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3 Things In Biotech, May 4: Merck's New Combo, Alnylam Jump Starts, Ocata Gone Forever?

May 05, 2018 8:54 AM ETALNY, ALPMY, MRK7 Comments
Zach Hartman profile picture
Zach Hartman


  • Merck finally breaks out the combos in the tougher lung cancer.
  • Alnylam gets a potential headstart from the FDA on a new RNA therapy.
  • Astellas' Ocata show is a no-show.

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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.

Merck finally breaks out the combos in the tougher lung cancer

Company: Merck (MRK)

Therapy: Pembrolizumab

Disease: Squamous cell non-small cell lung cancer (NSCLC)

News: MRK has announced findings from its KEYNOTE-407 study, which is assessing the addition of pembrolizumab to standard chemotherapy for patients with squamous cell NSCLC. This differs from KEYNOTE-189, which looked at patients with non-squamous disease. KEYNOTE-407 has met its endpoint of overall response rate. Furthermore, based on the data it's gathered so far, MRK has submitted a supplemental drug application for approval of this combination in first-line treatment.

Looking forward: Stretching ever further, now into squamous cell disease. Just a few years ago, this was an extremely poor prognosis tumor type, and the emergence of immunotherapy has arguably impacted this subset of NSCLC most of all. I am eager to see a full data readout from this study, but I expect it will yield good results, and that the FDA will accept and approve the combo sometime in 2018.

Very good news for building the lung empire for pembrolizumab ever wider.

Alnylam gets a potential headstart from the FDA on a new RNA therapy

Company: Alnylam (ALNY)

Therapy: Lumasiran

Disease: Primary hyperoxaluria type 1 (PH1)

News: ALNY announced that it has reached an understanding with the FDA on a pivotal trial design for its RNA therapy lumasiran for the treatment of PH1. The primary endpoint for this study will be reduction in urinary oxalate

This article was written by

Zach Hartman profile picture
I am a former PhD scientist-turned-writer focused on cancer education. My writings in Seeking Alpha have been devoted to helping people identify promising investment opportunities in cancer research through commentary of recent events. Readers can learn more about other aspects of cancer research by visiting my site Invest Against Cancer.I also collaborate 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. If you are interested, please click the link above!

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