Dashed Hopes in the Mesothelioma Community After COMMAND Trial Stops Enrollment

The mesothelioma community received a stunning blow last week with the news that Verastem is halting its COMMAND clinical trial. The company announced Sept. 28 that it will “stop enrollment for futility” in the trial of its focal adhesion kinase inhibitor drug, VS-6063, or defactinib.

According to a Sept. 28 Verastem press release, the international trial will undergo “an orderly wind-down” after a data safety monitoring board found that VS-6063, when given to mesothelioma patients as part of the COMMAND (Control Of Mesothelioma with MAiNtenance Defactinib) trial, did not produce “a sufficient level of efficacy” to justify continuation.

“We are disappointed with the COMMAND outcome, but we are deeply grateful for the support and commitment from the patients participating in the study, their families, and the study investigators,” said Robert Forrester, Verastem President and Chief Executive Officer.

Verastem also noted in the press release that there was, “no difference in VS-6063 versus placebo in either the intent to treat population or patients with Merlin-low tumors.”

Defactinib targets cancer stem cells that have been shown to survive the effects of anti-cancer drugs allowing them to continue to grow and divide, causing the cancer to metastasize. In the trial, defactinib was combined with paclitaxel, an anti-cancer drug that is often used in combination with other drugs for various cancers. The drug also targets patients who lack the merlin protein, believed to play a role in controlling cell shape, cell movement, and communication between cells.

According to ClinicalTrials.gov, Verastem had hoped to target 372 malignant pleural mesothelioma patients who have undergone one prior chemotherapy cycle of either pemetrexed/cisplatin or pemetrexed/carboplatin.

In June 2014, Verastem announced promising early results of the trial. The company reported of the 22 patients in the U.S. participating in the clinical trial, 14 (64%) “achieved a best overall response of at least stable disease including two partial responses and two complete responses to date.” The trial began in Sept. 2013.

“Malignant pleural mesothelioma is among the most aggressive and lethal cancers with only one approved therapy,” said Lou Vaickus, MD FACP, Interim Chief Medical Officer. “With the aggressiveness of this disease, the use of single agent VS-6063 as a maintenance treatment following chemotherapy where all patients had residual disease was not sufficient. There remains a significant unmet medical need for new treatment options for patients suffering from this very complex, difficult-to-treat cancer.”

Mesothelioma is currently diagnosed in nearly 3,000 Americans each year. The cancer is very aggressive and is resistant to many of the standard treatments available. Researchers will continue to search for a novel therapy that will turn this incurable cancer into one that can be stopped in its tracks, and give patients longer, quality lives.

Sources:

• Verastem press release
  http://phx.corporate-ir.net/phoenix.zhtml?c=250749&p=irol-newsArticle&ID=2090793&highlight=
• ClinicalTrials.gov
  https://clinicaltrials.gov/ct2/results?term=%22malignant+mesothelioma%22&recr=Open&pg=1