What happened
Shares of Iovance Biotherapeutics (IOVA 3.82%) were up 10.2% as of 3:24 p.m. EDT on Monday. Investors viewed the biotech as one of the big winners so far from the American Society of Clinical Oncology (ASCO) annual meeting. Iovance presented updated data over the weekend from clinical studies evaluating its immunotherapies in treating advanced cervical cancer and advanced melanoma.
So what
Investors were especially excited about the durability of responses reported by Iovance for its tumor-infiltrating lymphocyte (TIL) immunotherapies. A median duration of response (DOR) had not been reached for the biotech's phase 2 clinical study evaluating TIL drug LN-145 in treating advanced cervical cancer or in the phase 3 study evaluating lifileucel in treating advanced melanoma. That's especially impressive considering that the duration of response for current second-line treatments approved to treat advanced cervical cancer are in the range of three to five months.
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There was also good news in both studies related to patients' complete responses (CRs) -- the complete disappearance of all signs of cancer. CEO Maria Fardis said that the biotech was "extremely encouraged to see CRs in our cervical cancer study" after only one treatment. She added, "The same phenomenon was noted in our melanoma trial as well with two CRs now being reported at ASCO in heavily pre-treated melanoma patient population."
Iovance also reported that as of May 14, 2019, patients receiving LN-145 had demonstrated an objective response rate (ORR) -- tumor shrinkage meeting predefined levels -- of 44%. The company said that as of May 8, 2019, patients on Cohort 2 of its phase 3 study evaluating lifileucel in treating melanoma demonstrated an ORR of 38%.
Now what
Iovance still must complete its clinical studies, but the data presented at ASCO is certainly encouraging. The company appears to be on track to file for approval of lifileucel in treating advanced melanoma by late 2020. It also plans to meet with the Food and Drug Administration later this year to discuss the regulatory approval pathway for LN-145 in treating cervical cancer.
