What happened
Shares of Iovance Biotherapeutics (IOVA -2.81%), a clinical-stage biotechnology company, are on the move after a clinical program update. Investors who are pleased to see the company's oncology candidates getting closer to the finish line pushed the stock 20.4% higher on Wednesday.
So what
Iovance recently expanded a phase 2 melanoma study with its lead candidate, lifileucel, an individualized cellular therapy that makes use of tumor-infiltrating lymphocytes (TIL) derived from patients' own tumors. The company didn't get much attention after dosing the first patient yesterday, but today's announcement hit the right notes.
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Iovance thrilled investors by announcing an intention to expand an ongoing phase 2 cervical cancer trial with lifileucel to 59 patients in anticipation of an upcoming meeting the company hopes to have with the Food and Drug Administration. At this meeting, the company will pitch its plan to modify the single-arm study's primary endpoint of objective response rate in a way that could support a new drug application.
Iovance also told investors it plans to close a phase 2 lung cancer study with lifileucel, and instead include lung cancer patients in a catchall solid-tumor study.
Now what
Investing heavily in an unproven autologous cellular cancer therapy by starting multiple pivotal studies might not be a great idea right now. In phase 2, lifileucel shrank tumors for 38% of advanced-stage melanoma patients treated, which is pretty good for this population. Before you get excited, it's important to remember a majority of patients' tumors started growing again within 6.4 months.
Although Iovance said the FDA will accept an application supported by a single-arm study for melanoma, the company hasn't run its plans for cervical cancer past the regulator yet. Amending a clinical trial's protocol to support a new drug application, without telling the FDA ahead of time, rarely works out as well as hoped.
