Welcome to another edition of "3 Things in Biotech You Should Learn Today," a daily digest dedicated to helping you keep apprised of the fast-moving world of pharma and biotechnology.
Let's jump right in there!
Seattle Genetics bouncing back with lymphoma momentum?
When last we left Seattle Genetics (NASDAQ:SGEN), they had announced termination of development of a new antibody-drug conjugate in acute myeloid leukemia, due to safety challenges. That was only yesterday, in fact!
Now it feels like SGEN has redoubled its efforts into developing brentuximab vedotin across more indications.
Today, SGEN announced the filing of a supplemental NDA for brentuximab vedotin as treatment for cutaneous T cell lymphoma, which has a number of similarities to Hodgkin lymphoma, where it's already approved.
The filing is supported by data from the phase 3 ALCANZA trial, which was stellar enough to get the FDA to grant brentuximab vedotin breakthrough designation in this disease.
Looking forward: They're marching on now. With favorable phase 3 results, this looks like a strong candidate for supplemental approval. With breakthrough designation, the FDA has made it a substantial priority, which could speed the timeline up. This definitely bodes well for SGEN and for patients with this uncommon form of lymphoma.
Aveo completes enrollment in its pivotal trial
Aveo Pharmaceuticals (NASDAQ:AVEO) currently pins its hopes on the development of a multitargeted kinase inhibitor, tivozanib, in the management of kidney cancer. This puts it in the same class as approved therapies like sunitinib, sorafenib, and pazopanib.
And I was skeptical about another kinase inhibitor making an impact now that we have cabozantinib and nivolumab as treatment options lighting the world on fire in the kidney space. But AVEO continue to press on.
And they have good news! Enrollment in the pivotal TIVO-3 study, which is looking at tivozanib in refractory renal cell carcinoma, has completed. Not only that, in fact...it's complete two months ahead of schedule.
Looking forward: Count me in as one of those to hear the supposed "death rattle" actually be moneybags. Obviously, AVEO had to reach this point if they wanted to even sniff an approval. But now they're moving into a point of data maturity, and they're hopeful to have top-line data in 2018. Given the grim outlook for patients with kidney cancer, this timeline seems (unfortunately) reasonable.
Cabozantinib is not sitting still, either!
Exelixis (NASDAQ:EXEL) realized a significant coup by showing strong results with its MET inhibitor cabozantinib in relapsed kidney cancer, which places it in a class of its own with respect to small molecules.
Since its approval, one of the most important studies for this agent has been CABOSUN, which is assessing the use of cabozantinib in first-line treatment compared with sunitinib. Last year, EXEL announced that the study had reached its primary endpoint of progression-free survival benefit.
Now those findings have been confirmed by an internal review committee, which is an important milestone for this crucial study. You see, one of the biggest questions surrounding the use of these kinase inhibitors is which order is best to give them in. Now, with these results, it's looking more and more clear which is the most efficacious in the first line.
Looking forward: It can't be understated what a gain it would be to supplant sunitinib as first-line therapy in kidney cancer. This is a major market, and getting the first-line approval could mean becoming one of, if not the, dominant kinase inhibitor. It still remains to be seen exactly how these will all fit together now that nivolumab is on the scene, but these are all active areas of investigation.
Very cool news, especially as it relates to EXEL. Elucidating the perfect sequence of therapy will be a huge question that needs to be answered in light of new therapies.
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