3 Things In Biotech, April 10: Major Wins For Merck, AbbVie, And Verastem
Summary
- Merck poises to flip the lung cancer table.
- AbbVie sticks a phase 3 landing.
- Verastem is a priority with the FDA.
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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.
Merck poises to flip the lung cancer table
Company: Merck (MRK)
Therapy: Pembrolizumab
Disease: Non-small cell lung cancer
News: MRK announced that the phase III KEYNOTE-042 study met its primary endpoint of overall survival. This study compared the PD-1 antibody pembrolizumab to chemotherapy as first-line treatment for non-small cell lung cancer that expresses PD-L1 at a 1% cutoff. This stands in direct contrast to CheckMate-026, which failed to demonstrate an improvement in progression-free survival for nivolumab compared with chemotherapy.
Looking forward: This is a very big potential game changer. Pembrolizumab is already approved for first-line non-small cell lung cancer, but this was in a rather restricted population (those with a PD-L1 ≥50%). Disease with 1% or more PD-L1 expression likely represents the majority of patients. But now it's totally clear why one worked whereas the other didn't. Different populations? PD-L1 not being a good biomarker? Maybe pembrolizumab is actually better tha nivolumab? At this point, we really need the full data. In the meantime, MRK stands to benefit mightily with these data, which will very likely lead to approval.
Massive news for MRK, which already was building a dominant position in the space.
AbbVie sticks a phase 3 landing
Company: AbbVie (ABBV)
Therapy: Upadacitinib
Disease: Severe rheumatoid arthritis
News: ABBV announced that the phase 3 SELECT-COMPARE study has met its primary endpoints of improvement in rheumatoid arthritis symptoms and clinical response for their JAK1 inhibitor upadacitinib compared with placebo. The study also met secondary endpoints, notably with respect to clinical symptom improvements compared with standard adalimumab. No new safety signals were observed in the study.
Looking forward: First ABBV secures a position for adalimumab for quite a while, and then they get this heir apparent moving toward the home stretch. If approved, upadacatinib could prove to be another blockbuster drug, on par with something like ruxolitinib, although that agent isn't indicated in rheumatology.
Still, this is great news for ABBV, at least insofar as they can increase relevance in rheumatology.
Verastem is a priority with the FDA
Company: Verastem (VSTM)
Therapy: Duvelisib
Disease: Chronic lymphocytic leukemia and follicular lymphoma
News: VSTM announced that the FDA has accepted its new drug application seeking approval for their PI3K inhibitor duvelisib in patients with relapsed/refractory chronic lymphocytic leukemia or follicular lymphoma. The application was also granted priority review status, shortening the time the FDA has to render a decision. The action date on this application has been set for October 5, 2018.
Looking forward: This news should assuage the concerns of the investors who are asking me fairly often about my opinion of VSTM. The FDA allowing the application to move forward is a good sign. The FDA granting the application priority review is a better sign. Of course, this is by no means a guarantee of approval, but it is definitely positive! That said, in my opinion it appears as though duvelisib offers the same hope for disease control as idelalisib, without the gray cloud of toxicity that tanked its prospects.
Excellent news for VSTM, and now it will be a long wait until October for shareholders.
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