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As ASCO begins, Iovance shows progress with cancer cell therapy

  • Iovance Biotherapeutics’ experimental immunotherapies continue to spur responses in patients with late-stage melanoma and cervical cancer, the California biotech said Friday.
  • The company will present data this weekend at the American Society of Clinical Oncology’s annual meeting from two ongoing Phase 2 studies of its adoptive T-cell therapies, which rely on a type of immune cell that’s capable of infiltrating tumors.
  • Iovance’s most advanced study is in advanced melanoma, where its treatment, lifileucel, has shrunk tumors in 25 of 66 treated patients. The company’s other program, dubbed LN-145, showed 12 of 27 patients responded to treatment. Both studies have yet to reach a median duration of response after a median of 8.8 months and 7.4 months, respectively, of follow-up.

While CAR-T therapies have attracted significant attention with success in treating blood cancers, Iovance is leading the way in developing another type of cell therapy that may prove effective in treating solid tumors.

The approach Iovance relies on was first developed in the 1980s and involves patient immune cells called tumor-infiltrating lymphocytes, or TILs.

TIL therapy starts with the removal of part of a patient’s tumor. TILs present in the sample are then isolated and expanded outside of the body, before being infused back into the patient. The hope is that by using patient immune cells already present in the tumor, TIL-based therapies can better target cancers and bring about longer-term responses.

Iovance licensed the technology in 2011 and has ambitions to market the first TIL therapy by 2021, pending an approval from the Food and Drug Administration. The biotech will aim first for an approval in advanced melanoma.

Results in that cancer type were from 66 patients with late-stage, unresectable melanoma who had already had three lines of prior treatment on average. Two patients treated with lifileucel achieved a complete response, while 23 experienced a partial one.

After nearly nine months of follow-up, the study has yet to yield a median duration of response, which Jefferies analyst Biren Amin called the most encouraging aspect of Iovance’s update.

Another biotech analyst said doctors have estimated nine to 12 months of response duration would be needed to gain significant traction in melanoma.

In March, Iovance dosed the first patient in a pivotal cohort of lifileucel that could support an application to the FDA.

The study in cervical cancer, meanwhile, showed similar results, albeit in a smaller population of 27 patients. Three patients saw a complete response, while nine experienced partial responses.

However, two of those patients appeared to have progressed, as the company stated only 10 have maintained a response. Patient-by-patient data, expected to be presented Saturday, could give further clarity.

After a median of seven months of follow-up, duration of response has also not been reached in the advanced cervical cancer trial. Current second-line treatment options carry a duration of response between three and five months, the lead study investigator said in a statement.

Iovance has been prepping for expansion, saying earlier this week it will spend $75 million over three years to build a commercial-scale cell therapy plant in Philadelphia. CEO Maria Fardis said in a February interview with BioSpace the company plans to grow its headcount by 25% as well in 2019.

The biotech’s stock has nearly doubled in value over the past two months, giving Iovance a market value north of $2 billion.