Merrimack Halts Phase II HERMIONE Study for Breast Cancer; Further Plans Revealed in January
December 21, 2016
By Mark Terry, BioSpace.com Breaking News Staff
Cambridge, Mass. – Merrimack Pharmaceuticals announced today that it was halting its Phase II HERMIONE study of MM-302 in HER2-positive metastatic breast cancer patients.
After the results of an independent Data and Safety Monitoring Board (DMB) recommendation, Merrimack decided to halt the trial. The drug, MM-302 (HER2 antibody-targeted liposomal doxorubicin) was being evaluated in HER2-positive metastatic breast cancer patients who had received previous treatment with trastuzumab (Herceptin), pertuzumab (Perjeta) and ado-trastuzumab emtansine (T-DM1, Kadcyla).
There were no safety concerns. Rather, the DSMB and further analysis showed that the drug did not show benefit over the treatments it was being compared to. In fact, both the treatment and control arms showed shorter than expected median progression free survival.
Patients currently receiving the drug in the trial have the option to continue after discussing it with their physician.
“Late line HER2-positive breast cancer is very difficult to treat, especially in this new and previously unstudied group of patients who appear to experience rapid cancer progression following treatment with trastuzumab, pertuzumab and ado-trastuzumab emtansine,” said Istvan Monar, vice president of Clinical Development at Merrimack, in a statement. “While we are disappointed with this outcome, we would like to thank the study Steering Committee, the investigators and, most importantly, the patients who participated in the HERMIONE trial. We will report our learnings from this study at a later date.”
Merrimack took a hit, dropping from $5.37 yesterday to its current price of $4.42. It’s been a rocky ride for the company’s stock this year. It hit $8.75 on March 22, dropped to $4.45 on September 9, and recently had hit $6.68 on November 15.
According to Hotstockpoint.com, on a scale from 1.0, meaning a Strong Buy to a 5.0, meaning Strong Sell, analysts’ mean recommendation for the company is 2.60. Essentially a “Hold” recommendation.
In late October, Bret Jensen, writing for Seeking Alpha, cited Merrimack as one of three promising biotech stocks that at that time were selling for about $5 per share. In 2015, its first product, Onivyde (irinotecah liposome injection) was approved by the U.S. Food and Drug Administration (FDA), and then approved this October in Europe for pancreatic cancer. Shire holds the European rights, but will likely improve Merrimack’s royalty stream. In the second quarter of this year, Onivyde created about $13 million in net revenue, a 30 percent increase year-over-year. The drug is being evaluated in a Phase II trial for front-line pancreatic cancer. It also plans to start a Phase III trial of the drug in small-cell lung cancer soon. It also had three other cancer drugs in mid-stage development.
On October 3, the company announced that it was cutting 22 percent of its staff as part of a major corporate restructuring. The focus was on prioritizing its research and development on oncology and giving it a longer financial runway. At the time, the company’s former president and chief executive officer, Robert Mulroy, also resigned. He was replaced by Gary Crocker on an interim basis. Crocker is chairman of the company’s board.
The company plans a further update of its plans in January.