by Phil Taylor |
Apr 24, 2018 8:55am
Shares in Epizyme slipped in premarket trading today after the
company announced a suspension of patient recruitment in a trial of its lead
cancer drug after a patient developed a secondary lymphoma, but analysts at
Jefferies are expecting the stock to bounce back.
The company says the FDA has implemented a
partial clinical hold on its trials of tazemetostat, which means it cannot
enroll new patients with genetically defined solid tumors and hematologic
malignancies. Patients already taking the drug can, however, continue to
receive it in the meantime, and enrollment outside the U.S. is currently
unaffected.
The news has put pressure on Epizyme’s shares, which were down
12% this morning. Jefferies points out that several other companies have been
in this situation—including Juno and Cellectis—and suggests the company will
move quickly to “modify the protocol and trial brochures and get back up and
running.” They anticipate a holdup of just a few months.
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Tazemetostat is an inhibitor of EZH2, an enzyme which is
overexpressed in multiple cancers and has been described as a “master switch” that helps malignant cells
divide and proliferate. Epizyme is at the forefront of attempts to explore
the role of the class in oncology, a little ahead of other players including
Constellation Pharma which raised $100 million to advance its
CPI-1205 candidate earlier this month.
The partial hold came after a patient in Epizyme’s pediatric
phase 1 study with cancer of the skull/spine, who was receiving a higher dose
of tazemetostat than is being tested in Epizyme’s phase 2 program in adults,
developed a secondary T-cell lymphoma and had in fact shown a partial response
to the drug.
“More than 750 patients have been treated with tazemetostat to
date, and this is the only case of secondary lymphoma that has been observed
across the tazemetostat clinical program,” says Epizyme.
The biotech’s published information shows that this type of
cancer has been seen in animals exposed to tazemetostat, which Jefferies says
could be behind the FDA’s cautious stance. However, as patients with this type
of cancer typically undergo often undergo radiotherapy and aggressive
chemotherapy, they are already at an increased risk of T-cell lymphoma,
according to Jefferies, which notes that this type of cancer “is treatable with
survival outcomes.”
They suggest that “based on preclinical data … and at least one
case in patients here today, that any future potential label would probably
have warning section or something on this—and this would not hamper the drug as
the drug is for severe deadly cancers with no alternatives.”
Tazemetostat is being tested as a monotherapy in several phase 1
and 2 studies, including patients with epithelioid sarcoma, follicular
lymphoma, diffuse large B-cell lymphoma (DLBCL) and mesothelioma, and is also
in combination trials in DLBCL and non-small cell lung cancer (NSCLC).
“We are working expeditiously with clinical trial investigators
and regulatory authorities to initiate the appropriate steps to resume
enrollment,” says Robert Bazemore, Epizyme’s president and chief
executive.
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