Note: Subscribers to Avisol Capital Partners Total Pharma Tracker got an early look at this publication. Try for free today and see what we’re talking about! Here is some more information if you’re curious.
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.
Novartis gets its second CAR-T cell therapy approval
Company: Novartis (NVS)
Disease: Diffuse large B cell lymphoma (DLBCL)
News: NVS announced that the FDA has granted approval to its CD19 CAR-T cell therapy tisagenlecleucel for relapsed/refractory DLBCL. This adds the second approval for a technique that was approved for relapsed/refractory ALL last year. This approval was based on the pivotal JULIET study, which showed favorable response rates with long durations of response.
Looking forward: And the streak continues here in the states. Now this puts it in direct competition with Gilead (NASDAQ:GILD) for the first time, as it previously received approval in a similar setting. At this point, there doesn’t seem to be any indication that the techniques are much different in terms of efficacy or safety. Perhaps projected price? But Gilead’s option is estimated at about $100,000 cheaper, so I’m very curious to see how it intends to compete.
Very important news for NVS, and now it kicks off the first brush war in CAR-T cell therapy.
Karyopharm is the talk of the town with its myeloma news
Company: Karyopharm (KPTI)
Disease: Relapsed multiple myeloma
News: KPTI announced positive top-line data from its phase 2b STORM study, which is assessing its nuclear exportin inhibitor selinexor in heavily pretreated multiple myeloma. Selinexor has achieved an overall response rate of 25.4%, with median duration of response of 4.4 months. The therapy remained well tolerated, with no surprising toxicities observed. KPTI guided that it intends to submit a new drug application based on these findings.
Looking forward: You might feel that a 25.4% response rate is a little underwhelming, particularly in multiple myeloma, where there are now so many effective treatment options. But it’s important to remember that these patients are heavily pretreated, which at this time is typically taken to mean anywhere from 3 to 6 prior lines of therapy. And this is a pretty dire setting of therapy, so a new option with a remarkable mechanism of action. I think it’s the beginning of big things for KPTI.
You should definitely have this company on your watchlist if it isn’t already.
Amgen also brings out good myeloma news
Company: Amgen (AMGN)
Disease: Multiple myeloma
News: AMGN announced that the CHMP has granted a positive opinion on the label extension for carfilzomib to include the final overall survival results from ASPIRE, which demonstrated improved survival when adding the agent to lenalidomide-dexamethasone. This provides further validation among the national regulators with respect to overall survival.
Looking forward: This is an important extension of what clinicians and pharmacists will see in Europe. And this is a congested treatment space where several treatment options are available. AMGN needs to keep on the attack to prove that carfilzomib is the best treatment that can be given.
Iterative event, but good news for AMGN.
Author’s note: Thank you for taking some time out of your day to read some commentary on recent biotech happenings. I hope you’ll consider leaving a comment or a question in the section below! This is one way in which Seeking Alpha is able to gauge the effectiveness of its writers and the platform. So if you want to keep seeing more editions of “3 Things,” go ahead and participate!
As I mentioned above, I am now collaborating with Avisol Capital Partners on their Marketplace service known as the Total Pharma Tracker (TPT). Some of my work will be available to TPT subscribers either exclusively, or in advance. I will also collaborate in developing watchlists and other investment essentials. Please subscribe to TPT by clicking on this link – Total Pharma Tracker.
Disclosure: I/we have no positions in any stocks mentioned, and no plans to initiate any positions within the next 72 hours.
I wrote this article myself, and it expresses my own opinions. I am not receiving compensation for it (other than from Seeking Alpha). I have no business relationship with any company whose stock is mentioned in this article.