- Merrimack gets rolling in HER2-positive breast cancer.
- Eli Lilly expands the range for their CDK4/6 inhibitor.
- Actinium heads forward with trial site accrual.
Note: Subscribers to Avisol Capital Partners Total Pharma Tracker got an early look at this publication.
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.
Merrimack gets rolling in HER2-positive breast cancer
Company: Merrimack Pharmaceuticals (MACK)
Disease: HER2-negative breast cancer
News: MACK announced that the first patient in their SHERBOC study has been enrolled. SHERBOC is a phase 2 trial investigating the HER3 inhibiting antibody seribantumab in patients with heregulin-positive metastatic breast cancer. This will enroll patients who have had exposure to other treatment options, including CDK4/6 inhibitors.
Looking forward: This is an important development for MACK targeting a molecule that hasn't really been a major focus in oncology to date. This is interesting, but it also makes me nervous when prognosticating on the benefit of this approach. We simply don't know until a trial like SHERBOC lets us know. So for a prospective investor, this is definitely a high-risk/high-reward proposition in an area of substantial need.
Too much risk for me, personally, but there is promise to this approach
Eli Lilly expands the range for their CDK4/6 inhibitor
Company: Eli Lilly (LLY)
Disease: ER-positive breast cancer
News: LLY announced that the FDA has expanded the approved label for their CDK4/6 inhibitor abemaciclib to be allowed for patients who have had no prior endocrine therapy for metastatic, ER-positive breast cancer. This builds on the previous approvals for either single-agent therapy or in combination with fulvestrant with disease progression.
Looking forward: This is the final step that LLY needed to take to get abemaciclib on the same footing as the other CDK inhibitors, which have both been approved for first-line therapy. Now we need to see if the dosing regimen will make a big difference in terms of market share, or whether the prevailing approvals of ribociclib and palbociclib will carry them through.
For now, however, this is definitely great news for LLY's bottom line
Actinium heads forward with trial site accrual
Company: Actinium Pharmaceuticals (ATNM)
Disease: Acute myeloid leukemia
News: ATNM gave an update on the accrual of trial sites for their phase 3 SIERRA study, which is evaluating the benefit of Iomab-B in patients with relapsed/refractory acute myeloid leukemia. The company has activated its 16th trial site, which will be used to help with the target enrollment of 150 patients. Iomab-B is designed to deliver radiation directly to bone marrow cells, helping to protect other tissues during lymphodepleting therapy. The study will assess the six-month rate of complete remission compared with conventional therapy.
Looking forward: ATNM guided that the 16 trial sites involved in SIERRA so far represent one-third of all bone marrow transplant volume, which will be important for finding the appropriate number of patients, since AML is a rare form of leukemia, and patients who are suitable for bone marrow transplant are also not common. So while it may seem excessive, this many trial sites will hopefully help ATNM get the trial done expeditiously.
This kind of news isn't quite good enough for me to consider a buy-in, but it does signal that the trial is coming along well, and we'll want to watch out for more.
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