Welcome to another edition of "3 Things In Biotech You Should Learn Today," a daily digest dedicated to helping you keep pace with the fast-moving world of pharmaceutical and biotechnology research.
Otsuka failure portends termination of an important AML studyCompany: Otsuka (OTCPK:OTSKF)
Therapy: Guadecitabine
Disease: Acute myeloid leukemia (AML); click here to learn more about this disease space!
News: Otsuka announced top-line findings from their pivotal ASTRAL-1 study, which is assessing the hypomethylating agent guadecitabine in patients with newly diagnosed AML who are not candidates for aggressive therapy. The study has failed to meet its co-primary endpoints of complete remission rate and overall survival, compared with physician's choice of low-intensity therapy.
Looking forward: Once a highly promising next-generation hypomethylating agent, guadecitabine is now relegated to other treatment settings, where hopefully Otsuka will be able to salvage the agent. Two other studies are ongoing, but this does not bode well for this one. This includes the use of guadecitabine in the treatment of myelodysplastic syndromes, underscoring the need for alternatives, which I'm sure is quite the comfort to Geron (GERN) shareholders.
Buy, sell, or hold? Being a fairly large company itself, Otsuka will probably be able to weather this news, even in the event of a collapse of the guadecitabine project. I wouldn't strongly consider changing my investing strategy based on this news.
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Pfizer and Merck KGaA get moving with their ovarian cancer studyCompany: Pfizer (PFE) and Merck KGaA (OTCPK:MKGAY)
Therapy: Avelumab
Disease: Ovarian cancer
News: PFE announced as part of their earnings release that the first patient has been dosed in the phase 3 JAVELIN Ovarian PARP study, which is assessing the combination of avelumab and their PARP inhibitor talazoparib for use in untreated, advanced ovarian cancer. The study will enroll patients to receive avelumab plus chemotherapy, followed by maintenance with avelumab and talazoparib.
Looking forward: To date, avelumab has not made as grand an entrance on the immune checkpoint inhibitor stage as its siblings from other big pharma companies. But it's not for lack of trying, as PFE is pursuing a lot of avenues to see where the drug may fit. This is a particularly exciting project, given the known efficacy of PARP inhibitors in ovarian cancer. However, to date we have not seen the approval of talazoparib in ovarian, and in fact we haven't yet seen any PARP inhibitor break into first-line ovarian cancer so far. This gives PFE the opportunity to make a two-pronged assault on the disease.
Buy, sell, or hold? If PFE can pull this one off, then avelumab could start to realize its promise, and they would also become competitive in the PARP space, two emerging blockbuster areas. However, it's going to take quite a while for this to be realized, and as such I wouldn't recommend buying based on this news alone.
Daiichi Sankyo gets the breakthrough nod from the FDA in AMLCompany: Daiichi Sankyo (OTCPK:DSKYF)
Therapy: Quizartinib
Disease: AML
News: DSKYF announced that the FDA has granted their Flt3 inhibitor quizartinib Breakthrough Therapy designation for the treatment of Flt3-positive AML. This designation was based on the positive findings from the QuANTUM-R study, which demonstrated prolonged overall survival compared with chemotherapy in a specific, high-risk form of Flt-3-positive AML.
Looking forward: This builds on the positive nods given by the FDA and EMA to DSKYF, including Fast Track and Orphan Drug designations, and they are hard earned. The field of Flt-3 inhibition has been frustratingly slow to pay off, but it is now starting to become one of the pillars of AML therapy for the percentage of patients who have this subgroup. (Again, you can read more on that in my expansive AML article). Pretty soon, we'll have an important outcropping of effective Flt-3 inhibitors, ushering in another generation of targeted therapy for AML.
Buy, sell, or hold? Honestly, I would consider placing Daiichi Sankyo on a short list of buy contenders. They have this agent, of course, which seems to be a winner, and they have an exciting pipeline of other oncology drugs that could pay off in a big way in the coming years.
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