Verastem Inc (NASDAQ: VSTM) is having an overwhelingly strong start to the trading session this morning, and for good reason. On Saturday, the company presented clinical data at the 23rd Congress of the European Hematology Association. With positive data presented, excited investors are reacting by sending the stock toward the top. Today, we’ll talk about:
- The data;
- what we’re seeing from VSTM as a result; and
- what we’ll be watching for with regard to the stock ahead.
VSTM Presents Data
As mentioned above, Verastem is having an overwhelmingly strong start to the trading session this morning after the company presented data over the weekend. In a press release, the company announced that it has provided one oral and three poster presentations at the 23rd Congress of the European Hematology Association (EHA). The event was held in Stockholm, Sweden from June 14th through June 17th.
In particular, VSTM provided data with regard to its lead product candidate duvelisib. Duvelisib is a first-in-class oral inhibitor of phosphoinositide 3-kinase (PI3K)-delta and PI3K-gamma. In the oral presentation, Dr. Matthew Davids of the Dana-Farber Cancer Institute highlighted data from a recent Phase Ib/II clinical study. During the study, duvelisib was being evaluated in combination with FCR (dFCR) as a frontline treatment in younger patients with chronic lymphocytic leukemia (CLL). Also, the company provided three poster presentations surrounding additional duvelisib data. These included crossover extension results from the Phase 3 DUO™ study in patients with relapsed or refractory CLL/small lymphocytic lymphoma (SLL)), new biomarker analysis on the tumor microenvironment modulation from the DUO study and the Phase 2 DYNAMOTM study in patients with refractory indolent non-Hodgkin lymphoma (iNHL), and dual PI3K-delta and PI3K-gamma safety activity of duvelisib in the CONTEMPOTM study in patients with untreated follicular lymphoma (FL) who are treated with duvelisib in combination with CD20 antibody immunotherapy. Of course, the data in all presentations provided proved to be overwhelmingly positive. Leading to excitement among investors. In a statement, Diep Le, MD, PhD, Chief Medical Officer at VSTM, had the following to offer:
Dr. Matthew Davids gave an oral presentation of new clinical data from the ongoing Phase Ib/II study evaluating duvelisib in combination with FCR (chemo-immunotherapy) in younger, fit CLL patients… The combination regimen achieved an overall response rate (ORR) of 94%, including 26% of patients experiencing a complete response or complete response with incomplete blood count recovery (CR/CRi), and 68% achieving a partial response. In addition, patients also experienced a high rate of bone marrow MRD negativity of 76%, which is significantly higher than historical data with FCR. Importantly, the results from this study demonstrated that duvelisib can be combined with a triple chemo-immunotherapy in the front-line setting with an acceptable safety profile.
In addition, the DUO crossover extension data presented build upon the previously reported positive Phase 3 DUO study results and further support duvelisib’s potential as an oral treatment option for patients with relapsed or refractory CLL/SLL. Post-crossover, oral duvelisib monotherapy demonstrated robust clinical activity with a 73% overall response rate (ORR) and a 15-month median PFS in the 89 patients that had previously received ofatumumab on DUO and subsequently progressed. Duvelisib monotherapy also demonstrated a manageable safety profile, with results from this study consistent with the well-characterized safety profile of duvelisib monotherapy in previous studies. It is encouraging to see such a robust response to duvelisib monotherapy, similar to response observed in the parent DUO study, in patients that had failed an additional line of therapy and needed a new treatment option. Collectively, the data presented at EHA this year continue to provide important insights to guide the future clinical development of duvelisib across a wide range of hematologic malignancies, both as a monotherapy and in combination with other agents.
What We’re Seeing From The Stock
As investors, one of the first lessons that we learn is that the news moves the market. With several bits of positive clinical data coming out of Verastem, it only makes sense that excited investors are sending the stock toward the top. Of course, our partners at Trade Ideas were the first to alert us to the gains. At the moment (8:21), VSTM is trading at $7.54 per share after a gain of $1.01 per share or 15.47% thus far today.
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What We’ll Be Watching For Ahead
Moving forward, the CNA Finance team will continue to keep a close eye on VSTM. In particular, we’re interested in watching the ongoing work to bring duvelisib to the market as data surrounding the treatment seems to be overwhelmingly positive to date. Nonetheless, we’ll continue to follow the story closely and bring the news to you as it breaks!
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