Last Updated on April 3, 2019 by Kevin Douglass
Lymphoma Patients Want and Need A Better Quality Of Life
As a Lymphoma survivor, I can say unequivocally, that TO MUCH TIME is spent in the chemo wing, away from our families. Therefore, as patients and Doctors learn of the remarkable response rates oral
VSTM showing signs of consolidation while being oversold. The chart indicates an inverse head and shoulders, one of the most bullish chart patterns in wall street.
Verastem announced Tuesday, March 13, 2019, at 430 pm EST it will report fourth-quarter earnings for 2018. A conference call and webcast will go over sales numbers which have been anxiously awaited. Investor rhetoric has been neutral. Although,
Partners with VSTM have been releasing positive data, in which VSTM’s FDA first commercialized medication Copiktra (
In a recent review Brittany Lovely and Ian W. Flinn, MD, Ph.D. discussed the drugs potential impact on patients with CLL. Flinn is the director of lymphoma research at the Sarah Cannon Center for Blood Cancer at Tennessee Oncology and TriStar Centennial Medical Center, based in Nashville, Tennessee. He serves as the lead investigator of the DYNAMO and DUO studies in
Lovely: How Is duvelisib Different From Other PI3K Inhibitors?
Flinn: Duvelisib is an inhibitor for both the delta and gamma isoforms of PI3K. The only other currently approved PI3K inhibitor for CLL is idelalisib [Zydelig], which is a pure delta isoform inhibitor. We know that the delta isoform is important because it is expressed in the malignant cells, but the gamma isoform is important in the microenvironment that
Duvelisib is an inhibitor of both of these isoforms, and it has a direct effect on the malignant cells, as well as the microenvironment and, therefore, may have greater efficacy in this patient population.
Blood Journal Excerpt:
Recent preclinical and early clinical data on a PI3K-g–specificFrom BloodJournal.org
inhibitor suggest an acceptable safety profile in patients with
advanced malignancies. Within the context of dual PI3K-d,g
inhibition, the AE profile of duvelisib was manageable, with most treatment-emergent AEs presenting as low-grade events (grade 1-2). Many commonly observed AEs, such as infections and cytopenias, [are expected] in a heavily pre-treated population with advanced hematologic malignancies.
Duvelisib’s Patient Population Growing
108.7 million folks age 50-plus. This includes 76.4 million boomers (born 1946-64), compared with 49 million Gen Xers and 82 million millennials. Moreover, people 50-plus will continue to grow over the next decade to the tune of 19 million, vs. growth of only 6 million for the 18-49 population.” People age 50-plus approximate ~45% of the current population in the US. Keep in mind this statistic is different in Europe, Japan, and China where Verastem is working with regulators to get further approval. This population of patients usually have pre-diagnosed conditions that [must] be treated, before finding out they have the “C-word.AARP.org
Dynamo Study Results
The most recent study in indolent NHL included 129 patients with either follicular lymphoma (42.2%), SLL (67.9%), or marginal zone B-cell lymphoma (38.9%). All patients were refractory to rituximab and chemotherapy or radioimmunotherapy. Looking at each disease subtype, the overall response rates were 42%, 68%, and 39% for patients with follicular lymphoma, SLL, and marginal zone lymphoma, respectively.
The efficacy demonstrated byQuote by Dr. Gopal From The Division Of Medical Oncology A The University Of Washington regarding Dynamo
duvelisibmonotherapy is clinically meaningful, considering that nearly all patients had disease refractory to prior rituximab and chemotherapy, including the most recent prior therapy
According to the researchers, responses to
The most common treatment-emergent adverse events (TEAE) were diarrhea (48.8%), nausea (29.5%), neutropenia (28.7%), fatigue (27.9%), and cough (27.1%). Among patients with at least a grade 3 or higher TEAE (88.4%), neutropenia, diarrhea, anemia, and thrombocytopenia were the most prevalent.
Duvelisib Q4 2018 Sales Forecast
In Q3 of 2018, VSTM realized $0.5 million net sales revenue in 4 business days. If Verastem’s 50 sales reps each sold 1.5 boxes of Copiktra in 60 business days, then Q4 sales should hit ~$9M. This number seems rather high. Especially considering licensing fees and other costs of revenue.
We wouldn’t be surprised though to see a figure between $3.5-$5.0 million in net sales revenue. Raymond James Copiktra sales forecast data on Symphony projects at least $1.8 million. Furthermore, our calculation is foregoing any milestone payments are triggered by CSPC or Yakult pharmaceutical, and sales do not accelerate or decelerate from the rate in Q3 of 2018.
Implications For Investors
When Duvelisib received early approval from the FDA it came with a “Black-Box warning” reflecting that the medication had the potential for high toxicity. When talking about older patients in the Lymphoma/ Leukemia Society, we are talking about progression-free survival for as long as we can, no matter the way in which chemotherapy is given.
While speaking to a clinical trial investigator I was told a big reason we hear the term “progression-free survival” is that to use the word cure is going to be too much for the patient’s comorbidities (i.e. other chronic diseases or conditions the patient starts treatment with). Therefore, practitioners try to give patients the highest level of quality of life possible for as long as possible.
What Have We Missed?
Research suggests that the PI3k Delta/ Gamma inhibitor has the capability of still being able to treat the population with comorbidities, which brings me to my point. This is an area in which Verastem and its partners are finding Duvelisib is inherently successful.
When this population of patients is “diagnosed” these pre-diagnosed conditions, can still be treated. Therefore, Doctors in which I’ve talked to say “Copiktra is being used as 2nd line treatment and potentially some cases 1st.” Therefore, like ANY OTHER chemo medication, the patient will be treated for
Collectively these factors plus the fact they are trading near cash value indicates VSTM is undervalued.
Partnerships & Studies
VSTM has made major partnerships that have gone “under-the-radar” with the Lymphoma & Leukemia Society (LLS) which includes Stanford University, Dana- Farber Cancer Institute, Cancer Research UK, Merck, etc. Many of these institutions are looked to by prescribing oncologist for new lines of therapy for their patients.
For more insight into the splash oral duvelisib is making in the iNHL scene read this article published from the Cancer Network.
MS Money Move and it’s Chief Operating Officer who is a scientist and individual investor, as well as its affiliates are not registered financial advisors. Our posts should serve as educational material to help you conduct due diligence research. Posts and articles are not directives or recommendations to invest in any security. We reserve the right to buy or sell any security for ourselves without any notification except when required by law. We are not responsible for the action of our affiliates. Investment theses may change due to the variable nature of the securities market. Because of this there is great risk when investing in stocks and options which can result is capital loss. Additionally, past performance by MS Money Moves or any security is not a predictor of future performance. Everyone should conduct their own research and due diligence before making an investment decision. We recommend you consult a financial advisor regarding any investment action.
The biotech sector is especially volatile. Stock prices may fluctuate substantially based on material or nonmaterial developments. We encourage everyone to familiarize themselves with clinical trial processes, relevant terminology, FDA/SEC rules and regulations, and the general processes of drug & therapy development/approval. Always do independent research in a security prior to investing