of tivozanib in recurrent, platinum-resistant ovarian, fallopian tube or primary peritoneal cancer.” The link to the abstract can be found here. This phase two study evaluated tivozanib, a VEGF inhibitor, in several forms of gynecologic cancers. With 30 patients treated, partial responses (tumor shrinkage) were seen in four patients (ORR 13%), while twelve patients had stable disease (40%). Until we have the breakdown of responses by type of gynecologic cancer, it is hard to exactly quantify these results, but I am not overly impressed. It is good that a targeted agent like tivozanib demonstrates activity in this patient population, as tivozanib is likely better tolerated than chemotherapy. However, the efficacy of this phase 2 trial appears to be inline or below the activity seen with current agents used for recurrent, platinum resistant ovarian cancer (the type of cancer the majority of patients had). In various studies, bevacizumab demonstrated around 16% in patients with recurrent, platinum resistant ovarian cancer. Agents such as gemcitabine, pegylated liposomal doxorubicin, and paclitaxel have all shown response rates ranging 10% to 30%. So as you can see based on the data available at this time, it appears tivozanib has little benefit from the efficacy side of things in this indication, making its potential better tolerability its only upside. In my opinion, this is rather underwhelming, but may warrant further development. It is always possible the response numbers will be updated at ASCO, so that is something to keep an eye on.
The second study will be a poster presented on Monday, titled: “TIVO-3: Subgroup analysis of progression-free survival of tivozanib compared to sorafenib in subjects with refractory advanced renal cell carcinoma (RCC).” A link to the abstract is here. This analysis is from the phase 3 TIVO-3 trial, evaluating tivozanib in the third and fourth line setting for patients with metastatic renal cell carcinoma. While this progression free survival analysis is interesting to see, it really has no merit unless tivozanib can demonstrate and overall survival benefit for the TIVO-3 trial. This update will likely not come until later in 2019 after the planned August interim analysis. A lot rides on the overall survival data. This is highlighted by the FDA’s guidance and rhetoric provided at the end of Phase 3 meeting. Furthermore, there is the potential that if the there is no survival benefit, or a negative survival benefit, associated with tivozanib treatment in TIVO-3, the Committee for Medicinal Products for Human Use may take further regulatory action in Europe, where tivozanib is currently approved for use in the first line setting. Essentially, I interpret this as if the negative survival trend continues, tivozanib’s approval in Europe will be revoked, leaving AVEO with a candidate that will not be approved in the US, and has been pulled from the market in Europe. As you can imagine, with so much riding on the August analysis, this makes AVEO a very high risk investment.
What is peculiar, is yesterday AVEO’s stock price ran up nearly 30% to close at $0.85. This was on nearly 5 times average volume as well. Earlier this year, there were buyout rumors circulating regarding AVEO, but that would be rather risky for a company to pay for AVEO ahead of such a binary event. Furthermore, this pump in stock price was quickly met with a public offering, causing the stock price to return below $1. Other causes for the run-up could include excitation ahead of ASCO, a leak of updated data for the gynecologic posters, or a push to get the stock price closer to $1 in attempt to regain compliance with NASDAQ policy.
In conclusion, the results and data at ASCO are not very earth shattering. The largest data release for AVEO this year will be the survival analysis after the August interim analysis. With so much riding on that analysis, it is likely that it will determine the fate of the company. That means until then, the price movement and news will likely just be noise. That being said, this volatility will likely provide traders the chance to profit on the price swings, and should be added to individual’s watch lists for interested parties. While many hope for a buyout, I find it unlikely until after the August analysis to mitigate risk for the acquiring company. For further discussion on the previous AVEO buyout rumors, I would refer you to my past piece: Evaluating the Merits of AVEO’s Potential Purchase.
This is in no form a recommendation to buy/sell shares of mentioned companies.
I/we have no position in any of the stocks mentioned.
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