Last Updated on June 1, 2019 by Sultan Beardsley
Given Verastem’s (VSTM) depressing price movement since reaching $10 in 2018 and AVEO’s volatile start to 2019, neither company has brought forth any interesting data for presentation at ASCO 2019. Here in part-one of a two-part ASCO coverage series, I will briefly summarize the data Verastem intends to present in the coming days, and then in part two, I will discuss AVEO’s data.
Verastem is down over 85% since it reached highs in September of last year. This massive loss has likely been multi-factorial, starting with a very poor launch and turnover in leadership. Recently, we highlighted Verastem after its first quarter earnings report, and you can read about that here. Many retail investors and watchers (including myself) were hoping to see results from some of Verastem’s combination trials for its lead (only) commercial asset duvelisib and its clinical stage candidate defactinib at ASCO. Unfortunately, these expectations did not come to fruition. So, what is being presented at ASCO for Verastem?
Well, there will be a poster presentation on Monday morning titled “Effect of dose modifications on response to duvelisib in patients with relapsed/refractory (R/R) CLL/SLL in the DUO trial.” The link to the abstract is here. This really isn’t anything spectacular in my opinion. Typically, podium presentations are reserved for more big ticket items, and this being a poster, clearly wasn’t classified as ground breaking. Essentially, this abstract showed that patients who required dose reductions or dose interruptions showed similar responses and progression free survival when compared to their counter parts without dose interruptions or dose reductions.
While this is good news for patients who attempt therapy with duvelisib, it underscores the adverse events headwinds that Verastem has encountered in its launch. Claiming to be dual PI3K inhibitor, it is yet to be seen just how differentiated duvelisib is from other PI3K inhibitors. A second abstract will be presented at EHA on June 14th, which shows that duvelisib may not be as well tolerated as originally thought, which goes back to why Verastem is reporting the response and progression free survival at ASCO if patients and prescribers are often encountering adverse events. The following is from the EHA abstract: “Idelalisib-treated patients experienced significantly more Grade>3, but not any-grade AST and ALT elevation than duvelisib-treated pts. Duvelisib-treated patients experienced significantly higher any-grade and grade>3 diarrhea + colitis, lower respiratory tract infection, anemia, and neutropenia; ant-grader mucositis, musculoskeletal pain, and thrombocytopenia; and grade>3 rash and fatigue than idelalisib-treated patients.” This is very much not what investors and those hopeful for duvelisib’s commercial success wanted to hear given the negative connotations surrounding idelalisib.
With regards to an update on defactinib, there are no abstracts available online for the compound. Furthermore, in Verastem’s press release, defactinib was not mentioned, so I am not expecting any updates at ASCO. The lack of defactinib abstracts at ASCO includes other focal adhesion kinase inhibitors (FAKi) that are in Verastem’s preclinical pipeline (such as VS-4718). There are several ongoing defactinib trials, but it is very unclear when we should expect updates. Either way, defactinib is a wild card, but I do not have high hopes for the compound.
Anyway you look at it, the combination of management’s discussion of launch headwinds during the last conference call, publishing on patient response despite adverse events, and data suggesting duvelisib may not be much differentiated from the notorious idelalisib raise concerns regarding duvelisib’s future commercial success. It is likely we will not see any meaningful duvelisib data releases till later in 2019, given the timing of the large conferences. That means we will be limited to commercial developments, which have been bleak so far, and any surprise defactinib updates. There is the alluded to ex-US partnership potentially, but it is uncertain how this will unfold. With such a depressed price at this point, I am uncertain the lackluster news will cause much price movement downward. For a complete overview of Verastem and duvelisib following its most recent earnings report, please refer to our previous piece: Verastem’s Earnings: Is It a Buy Now? For further discussion of AVEO’s ASCO presence, please stop back tomorrow for part two of this ASCO coverage.
This is in no form a recommendation to buy/sell securities.
I/we have no position in any of the stocks mentioned.