Welcome to another edition of "3 Things in Biotech You Should Learn Today," a daily digest dedicated to helping you keep up with science that may not be on your radar. As always, there's a lot to consider after the weekend, as the news purveyors blitz us with heavy-hitting stuff, such as...
Clovis Oncology takes another step in ovarian cancer
Three companies currently have an approved inhibitor of an enzyme called PARP for the treatment of ovarian cancer in some setting. There is AstraZeneca's (NYSE:AZN) olaparib and TESARO's (NASDAQ:TSRO) niraparib, both of which have had a lot of high-profile press over the past year.
Clovis Oncology (NASDAQ:CLVS) is no slouch in this arena, either, with its own entry to the space, rucaparib. All three companies, AZN, TSRO, and CLVS are jockeying for position in the ovarian cancer space, specifically in the setting of "platinum-sensitive" relapse. This is after a patient progresses on platinum-based chemotherapy and then achieves another response with treatment. TSRO was the first to receive an approval in this specific setting earlier this year.
But now CLVS may be about to join that fray. Whereas before rucaparib had accelerated approval as treatment for patients who have progressed on two or more lines of therapy, results from ARIEL3 show favorable PFS for maintenance therapy in the platinum-sensitive disease setting.
Looking forward: This certainly puts some heat on competitors, as it was easy to sort of write off rucaparib in light of rather good efficacy findings for olaparib and stellar results for niraparib. Now CLVS is poised to get a jump even on AZN in market share. It could also mean good things for FMI, as an expanding patient pool increases demand for their test. If approved, this should help offset the $142 million in settlement losses CLVS has set aside for litigation surrounding rociletinib's failure due to safety concerns.
Seattle Genetics bows out of AML therapy study
Seattle Genetics (NASDAQ:SGEN) has been a heavy hitter in certain forms of hematologic malignancy, most notably in Hodgkin lymphoma with its successful product brentuximab vedotin. There was hope they could carry the momentum in developing antibody-drug conjugates into other disease areas, with one area being in treatment for acute myeloid leukemia (AML). SGEN's entry into this space was vadastuximab talirine, which targets CD33.
At ASH 2015, SGEN showed some encouraging phase 1 trial data, prompting initiation of a phase 3 study.
But then came the clinical hold in late December 2016 due to potential liver toxicity, a hold lifted in March of this year.
Unfortunately, vadastuximab has reached the end of the line, as SGEN announced it would be shutting down the phase 3 study due to an observed increase in death due to infection upon analysis of unblinded data.
Looking forward: This is a definite setback for SGEN and for AML research on the whole. Imagine being an investigator finally getting a chance to look at the data you've been waiting on for years, only to find out the drug led to deaths of patients. It's very disheartening to think about, and it's definitely sad that this area of high unmet need sees another promising candidate fall at its feet.
Rigel Pharmaceuticals gets in the last steps for ITP
In happier news, Rigel Pharmaceuticals (NASDAQ:RIGL), a biotech specializing in therapies for uncommon autoimmune disorders, has reached the last leg of a journey for its lead drug candidate, fostamatinib. This agent works by blocking an enzyme called the splenic tyrosine kinase (NYSE:SYK), which is an important regulator of immune cell signaling.
Previously, a phase 3 study of fostamatinib in immune thrombocytopenia purpura reached its primary endpoint.
Now, RIGL has announced that the FDA has accepted their new drug application for fostamatinib, with an expected response date of April 18, 2017. If approved, this will be the first drug that RIGL brings to market, but it is certainly a milestone just to reach this stage, and it's going to be a long wait for the company until that PDUFA action date.
Looking forward: Oh, to be a shareholder in RIGL right now, with exciting news that still means a rather long wait if you're impatient. Ten months might seem like just about forever, but it's going to come up quickly. And previously announced clinical trial results suggest it could indeed receive approval, as a non-biologic based drug approach to helping platelet levels recover. We'll just have to see, but clearly RIGL is confident enough in its approach to go through the arduous task of getting an NDA submitted, which is certainly a good sign.
So the beginning of the week starts off eventful. For my money, the rucaparib news is the biggest, as it has pretty big implications for the management of ovarian cancer, now that the United States might finally see multiple drugs in the same setting, whereas this was not true before. Oddly enough, it WAS true in Europe, so it's a narrative that is a bit weird.
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