3 Things In Biotech, April 20: AstraZeneca Re-Enters The Big Leagues, Aduro Looks Ahead, Lilly Looks Close

Includes: ADRO, AZN, LLY
by: Zach Hartman

AstraZeneca starts the big fight in EGFR-positive lung cancer.

Aduro teed up a new antibody therapy at AACR.

Lilly gets its materials for a big meeting with the AAC.

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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 starts the big fight in EGFR-positive lung cancer

Company: AstraZeneca (AZN)

Therapy: Osimertinib

Disease: EGFR-mutant non-small cell lung cancer

News: AZN announced approval for osimertinib in the treatment of previously untreated EGFR-positive non-small cell lung cancer. This came as little surprise, given the findings from the phase 3 FLAURA study, which demonstrated superior progression-free survival for osimertinib over erlotinib/gefitinib in the first-line setting.

Looking forward: Now the big fight begins, with osimertinib out in the lead. A few days ago, I prepared an article describing the coming fight for first-line dominance between osimertinib and dacomitinib (read that here). This is definitely going to give AZN a huge boost in the fight, being the first to market. That and for all intents and purposes, it appears as though osimertinib is the better drug. But it still remains unclear at this time whether clinicians should hold the "best" drug for later lines of therapy so they can extend their options. And for that we'll need longer-term follow-up from the FLAURA study.

Excellent news for AZN, and I expect the company to translate it into gained ground in this space.

Aduro teed up a new antibody therapy at AACR

Company: Aduro Biotech (ADRO)

Therapy: BION-1301

Disease: Multiple myeloma

News: At AACR, ADRO presented findings from an emerging treatment targeting a cell surface antigen called APRIL, which might have efficacy in multiple myeloma. This antibody, BION-1301, is the subject of an ongoing phase 1/2 trial, and these preclinical findings show that the antibody is capable of reducing the immunoglobulin burden characteristic of myeloma in mice. This suggests that this could be a viable treatment strategy for patients.

Looking forward: Count on ADRO to attack another 5-letter acronym. First STING, now APRIL. We don't know much about this just yet, other than ADRO has a track record of bringing interesting antibody therapies to clinic, and this anti-APRIL antibody is already being tested in humans. Thus, it gets my attention.

This may be another stone added to the foundation of ADRO.

Lilly gets its materials for a big meeting with the AAC

Company: Eli Lilly (LLY)

Therapy: Baricitinib

Disease: Rheumatoid arthritis

News: The FDA announced an upcoming committee meeting between LLY and the Arthritis Advisory Committee, wherein the two entities will discuss the new drug application for baricitinib in the treatment of moderately to severely active rheumatoid arthritis. This meeting will take place on April 23, 2018. Key questions that the committee will vote on pertain to the efficacy of baricitinib, both at the 2 mg and 4 mg doses. Furthermore, it remains to be seen whether the safety profile allows for a favorable-enough risk/benefit ratio to allow for approval.

Looking forward: The meeting, first announced back in March, continues as planned. The briefing documents seem to indicate overall that the committee generally regards the application favorably, in spite of the initial rejection last August. Lingering safety issues may yet sink the ship, but the resubmission's alternative dosing proposal should help.

It seems likely at this point that at least one dose of baricitinib will be approved.

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