3 Things In Biotech, May 26: Immunotherapy Strikes Lung Cancer Yet Again

by: Zach Hartman

AstraZeneca marks a new historic achievement in competitive lung cancer space.

bluebird bio lands a breakthrough in another rare genetic disorder.

Genmab's CD20 drug fails to stick the landing in NHL.

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)

Therapy: Durvalumab

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)

Therapy: Lenti-D

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

Company: Genmab (OTCPK:GNMSF) and Novartis (NVS)

Therapy: Ofatumumab

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.

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