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.
AstraZeneca marks a new historic achievement in competitive lung cancer space
Company: AstraZeneca (AZN)
Disease: Non-small cell lung cancer (NSCLC)
News: AZN announced that the phase 3 PACIFIC trial has met its second primary endpoint, overall survival. Durvalumab given after definitive chemoradiation therapy for stage III NSCLC provides a survival benefit for patients. This builds on the original publication of these findings, which showed a substantial improvement in progression-free survival, with only a modest increase in toxicity.
Looking forward: Although it seems like a pretty iterative result (and judging by the trading for AZN immediately after the announcement, investors weren't overly excited for these data), but this is an important landmark for AZN, one that will take quite some time for competitors to catch up. If there was any doubt in a doctor's mind that a patient should receive durvalumab as part of their care for stage III NSCLC, that should now disappear. Big news for patients, and big news for AZN, whether investors see it or not.
bluebird bio lands a breakthrough in another rare genetic disorder
Company: bluebird bio (BLUE)
Disease: Cerebral adrenoleukodystrophy (CALD)
News: BLUE announced that their Lenti-D platform has been given breakthrough therapy designation by the FDA for the treatment of CALD. This designation was based on findings from the Starbeam Study, which was published last year in the New England Journal of Medicine. These data demonstrated improvement in function and survival in 15 of 17 patients treated with Lenti-D, without additional toxicity.
Looking forward: Obviously, this is a signal that the FDA highly values the results BLUE has attained in patients with CALD so far. Breakthrough therapy designation will grant this strategy greater access to the FDA, as well as procedural benefits that could significantly cut down on the time to submission. Moreover, they might qualify for accelerated approval under this designation. Given the substantial unmet need presented here, this makes sense to me, even though the evidence only includes a relatively small number of patients. It won't be long before we're chalking up another win for BLUE, I'd wager.
Genmab's CD20 drug fails to stick the landing in NHL
Disease: Rituximab-resistant indolent non-Hodgkin lymphoma (iNHL)
News: GNMSF announced that their phase 3 study investigating the second-generation CD20 antibody ofatumumab in combination with bendamustine failed to improve progression-free survival for patients with rituximab-treated iNHL.
Looking forward: Full data were not given as part of the press release (unsurprisingly), but this marks a continued failure to thrive for GNMSF's and NVS drug, particularly in the face of assault from Roche in the form of obinutuzumab, a glycoengineered CD20 antibody. It's disappointing that ofatumumab has failed to make a substantial mark in the hematologic malignancies, although it remains approved. But this is a likely signal that its labeling won't be expanded anytime soon.
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.
Editor's Note: This article discusses one or more securities that do not trade on a major U.S. exchange. Please be aware of the risks associated with these stocks.