3 Things In Biotech, April 18: Bristol Plows Ahead, Celldex Flops, Alkermes Gets A Surprise

Includes: ALKS, AZN, BMY, CLDX
by: Zach Hartman

Bristol-Myers shows more signs of life in lung cancer.

Celldex has a catastrophic setback.

Alkermes gets a surprise "come hither" from the FDA.

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Welcome to another edition of "3 Things In Biotech," a daily digest dedicated to helping you keep pace with the fast-moving world of pharmaceutical and biotechnology research.

Bristol-Myers shows more signs of life in lung cancer

Company: Bristol-Myers Squibb (BMY)

Therapy: Nivolumab

Disease: Non-small cell lung cancer

News: A bit of follow-up on yesterday's AACR blitz; BMY also presented updated findings from a neoadjuvant nivolumab study that was simultaneously published in the New England Journal. As it turns out, in this pilot study involving patients with operable non-small cell lung cancer, giving nivolumab did not negatively affect the ability to perform the surgery, and there was significant evidence of the generation and proliferation of T cells that were geared toward the tumor persisting for a long period of time thereafter, which will hopefully improve long-term outcomes.

Looking forward: This is another one of the understated stories in all the glitz and glamour of KEYNOTE-189. But BMY is currently a leader in investigating this neoadjuvant strategy in lung cancer, and it has real potential to make a big difference, in a similar way that AstraZeneca (AZN) did with the PACIFIC trial. By taking the fight to earlier stages of lung cancer, BMY stands to gain major advantages in the market. So this could be the beginning of a big move for it.

I still think this crush on BMY is overblown, and I won't be surprised if it pulls off a fairly big turnaround.

Celldex has a catastrophic setback

Company: Celldex Therapeutics (CLDX)

Therapy: Glembatumumab vedotin

Disease: Various cancers

News: CLDX announced that the top-line data from its phase 2 METRIC study in triple-negative breast cancer failed to deliver. This trial randomized patients to receive the antibody-drug conjugate glembatumumab vedotin or capecitabine for tumors overexpressing the marker targeted by the conjugate, gpNMB. The study failed to meet the primary endpoint of progression-free survival. And the company has announced that development of glembatumumab vedotin will be suspended across all indications.

Looking forward: Very bad news, and rather surprising, given the early signs of efficacy that have been observed in the past. It's also a major shock to the system for CLDX, which has now had several high-profile drug failures. While it's possible the company could recover with its remaining pipeline, that's what we said about rindopepimut's failure, and here we are.

At this time, CLDX presents far too high a risk proposition for my consideration.

Alkermes gets a surprise "come hither" from the FDA

Company: Alkermes (ALKS)

Therapy: ALKS 5461

Disease: Major depressive disorder

News: ALKS announced that the FDA has done an about-face on its refusal-to-file letter from March, accepting the NDA for its antidepression drug ALKS 5461 for review. This followed discussions with the agency where ALKS was able to demonstrate that the FDA had misunderstood what it saw as deficiencies in the data. An action date has been set for January 31, 2019.

Looking forward: Rather surprising news to see the FDA issue a sort of mea culpa of this sort. So now ALKS has its drug in review, with a few questions about data that will overhang. While its explanations were enough to get a review, will the data be sufficient for approval? This is unclear at this time, and I would personally consider this one anything but a sure bet.

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