Iovance Biotherapeutics Shares Rise 12% After Positive Lung Cancer Therapy Trial Data

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)

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