Iovance Biotherapeutics Shares Rise 12% After Positive Lung Cancer Therapy Trial Data
10 Julho 2023 - 11:56AM
Dow Jones News
By Chris Wack
Iovance Biotherapeutics shares were up 12% to $8.09 Monday after
the company said it saw positive regulatory and clinical news
related to IOV-LUN-202, its registrational single-arm phase 2 trial
of its LN-145 tumor therapy in post-anti-PD-1 non-small cell lung
cancer.
While still early, a preliminary analysis in the IOV-LUN-202
trial showed that the median duration of response wasn't reached.
Treatment-emergent adverse events were consistent with the
underlying disease and known adverse event profiles of
non-myeloablative lymphodepletion and interleukin-2.
The early trial was based on positive regulatory feedback from a
Type B pre-phase 3 meeting held between Iovance and the U.S. Food
and Drug Administration.
At the meeting, the FDA said the design of the trial might be
acceptable toward accelerated approval of LN-145 tumor infiltrating
lymphocyte therapy in patients who have progressed on or after
chemotherapy and anti-PD-1 therapy and who had received at least
one line of an FDA-approved targeted therapy, if indicated by other
actionable tumor mutations.
Based on the regulatory discussions, Iovance also plans to
enroll a total of 120 patients in the registrational trial.
Enrollment is expected to be completed during the second half of
2024.
Iovance is preparing to meet with the FDA this year to discuss
another randomized confirmatory trial of LN-145 in frontline
advanced non-small cell lung cancer patients.
Write to Chris Wack at chris.wack@wsj.com
(END) Dow Jones Newswires
July 10, 2023 10:41 ET (14:41 GMT)
Copyright (c) 2023 Dow Jones & Company, Inc.
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