Iovance Biotherapeutics Inc (NASDAQ: IOVA) received a request from the US FDA for more data for its drug – Lifileucel for use in the US.
Iovance provided additional clinical data for Lifileucel in combination with Merck & Co Inc’s (NYSE: MRK)’s an innovative drug – Pembrolizumab and as a standalone treatment for patients suffering from melanoma. The company will offer additional updates on the combination and standalone studies at the forthcoming ASCO annual conference which will be held between June 4 and June 8, 2021.
Iovance’s CEO, Maria Fardis, said the company is thrilled with its latest clinical data that shows a broad potential for its innovative formulation – Lifileucel to cure patients with advanced melanoma.
Overall response rate at 86%
In the clinical trial, the combination of Pembrolizumab and Lifileucel showed an ORR (Overall Response Rate) of 86% in people naïve to APT (anti-PD-1 therapy). Maria said the results are impressive because pembrolizumab as a standalone drug showed an ORR of 33%. Following the data readout, its shares edged higher by 17.14% on May 20, 2021.
Iovance is developing Lifileucel to treat metastatic cervical cancer and metastatic melanoma. It already provided potency assay data to the US FDA to support its BLA (biologics license application). The company expects to apply for BLA this year.
Iovance did not post any revenues in Q1 2021 because of the non-availability of any marketable products or collaborations to boost revenues.
Iovance R&D expenses are declined by 1.8% QoQ to $55.9 million in Q1 2021. It is on the backdrop of reduced clinical and manufacturing costs.
Iovance G&A expenses rose by 41% to $19.6 million because of a rise in associated personal costs. The company holds cash, short-term investments, and a cash balance of $610.2 million in Q1 2021.
Iovance plans to offer improved patient care by providing access to its T Cell-based immunotherapies. It helps to treat patients with blood cancers and solid tumors.
The company uses immune cells collected from the patient’s tumor tissues in its TIL (Tumor-infiltrating lymphocyte) therapy to cure cancer. TIL reaches the tumor tissues upon infusion and attacks cancer cells.
Iovance is conducting clinical studies to examine the efficacy of TIL in early-stage cancers by combining it with other approved treatments.
